The approach of neoadjuvant therapy for breast cancer, which involves administering systemic treatment prior to primary surgery, has undergone substantial advancements in recent decades. This strategy is intended to reduce tumor size, thereby enabling less invasive surgical procedures and enhancing patient outcomes. This study presents a comprehensive bibliometric analysis of research trends in neoadjuvant therapy for breast cancer from 2009 to 2024. Using data extracted from the Web of Science Core Collection, a total of 3,674 articles were analyzed to map the research landscape in this field. The analysis reveals a steady increase in publication output, peaking in 2022, with the United States and China identified as the leading contributors. Key institutions, such as the University of Texas System and MD Anderson Cancer Center, have been instrumental in advancing the research on neoadjuvant therapy. The study also highlights the contributions of influential authors like Sibylle Loibl and Gunter von Minckwitz, as well as major journals such as the Journal of Clinical Oncology. Emerging research topics, including immunotherapy, liquid biopsy, and artificial intelligence, are gaining prominence and represent potential future directions for clinical applications. This bibliometric analysis provides critical insights into global research trends, key contributors, and future developments in the field of neoadjuvant therapy for breast cancer, offering a foundation for future research and clinical practice advancements.

Neoadjuvant therapies can result in pathologic complete response (pCR) in patients with breast cancer, which can be predictive of long-term outcomes. Patients with estrogen receptor positive (ER +) tumors may receive either neoadjuvant chemotherapy (NAC) or neoadjuvant endocrine therapy (NET). We sought to compare survival outcomes in those with non-metastatic ER + breast cancer who received NET or NAC and achieved pCR.

All patients diagnosed with ER + /HER2- stage I-III breast cancer, who received neoadjuvant systemic therapy followed by surgery, and achieved pCR, were selected from the National Cancer Database (NCDB, 2010-2021). The Kaplan-Meier method was used to estimate overall survival (OS), and log-rank tests were used to test for differences in OS. Cox Proportional Hazards models were used to estimate the association of NAC vs NET with OS, after adjustment for covariates.

3313 patients met eligibility criteria: 3148 received NAC and 165 NET. The median follow-up for the entire cohort was 82 months (95% CI 80.4-83.1). Patients who received NAC were significantly younger (median age: NAC 49y vs NET 64y; p < 0.001), more likely to have a comorbidity score of 0 (NAC 89.3% vs NET 81.2%, p = 0.004), and more likely to have private insurance (NAC 68.9% vs NET 44.2%, p < 0.001). There were no significant differences between the NAC and NET patients based on race and ethnicity, income, education, or community type (all p > 0.05). The NAC treated patients were more likely to have larger tumors [median tumor size (IQR): NAC 3 cm (2.0-4.3) vs NET 1.3 cm (0.7-2.8); p < 0.001)], ductal histology (NAC 92.6% vs 81.2%, p < 0.001), and grade 3 tumors (NAC 70.2% vs 10.3%, p < 0.001). In the unadjusted Kaplan-Meier analysis, there was no significant difference in OS between NAC vs NET [5-year OS: NAC 0.935 vs NET 0.916; p = 0.08]. After adjustment for demographics, disease characteristics, and treatments, there remained no association between OS and study group (NAC vs NET; p = 0.63).

Patients with ER + /HER2- early-stage breast cancer who achieved pCR had similar OS, regardless of whether they received NAC or NET. As such, pCR appears to have similar prognostic value irrespective of the type of systemic therapy used to obtain this favorable outcome.

There is limited clinical evidence of docosahexaenoic acid (DHA) efficacy during breast cancer neoadjuvant chemotherapy (NAC). This randomized, double-blind, placebo-controlled trial aimed to investigate the safety and efficacy of DHA supplementation in breast cancer patients undergoing NAC. Participants (n = 49) were assigned to receive either DHA 4.4 g/day orally (algae triacylglycerol) or a placebo (corn/soy oil) over six cycles (18 weeks) of NAC. The primary outcome was the evaluation of changes in the percentage of Ki-67 expression, assessed by immunohistochemistry analysis from pre- to post-treatment. Secondary outcomes included pathological complete response, incidence of adverse effects, and 3-year survival analysis. Compliance was evaluated by fatty acid analysis of plasma phospholipids and erythrocyte total lipids quantified by gas-liquid chromatography. The expression of Ki-67 significantly decreased in both groups, with no significant effects of the DHA intervention (p = 0.38). When stratified by breast cancer subtype, there was a trend of greater reduction in Ki-67 expression in the human epidermal growth receptor 2 (HER2+++) subtype in the DHA group compared to placebo (p = 0.1). The % of DHA in erythrocytes and plasma phospholipids was increased by two-fold at 9 and 15 weeks of therapy in the DHA group, while it remained unchanged in the placebo group (p-interaction <0.001). There was no reported incidence of adverse effects related to the intervention, and no significant effects were found in the other secondary outcomes. NAC significantly decreased the expression of Ki-67, with no additional beneficial effects observed by DHA supplementation. Further research is necessary to confirm these findings.

Evaluation of pathological complete response (pCR) [no residual invasive carcinoma in the breast (RIC) or lymph node metastases (LNM) in surgical specimens following therapy] is typically based on evaluation of one level of haematoxylin and eosin (H&E) section. Not achieving pCR is associated with worse outcomes, and additional therapy may ensue. This study of patients with triple-negative (TNBC) or human epidermal growth factor receptor 2 (HER2)-positive (HER2+) breast cancer who underwent neoadjuvant therapy aims to assess whether occult residual disease (ORD) can be identified in deeper sections of tumour beds and lymph nodes in cases originally reported as pCR and whether ORD is associated with worse outcomes.

In 84 cases of pCR (2009-17) at our institution, deeper-level recuts were assessed for ORD. Oncological and survival outcomes were compared. ORD was identified in seven of 40 TNBC (17.5%; five RIC; one LMN; one RIC and LMN) and four of 44 HER2+ (9.1%; three RIC; one LMN) cases (all residual cancer burden I). Median follow-up was 46.7 months for TNBC (one local recurrence, four distant metastases and two deaths) and 86.8 months for HER2+ (no local recurrence, three distant metastases and two deaths). All recurrence and death events occurred in patients with pCR without ORD, with no recurrence events in patients with ORD.

In patients with TNBC and HER2+ breast cancer with pCR by standard pathological assessment, occult residual disease is not uncommon. Occult disease was not associated with worse oncological or survival outcomes, suggesting standard pathological assessment is sufficient to identify clinically meaningful disease.

Residual disease after neoadjuvant chemotherapy (NAC) has important role in triple negative breast cancer (TNBC). The CREATE-X study demonstrated a survival benefit from adjuvant capecitabine (adjC) in breast cancer patients, especially for TNBC populations. Because the landscape of early TNBC treatment has been changing rapidly, an optimal adjuvant strategy for real-world practice is needed. We evaluated the effectiveness of adjC in TNBC patients with residual disease after NAC.

We used de-identified, anonymous data from an institutional clinical data warehouse to retrospectively analyze 934 TNBC patients who received NAC between 2017 and 2023. Among them, 405 patients received at least 1 cycle of adjC, and 77 received no adjuvant treatment. The primary outcomes of the study were distant-disease free survival (DDFS) rate and overall survival (OS) rate at 3 years. The secondary outcomes were subgroup analyses and Cox regression analyses of survival outcomes.

The median follow up period was 34.3 months (range 1.8-71.5). The DDFS rate at 3 years was higher in the capecitabine group: 86.3% of the capecitabine group and 74.4% of the no adjuvant group (P = .019). The OS rates at 3 years were 93.3% and 83.8%, respectively (P = .032). Subgroup analyses indicated a greater benefit from adjC in patients aged 50 years or older and those who received platinum-based NAC, both in terms of DDFS and OS.

Our study showed that adjC was more effective than no adjuvant treatment for TNBC patients with residual disease in terms of DDFS and OS.

Human epidermal growth factor receptor 2 (HER2)-negative operable breast cancer (BC) patients with germline BRCA1/2 pathogenic variants may benefit from adjuvant olaparib treatment. However, data about how many patients were eligible for olaparib treatment in operable BC patients with BRCA1/2 variants after neoadjuvant chemotherapy (NACT) is lacking.

A total of 341 operable BC with germline BRCA1/2 pathogenic variants who received NACT at our institute between October 2003 and May 2015 were included. Pathological complete response (pCR) and survival were estimated.

Of the 341 BRCA1/2 carriers (BRCA1: 139; BRCA2: 202), 295 (88.1%) cases exhibited HER2-negative BC in the entire cohort. The most common subtype was triple-negative (TN) BC (62.0%) for BRCA1 carriers and hormone receptor (HR)-positive/HER2-negative BC (68.2%) for BRCA2 carriers, respectively. The pCR rate were 39.6% for BRCA1 carriers and 28.2% for BRCA2 carries. The pCR rate in TNBC, HR-positive/HER2-negative BC, and HER2-positive BC were 45.0%, 22.3%, and 45.0% in the entire cohort, respectively. Of these HR-positive/HER2-negative BC patients, 16.0% had non-pCR and exhibited CPS+EG≥3. Overall, 31.9% of the HER2-negative BC cohort were potential candidates for adjuvant olaparib, with 44.0% for BRCA1 carriers and 22.9% for BRCA2 carriers. Furthermore, patients with non-pCR exhibited a worse survival regardless of TNBC and HR-positive/HER2-negative BC disease, especially for HR-positive/HER2-negative BC with CPS+EG≥3.

Approximately one-third of HER2-negative BC patients with BRCA1/2 pathogenic variants are potential candidates for adjuvant olaparib treatment after NACT, with a higher proportion for BRCA1 carriers compared to BRCA2 carriers.

The combination of pembrolizumab with neoadjuvant chemotherapy (NAC) for triple-negative breast cancer (TNBC) improves pathologic complete response (pCR) rates and event-free survival. Yet it is unclear which patients benefit most from the addition of immunotherapy. This study aims to identify predictive factors for pCR in patients with TNBC receiving chemo-immunotherapy (chemo-IO).

This single-institution retrospective analysis included 283 consecutive patients with TNBC treated with neoadjuvant chemo-IO from 1 June 2021 to 20 January 2023. The primary outcome was overall pCR; secondary outcomes were breast pCR and nodal pCR. Univariate and multivariable logistic regression models assessed for characteristics associated with overall, breast, or nodal pCR.

Most patients presented with cT2 (71%) cN0 (54%) disease. The overall pCR rate was 57%, breast pCR was 58%, and axillary pCR was 67% among biopsy-proven cN+ patients. Race, pathogenic BRCA mutations, backbone chemotherapy regimen, immune-related adverse events, and disruptions in immunotherapy were not associated with pCR. Univariate associations with overall pCR were younger age (p = 0.04), lower clinical T stage (p = 0.01), ductal histology (p < 0.001), poor differentiation (p < 0.001), and unifocality (p < 0.001). Breast and axillary pCR had similar associations. Nodal pCR also had univariate associations with normal body mass index (BMI) (p = 0.04) and absence of lymphovascular invasion (LVI) (p = 0.04). On multivariable analyses, ductal histology and unifocality remained independently associated with overall and breast pCR.

This analysis showed few clinical variables to be independently associated with pCR after neoadjuvant chemo-IO for TNBC. Thus, predicting chemo-IO response to personalize treatment and minimize morbidity may instead lie in ongoing basic and translational research to assess for useful biomarkers.

The prognostic value of pathological complete response (pCR) in HR+/HER2- breast cancer patients following neoadjuvant chemotherapy (NAC) is limited, as many of these patients achieve long-term survival regardless of pCR status. The effectiveness of current tools-residual cancer burden (RCB), the Miller-Payne (MP) score, CPS-EG score and the immunohistochemical 4 (IHC4)-in this subgroup remains uncertain. In this study, we validated the prognostic role of these approaches and developed a COMBINED score capable of more accurately stratifying patients into distinct risk groups, effectively identifying low-risk patients with favorable outcomes who may be suitable for treatment de-escalation.

This study retrospectively analyzed 601 HR+/HER2- breast cancer patients at Sun Yat-sen Memorial Hospital who did not achieve pCR following NAC. Patients were stratified using the IHC4, RCB, MP, CPS-EG, and a novel COMBINE score (integrating CPS-EG and IHC4). Survival outcomes, including disease-free survival (DFS) and overall survival (OS), were evaluated using Kaplan-Meier analysis and Cox regression, with time-dependent ROC and concordance index (C-index) calculations to assess prognostic performance.

The IHC4 and CPS-EG scores outperformed the RCB and MP scores in predicting DFS and OS for non-pCR HR+/HER2- patients. The COMBINE score further enhanced prognostic accuracy, stratifying patients into four risk groups with significant differences in 5-year DFS (96.5% for low-risk vs. 55.1% for high-risk) and OS (100% for low-risk vs. 63.4% for high-risk). The COMBINE score consistently demonstrated superior AUC and C-index values compared to the CPS-EG and IHC4 scores individually at all time points (all p-values < 0.05).

The IHC4 score adds prognostic value beyond the CPS-EG score in HR+/HER2- breast cancer patients post-NAC. The COMBINE score, integrating both systems, offers superior prognostic stratification, highlighting the importance of combining clinical staging with tumor biology. Future studies with independent datasets are needed to validate these findings. This study provides valuable insights for optimizing treatment decisions in HR+/HER2- breast cancer.

More data is needed for those patients with aggressive tumor biology with a high recurrence risk for de-escalating axillary surgery in clinically N+ breast cancer. We, therefore, investigated the outcome in cN+ patients with HER2+ or triple-negative breast cancer who were treated with sentinel lymph node biopsy alone following neoadjuvant systemic treatment.

Clinically N+ patients (cT1-4N1-3M0) with HER2+ and triple-negative breast cancer at admission and downstaged to cN0 with neoadjuvant systemic treatment were included in the study. All patients were treated with sentinel node biopsy alone without further axillary dissection but followed by regional nodal irradiation.

Of 259 patients, the pathologic complete response rate was 47.1 %. Overall, 171 (66 %) patients had HER2+ and 88 (34 %) had triple-negative cancer. Of 56 ypN+ patients, the lymph node metastases were macrometastases in 24 (42.9 %) patients. After a median follow-up of 46 months, irrespective of ypN status, isolated axillary, locoregional, and distant recurrence rates were 0.8 %, 2.7 %, and 7.7 %, respectively. Recurrence and disease-specific death rates were not different between HER2+ and triple-negative cancer as well as ypN+ and ypN0 patients. Advanced cT stage (cT3-4) was the only significant factor associated with poor disease-free and disease-specific survivals.

Irrespective of the final ypN status and tumor subtype, omission of axillary dissection resulted with low axillary recurrence rate in initially cN+ HER2+ and triple-negative breast cancer patients who were downstaged to cN0 with neoadjuvant systemic treatment and did not receive axillary dissection.

Background/Objectives: This study analyzed real-world data to assess patient characteristics, treatment patterns, and clinical outcomes in patients with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (eBC), as data for this patient group are limited. Methods: This was a retrospective observational cohort study of patients in a US electronic health record-derived deidentified database. Patient characteristics, treatment patterns, and clinical outcomes were analyzed overall and by risk of recurrence (high-risk versus non-high-risk). Results: Of 1290 patients, 366 (28.4%) were classified as high-risk and 924 (71.6%) as non-high-risk. At 5 years, high-risk versus non-high-risk eBC had a lower probability of invasive disease-free survival (72.3% [95% CI: 66.8-77.1%] vs. 80.7% [95% CI: 77.6-83.5%]), distant recurrence-free survival (78.7% [95% CI: 74.1-83.6%] vs. 89.3% [95% CI: 86.9-91.7%]), and overall survival (86.9% [95% CI: 82.3-90.4%] vs. 91.8% [95% CI: 89.4-93.7%]), and a shorter time to mBC diagnosis (22.6 vs. 34.1 months, respectively). Neoadjuvant therapy use increased from 18.2% in 2011-2013 to 67.3% in 2018-2021 in high-risk eBC and from 4.1% to 34.4% in non-high-risk eBC. However, 32.7% of eligible patients with high-risk eBC did not receive neoadjuvant therapy in 2018-2021. Use of post-neoadjuvant and adjuvant therapy increased in high-risk (but not non-high-risk) eBC from 81.8% in 2011-2013 to 91.8% in 2018-2021. Conclusions: High-risk HER2+ eBC manifested more aggressively than non-high-risk eBC. Utilization of neoadjuvant and (post-neo)adjuvant therapy increased over time. However, despite guideline recommendations, uptake of neoadjuvant therapy remains suboptimal.

There are scarce data about the use and benefit of neoadjuvant chemotherapy (NACT) in small size, node-negative triple-negative breast cancer (TNBC). We examined pathological response and survival outcomes of patients with T1N0 TNBC who received NACT.

This is a retrospective cohort study using data from the Surveillance, Epidemiology, and End Results database of patients with T1N0 TNBC diagnosed between 2010 and 2020. Cox regression models were used to compare overall survival (OS) for adjuvant chemotherapy (ACT) and NACT cohorts. Cumulative incidence functions and breast cancer-specific hazard models were used to compare breast cancer specific survival (BCSS) between ACT and NACT cohorts.

We found 8146 patients treated with ACT and 1263 patients treated with NACT. Age < 50 years, mastectomy and radiation therapy were associated with higher odds of receiving NACT. There was no difference in BCSS or OS for patients with T1b/T1cN0 TNBC who received NACT or ACT. However, patients with T1aN0 TNBC had worse BCSS and OS when treated with NACT as compared to those who received ACT. Pathological complete response (pCR) in T1N0 tumors was associated with improved OS (HR, 0.28) and BCSS (HR, 0.21). Furthermore, T1aN0 tumors had lower pCR rate than T1cN0 tumors (18% vs. 47%).

Patients with node-negative, T1b and T1c tumors benefit equally from the use of ACT and NACT. The results of worse outcome in patients with node-negative, T1a tumors treated with NACT compared to ACT are intriguing and need further investigation.

Neoadjuvant chemoimmunotherapy (nCIT) has shown promise in treating early-stage triple-negative breast cancer (eTNBC), but predictive biomarkers for pathological response and prognosis remain poorly defined.

This study aimed to explore pathological complete response and prognostic predictive factors in eTNBC patients treated with nCIT.

We retrospectively analyzed 112 eTNBC patients who underwent surgery after nCIT at Sun Yat-sen University Cancer Center between June 2019 and June 2023. Pathological response was assessed using Miller-Payne grade. Clinicopathological features and hematologic markers were analyzed with univariate and multivariate logistic regression or Cox regression, as well as Kaplan-Meier survival curves. Objective response rate (ORR), pathological complete response (pCR), and disease-free survival (DFS) were evaluated. Nomograms predicting pCR and DFS were constructed based on significant risk factors and the systemic inflammatory response index (SIRI).

Higher baseline lymphocyte counts (P=0.004) were independently associated with a higher pCR rate, while elevated monocyte counts (P=0.006), neutrophil-to-lymphocyte ratio (P=0.005), platelet-to-lymphocyte ratio (p = 0.005), SIRI (P=0.037), systemic immune-inflammation index (P=0.029), and preoperative SIRI (P=0.010) were associated with a lower pCR rate. Higher baseline SIRI (P= 0.009) was correlated with shorter DFS, while higher preoperative lymphocyte counts (P=0.019) predicted longer DFS. Nomograms incorporating SIRI showed high accuracy in predicting pCR and DFS.

Hematologic inflammatory markers, particularly SIRI, are cost-effective and reliable predictors of prognosis and treatment efficacy in eTNBC patients undergoing nCIT, helping clinicians develop personalized treatment strategies.

https://www.medicalresearch.org.cn/, identifier MR-44-24-046099.

Background: Neoadjuvant chemotherapy (NACT) is effective in downstaging locally advanced breast cancer, improving surgical and oncological outcomes. However, luminal B breast cancer typically exhibits a poorer response to NACT, with only 10-15% of patients achieving a pathologic complete response (pCR). This study investigates whether BRCA pathogenic variants (BRCA PVs) influence pCR rates in luminal B breast cancer patients, aiming to identify potential predictors for personalized treatment strategies. Materials and Methods: This retrospective study included luminal B breast cancer patients who underwent NACT at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS between January 2014 and June 2023. Patients were stratified according to BRCA status: BRCA PVs and BRCA wild-type (WT). Primary endpoint was to evaluate pCR rates, while secondary endpoints included locoregional disease-free survival (LR-DFS), distant disease-free survival (DDFS), and overall survival (OS). Results: In total, 495 patients were enrolled, of whom 442 (89.3%) carried BRCA WT and 53 (10.7%) BRCA PVs. The pCR rate was significantly higher in the BRCA PVs group (20.8% PVs vs. 10.9% WT; p = 0.044). Specifically, the breast pCR rate was 28.3% in BRCA PVs versus 15.4% in BRCA WT (p = 0.030). BRCA WT patients had better 5-year LR-DFS (91.1% WT vs. 79.5% PVs; p = 0.003), while no significant differences were observed in 5-year DDFS or OS. Conclusions: BRCA PVs are associated with a higher pCR rate in luminal B breast cancer patients receiving NACT, suggesting a potential predictive role in tailoring treatment strategies.

Little is known regarding biomechanical properties derived from multifrequency MR elastography temporal changes during neoadjuvant chemotherapy (NAC) and associated with pathologic complete response (pCR) and disease-free survival (DFS) in breast cancer. We aimed to investigate temporal changes in NAC-associated biomechanical parameters and assess biomechanical parameters as a predictor of pCR and DFS in breast cancer.

In this prospective longitudinal study, participants with breast cancer who received NAC were enrolled from February 2021 to May 2023. All participants underwent multifrequency MR-elastography at four timepoints: before NAC (T1) and after 2 (T2), 4 (T3), and 6 (T4) cycles. Tomoelastography postprocessing provided biomechanical maps of shear-wave-speed (c) and loss-angle (φ) as proxies of stiffness and viscosity. The biomechanical parameters were validated by means of correlation with histopathologic measurements. Generalized estimating equations were used to compare temporal changes in biomechanical parameters at four time points. Logistic regression was used for pCR analysis and Cox proportional hazards regression was used for survival analysis. Predictive performance was assessed with area under the receiver operating characteristic curve (AUC) analysis.

A total of 235 women (50.6 ± 7.9 years) with 964 scans were enrolled. Biomechanical parameters were supported by positive correlations with pathologic examination-based stroma fraction (c: r =.76, P <.001; φ: r =.49, P =.008) and cellularity (c: r =.58, P =.001; φ: r =.40, P =.035). Progesterone receptor, human epidermal growth factor receptor-2 (HER2), T2-c, and T2-φ were independently associated with pCR (all P <.05). Estrogen receptor, HER2, clinical stage, and change in φ at the early stage of NAC were associated with PFS (all P <.05). The predictive model, which incorporated biomechanical parameters and clinicopathologic characteristics significantly outperformed the clinicopathologic model in predicting pCR (AUC: 0.95, 95% confidence interval [CI]: 0.92, 0.98 vs. 0.79, 95%CI: 0.73, 0.84; P <.001). The predictive model also showed good discrimination ability for DFS (C-index = 0.82, 95%CI: 0.72, 0.90) and stratified prognosis into low-risk and high-risk groups (log-rank, P <.001).

During NAC, patients with higher tumor stiffness and viscosity are less likely to achieve DFS and pCR. The biomechanical parameters exhibit excellent biological interpretability and serve as valuable biomarkers for predicting pCR and DFS in patients with breast cancer.

Accumulating evidence indicates that about 30-40% of patients with HER2-positive early breast cancer might achieve excellent outcomes without chemotherapy. Therefore, we aimed to test the pathological complete response after the addition of pembrolizumab to dual anti-HER2 blockade and omission of chemotherapy in patients with HER2-enriched breast cancer.

WSG-KEYRICHED-1 was a single-arm, multicentre, open-label, hypothesis-generating phase 2 trial done at 15 breast cancer centres in Germany. Women aged 18 years and older, with previously untreated clinical stage T1c-T3, N0-N2, M0, primary unilateral early invasive breast cancer, and locally confirmed HER2 immunohistochemistry score 2+ or 3+ status, and hormone receptor-positive or receptor-negative status, were enrolled. Women with centrally confirmed HER2-enriched subtype by prediction analysis of microarrays 50 gene set (PAM50) and an Eastern Cooperative Oncology Group performance status of 0-1 were allocated to four cycles of intravenous pembrolizumab (200 mg every 3 weeks for 12 weeks), intravenous trastuzumab biosimilar ABP 980 (8 mg/kg loading dose, then 6 mg/kg every 3 weeks for 12 weeks), and intravenous pertuzumab (840 mg loading dose, then 420 mg every 3 weeks for 12 weeks). The primary outcome was the proportion of patients with a pathological complete response (defined as ypN0 or ypT0/is), assessed in the full analysis set, which included all patients who had at least one dose of trial treatment and had central tumour assessment within 3 weeks after the end of trial treatment. For the primary endpoint to be met, at least 52·2% of patients had to have a pathological complete response to support the hypothesis that the proportion of patients with pathological complete response after trial treatment would be higher than 40% with statistical significance. Safety was analysed in all patients who had at least one dose of trial treatment. The study is registered with ClinicalTrials.gov, NCT03988036, and has been completed.

Between Sept 2, 2020, and May 5, 2021, 48 women were enrolled, of whom four did not have surgery, and one had only a local pathological complete response assessment. Therefore, 43 patients with central pathological complete response assessment were included in the full analysis set. Median follow-up was 8·6 months (IQR 8·3-9·0). 20 (47%) of 43 patients had a pathological complete response by central assessment (lower bound of the one-sided 95% CI 33%), thus the null hypothesis (40% pathological complete response) could not be rejected (p=0·22). Four (8%) of 48 patients had grade 3-4 adverse events deemed related to drug treatment. The most common grade 3-4 adverse events were increased alanine aminotransferase (n=1), drug hypersensitivity (n=1), nephritis (n=1), and panic attack (n=1). Serious adverse events occurred in four (8%) of 48 patients, which were drug hypersensitivity (n=1), panic attack (n=1), pyrexia (n=1), and COVID-19 (n=1). Pembrolizumab was discontinued or postponed due to adverse events in three (6%) of 48 patients. No deaths occurred.

Although the null hypothesis could not be rejected, the WSG-KEYRICHED-1 trial highlights the potential of a short chemotherapy-free combination of pembrolizumab with dual anti-HER2 therapy, warranting the initiation of randomised trials investigating the immunotherapy without chemotherapy in patients with HER2-enriched breast cancer.

Merck Sharp & Dohme and NanoString Technologies.

Inflammatory breast cancer (IBC) is a rare, aggressive form of breast cancer. This study evaluates oncologic outcomes in IBC patients treated with modern multimodal treatment.

A retrospective review analyzed clinicopathologic data of 5063 patients, 646 of whom underwent NAC followed by surgery between 2012 and 2024. Survival outcomes were compared across biologic subtypes.

Twenty-six cases of T4dM0 IBC were identified, with 57.7 ​% HER-2 positive, 26.9 ​% ER positive/HER-2 negative, and 15.4 ​% ER negative/HER-2 negative. The total pCR rate was highest in HER-2 positive (53.3 ​%) and lowest in ER-positive/HER-2 negative patients (p ​= ​0.036). Among 19 patients with ≥3 years of follow-up, 47 ​% experienced recurrence (78 ​% distant and 22 ​% locoregional) and 42 ​% died of breast cancer. No significant differences in locoregional recurrence, or survival outcomes were found across subtypes.

pCR has limited prognostic value in IBC. Although HER-2 positive patients are more likely to achieve pCR, this does not necessarily translate into improved outcomes.

Neoadjuvant chemotherapy (NACT) improves surgical outcomes for breast cancer patients, with pathologic complete response (pCR) correlated with enhanced survival. The role of radiomics, particularly from peritumoral tissue, in predicting pCR remains under investigation.

This retrospective study analyzed radiomic features from pretreatment dynamic contrast-enhanced breast MRI scans of 150 patients undergoing NACT. A proportional approach was used to define peritumoral zones, assessed both with a 10% and 30% extension, allowing more standardized assessments relative to the tumor size. Radiomic features were evaluated alongside clinical and biological data to predict pCR. The association of clinical/biological and radiomic features with pCR to NACT was evaluated using univariate and multivariate analysis, logistic regression, and a random forest model. A clinical/biological model, a radiomic model, and a combined clinical/biological and 4 radiomic models for predicting the response to NACT were constructed. Area under the curve (AUC) and 95% confidence intervals (CIs) were used to assess the performance of the models.

Ninety-five patients (average age 47 years) were finally included. HER2 + , basal-like molecular subtypes, and a high level of Ki67 (≥ 20%) were associated with a higher likelihood of pCR to NACT. The combined clinical-biological-radiomic model, especially with a 10% peritumoral extension, showed improved predictive accuracy (AUC 0.76, CI 0.65-0.85) compared to models using clinical-biological data alone (AUC 0.73, CI 0.63-0.83).

Integrating peritumoral radiomic features with clinical and biological data enhances the prediction of pCR to NACT, underscoring the potential of a multifaceted approach in treatment personalization.

This study aims to assess the rate of pathological complete response (pCR) in breast cancer patients undergoing neoadjuvant therapy and to explore its correlation with clinical, molecular, and prognostic factors.

We conducted this retrospective observational study at Liga Contra o Câncer, a major public oncology reference center in Northeast Brazil. We included patients diagnosed with breast cancer who initiated neoadjuvant therapy between June 2018 and June 2019. Patients with a history of recurrent breast cancer or those who did not undergo surgery were excluded. The primary outcome was the pCR rate, with secondary outcomes including Overall Survival (OS), Disease-Free Survival (DFS), mortality, and disease recurrence. Follow-up extended until August 2022. We performed multivariate Cox regression analysis to correlate outcomes with predetermined variables.

Of the 292 included patients, 63 (21.6%) achieved pCR. The mean follow-up duration was 42.8 months. Multivariate logistic regression analysis revealed an association between pCR and the AC-TH regimen [OR = 2.4; 95%CI = 1.13 - 5.24; p=0.023], as well as between pCR and HER2-positive tumors [OR 2.49; 95% CI = 1.14 - 5.86; p=0.028]. Complete pathological response was associated with higher DFS [HR 0.33; 95%CI 0.13-0.86; p=0.024].

Neoadjuvant therapy demonstrated significant efficacy in achieving pathological response in breast cancer patients. We observed a strong association between the AC-TH regimen, HER2-positive status, and pCR.

Response to neoadjuvant treatment in breast cancer has been associated with good oncological outcomes. In Tanzania, a majority of breast cancer patients are diagnosed at stage III; hence, they almost always require neoadjuvant therapy. However, the response to neoadjuvant therapy in these patients remains unknown. This study examined the pathological responses in women with stage III breast cancer who underwent neoadjuvant therapy and identified sociodemographic and clinical predictors of the pathological response in this cohort. This hospital-based retrospective cohort study was conducted between December 2021 and April 2022. It included women with breast cancer who received neoadjuvant therapy and underwent surgery for breast cancer at Muhimbili National Hospital in Tanzania, from January 2018 through December 2021. Data analysis was performed using SPSS version 25. A complete pathological response was identified upon pathological review of the mastectomy specimen. Chi-square tests and Fischer's exact tests were used to evaluate the factors associated with a complete pathological response, with a p value of less than 0.05 indicating statistical significance. Ethical approval was obtained from the Muhimbili University of Health and Allied Sciences Institutional Review Board. The study complied with the Helsinki Declaration on studies involving human subjects. A total of 181 breast cancer patients were recruited for the study, with a mean age of 51±12.6 (28-89) years. A complete pathological response to neoadjuvant therapy was observed in 40 (22.1%) patients which is relatively lower compared to studies from Western countries. Disease stage at diagnosis was associated with response to neoadjuvant therapy, with those at stage IIIA showing better complete response than those at stages IIIB and IIIC indicating a need to improve diagnostic strategies to capture patients in the earlier stages to improve outcomes.

The OXEL study (NCT03487666) was a phase II trial of patients with triple negative breast cancer (TNBC) with residual disease following neoadjuvant chemotherapy, randomized to receive immunotherapy (anti-programmed cell death protein 1, nivolumab), chemotherapy (capecitabine), or chemoimmunotherapy. We previously reported on the primary endpoint of the OXEL trial, demonstrating that a peripheral immunoscore based on circulating immune cells reflecting immune activation was increased in patients treated with immunotherapy. However, compared with cell-based immune assays, sera assays are more cost-effective, less labor-intensive, and samples easier to obtain. Here, we report on differences in serum analytes between treatment arms and associations with clinical response.

Patients (n=38) were assayed for 97 serum analytes before and after 6 and 12 weeks of therapy. Serum analytes were assessed for changes with therapy, and as predictors of disease recurrence and the duration of invasive disease-free survival (iDFS) in both single analyte analyses and machine learning models.

Levels of specific analytes at baseline and changes in levels at early time points on treatment preceding recurrence were associated with eventual development of disease recurrence and/or the duration of iDFS. These associations varied based on the therapy patients received. Immunotherapy led to enrichment in pro-inflammatory analytes following treatment, whereas chemotherapy resulted in overall decreases. Changes seen in patients receiving chemoimmunotherapy more closely resembled those observed in patients receiving immunotherapy alone as opposed to chemotherapy alone. Furthermore, logistic regression and Cox proportional hazard models, developed using machine learning methods, demonstrated that combinations of serum analytes were more predictive of disease recurrence and iDFS duration than analyses of single serum analytes. Notably, the multivariable models that predicted patient outcomes were highly specific to the class of treatment patients received.

In patients with TNBC with residual disease after neoadjuvant chemotherapy, treatment with immunotherapy alone or chemoimmunotherapy resulted in enhanced immune activation compared with chemotherapy alone as measured by changes in serum analyte levels. Distinct serum analytes, both at baseline and as changes after therapy, predicted clinical outcomes for patients receiving immunotherapy alone, chemotherapy alone, or chemoimmunotherapy.

NCT03487666.

Breast Magnetic Resonance Imaging (MRI) demonstrates the highest sensitivity for breast cancer detection among imaging modalities and is standard practice for high-risk women. Interpreting the multi-sequence MRI is time-consuming and prone to subjective variation. We develop a large mixture-of-modality-experts model (MOME) that integrates multiparametric MRI information within a unified structure, leveraging breast MRI scans from 5205 female patients in China for model development and validation. MOME matches four senior radiologists' performance in identifying breast cancer and outperforms a junior radiologist. The model is able to reduce unnecessary biopsies in Breast Imaging-Reporting and Data System (BI-RADS) 4 patients, classify triple-negative breast cancer, and predict pathological complete response to neoadjuvant chemotherapy. MOME further supports inference with missing modalities and provides decision explanations by highlighting lesions and measuring modality contributions. To summarize, MOME exemplifies an accurate and robust multimodal model for noninvasive, personalized management of breast cancer patients via multiparametric MRI.

Breast cancer is one of the most common malignancies among women worldwide. Patients who do not achieve a pathological complete response (pCR) or a clinical complete response (cCR) post-neoadjuvant chemotherapy (NAC) typically have a worse prognosis compared to those who do achieve these responses.

This study aimed to develop and validate a random survival forest (RSF) model to predict survival risk in patients with breast cancer who do not achieve a pCR or cCR post-NAC.

We analyzed patients with no pCR/cCR post-NAC treated at the First Affiliated Hospital of Chongqing Medical University from January 2019 to 2023, with external validation in Duke University and Surveillance, Epidemiology, and End Results (SEER) cohorts. RSF and Cox regression models were compared using the time-dependent area under the curve (AUC), the concordance index (C-index), and risk stratification.

The study cohort included 306 patients with breast cancer, with most aged 40-60 years (204/306, 66.7%). The majority had invasive ductal carcinoma (290/306, 94.8%), with estrogen receptor (ER)+ (182/306, 59.5%), progesterone receptor (PR)- (179/306, 58.5%), and human epidermal growth factor receptor 2 (HER2)+ (94/306, 30.7%) profiles. Most patients presented with T2 (185/306, 60.5%), N1 (142/306, 46.4%), and M0 (295/306, 96.4%) staging (TNM meaning "tumor, node, metastasis"), with 17.6% (54/306) experiencing disease progression during a median follow-up of 25.9 months (IQR 17.2-36.3). External validation using Duke (N=94) and SEER (N=2760) cohorts confirmed consistent patterns in age (40-60 years: 59/94, 63%, vs 1480/2760, 53.6%), HER2+ rates (26/94, 28%, vs 935/2760, 33.9%), and invasive ductal carcinoma prevalence (89/94, 95%, vs 2506/2760, 90.8%). In the internal cohort, the RSF achieved significantly higher time-dependent AUCs compared to Cox regression at 1-year (0.811 vs 0.763), 3-year (0.834 vs 0.783), and 5-year (0.810 vs 0.771) intervals (overall C-index: 0.803, 95% CI 0.747-0.859, vs 0.736, 95% CI 0.673-0.799). External validation confirmed robust generalizability: the Duke cohort showed 1-, 3-, and 5-year AUCs of 0.912, 0.803, and 0.776, respectively, while the SEER cohort maintained consistent performance with AUCs of 0.771, 0.729, and 0.702, respectively. Risk stratification using the RSF identified 25.8% (79/306) high-risk patients and a significantly reduced survival time (P<.001). Notably, the RSF maintained improved net benefits across decision thresholds in decision curve analysis (DCA); similar results were observed in external studies. The RSF model also showed promising performance across different molecular subtypes in all datasets. Based on the RSF predicted scores, patients were stratified into high- and low-risk groups, with notably poorer survival outcomes observed in the high-risk group compared to the low-risk group.

The RSF model, based solely on clinicopathological variables, provides a promising tool for identifying high-risk patients with breast cancer post-NAC. This approach may facilitate personalized treatment strategies and improve patient management in clinical practice.

We developed a practical framework to construct digital twins for predicting and optimizing triple-negative breast cancer (TNBC) response to neoadjuvant chemotherapy (NAC). This study employed 105 TNBC patients from the ARTEMIS trial (NCT02276443, registered on 10/21/2014) who received Adriamycin/Cytoxan (A/C)-Taxol (T). Digital twins were established by calibrating a biology-based mathematical model to patient-specific MRI data, which accurately predicted pathological complete response (pCR) with an AUC of 0.82. We then used each patient's twin to theoretically optimize outcome by identifying their optimal A/C-T schedule from 128 options. The patient-specifically optimized treatment yielded a significant improvement in pCR rate of 20.95-24.76%. Retrospective validation was conducted by virtually treating the twins with AC-T schedules from historical trials and obtaining identical observations on outcomes: bi-weekly A/C-T outperforms tri-weekly A/C-T, and weekly/bi-weekly T outperforms tri-weekly T. This proof-of-principle study demonstrates that our digital twin framework provides a practical methodology to identify patient-specific TNBC treatment schedules.

Pathological complete response (PCR) is the surrogate marker of the outcome of a breast cancer patient. Breast cancer (BC) patients have variable responses to neoadjuvant chemotherapy (NACT). The effect of chemotherapy on mammographic density (MD) is unclear in the literature. Also, MD and PCR correlation is not extensively studied. The aim of the present study is to find MD's potential as a PCR predictor in a resource-constrained setting.

The study included all patients of BC-related surgery from January 2018 to June 2021 with follow-up till June 2023. MD was classified by the American College of Radiology (ACR) (classes A-D) based on breast composition. The chi-square test and logistic regression analysis were used to calculate p-values.

Out of 557 patients, 554 were female with a mean age 46.8 years (premenopausal 54.5%). ACR grades of MD A, B, C, and D were 18.1% (n = 101), 56% (n = 312), 21.5% (n = 120), and 4.3% (n = 24), respectively. The odds of having PCR with MD B, C, and D were 0.51, 0.04, and 0.03, respectively, with respect to MD A. There was a significant inverse association of PCR and Ki-67 with MD on multivariate analysis. HER2 positive, TNBC, Ki 67 > 15%, and grade 3 had significantly high PCR.

MD had an inverse correlation with PCR and Ki-67. Low MD, HER2 positive, TNBC, high Ki-67 subtypes, and grade 3 were good predictors for PCR.

To construct and validate a clinical-radiomics model based on radiomics features extracted from two-stage multimodal ultrasound and clinicopathologic information for early predicting pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC) in breast cancer patients treated with NAC.

Consecutive women with biopsy-proven breast cancer undergoing multimodal US pretreatment and after two cycles of NAC and followed by surgery between January 2014 and November 2023 were retrospectively collected for clinical-radiomics model construction (n = 274) and retrospective test (n = 134). The predictive performance of it was further tested in a subsequent prospective internal test set recruited between January 2024 to July 2024 (n = 76). Finally, a total of 484 patients were enrolled. The clinical-radiomics model predictive performance was compared with radiomics model, clinical model and radiologists' visual assessment by area under the receiver operating characteristic curve (AUC) analysis and DeLong test.

The proposed clinical-radiomics model obtained the AUC values of 0.92 (95%CI: 0.88, 0.94) and 0.85 (95%CI: 0.79, 0.89) in retrospective and prospective test sets, respectively, which were significantly higher than that those of the radiomics model (AUCs: 0.75-0.85), clinical model (AUCs: 0.68-0.72) and radiologists' visual assessments (AUCs:0.59-0.68) (all p < 0.05). In addition, the predictive efficacy of the radiologists was improved under the assistance of the clinical-radiomics model significantly.

The clinical-radiomics model developed in this study, which integrated clinicopathologic information and two-stage multimodal ultrasound features, was able to early predict pCR to NAC in breast cancer patients with favorable predictive effectiveness.

Trastuzumab has significantly improved the treatment of HER2-positive breast cancer, particularly in the neoadjuvant setting, where its combination with chemotherapy increases the pathologic complete response (pCR) rate. This retrospective cohort study assesses the implications of disparities in access to trastuzumab within the Brazilian public healthcare system, focusing on pCR, overall survival (OS) and disease-free survival (DFS) in non-metastatic, HER2-positive breast cancer patients undergoing neoadjuvant chemotherapy (NAC).

The study was conducted in the Hospital Pérola Byington (PEROLA), a public institution, and in the Hospital do Servidor Público Estadual (HSPE), a private institution. pCR was defined as the absence of residual invasive or in situ tumors in the breast and axillary nodes. OS and DFS were calculated by Kaplan-Meier survival analysis for a 5-year period.

From 2011 to 2020, 381 patients at PEROLA and 78 at HSPE underwent NAC. Trastuzumab availability was higher at HSPE (83.4 % vs. 60.0 %, p < 0.0001). Use of trastuzumab correlated with significantly higher pCR rates at both the PEROLA (54.3 % vs. 26.4 %, p < 0.0001) and the HSPE (52.7 % vs. 26.4 %, p < 0.0001). HER2-positive patients with pCR at HSPE also had better OS (80 % vs. 61 %, p < 0.0001) and DFS (89 % vs. 67 %, p < 0.0001) compared to those at PEROLA.

There were significant differences in the provision of trastuzumab between the public and private healthcare systems, adversely affecting clinical outcomes and patient survival. The current data highlight the pressing need to address equity in cancer treatment to improve prognosis for every patient.

There are scant data on patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer treated with neoadjuvant therapy (NAT) in real-world settings with limited access to HER2-targeted therapy.

This was a retrospective analysis of patients with nonmetastatic, HER2-positive breast cancer treated with NAT between January 2014 and December 2018 to determine factors affecting pathologic complete response (pCR), event-free survival (EFS), and overall survival (OS).

The cohort comprised 1,004 patients with a median age of 47 years, 533 (53.1%) with clinical T3/T4 tumors, 466 (46.4%) with clinical N2/3 status, and 527 (52.5%) with hormone receptor-positive disease. Trastuzumab was given to 528 (52.6%) patients in the neoadjuvant setting and 711 (70.8%) patients in neoadjuvant and/or postoperative settings. pCR was achieved in 226 (22.5%) patients; the 5-year EFS in the whole cohort, pCR group, and no-pCR group was 63.5% (95% CI, 60.36 to 66.63), 86.1% (95% CI, 81.59 to 90.60), and 57% ([95% CI, 53.47 to 60.52]; P < .001), respectively. In multivariable analysis in the full cohort, smaller tumor size (cT1/T2 v cT3/T4), higher grade (III v II), hormone receptor-negative status, and use of neoadjuvant HER2-targeted therapy were significantly associated with higher pCR, and smaller tumor size (cT1/T2 v cT3/T4), lower node involvement (cN0/N1 v cN2/N3), achievement of pCR, and receiving trastuzumab were significantly associated with higher EFS and OS.

In a setting with constrained access to HER2-targeted therapy, lower clinical tumor burden and receiving trastuzumab were significantly associated with increased pCR and survival in patients with HER2-positive breast cancer treated with NAT. Efforts should be made to enhance early diagnosis and access to HER2-targeted therapy worldwide.

Background Intratumoral heterogeneity (ITH) in breast cancer contributes to treatment failure and relapse. Noninvasive methods to quantify ITH are currently limited. Purpose To quantify ITH in breast cancer using pretreatment MRI, develop a nomogram to predict pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC) and recurrence-free survival (RFS), and investigate biologic pathways associated with nomogram scores. Materials and Methods This retrospective study included patients with breast cancer who underwent NAC at nine centers between April 1988 and December 2023. Tumor regions on MRI scans were clustered and integrated with global pixel distribution patterns to calculate ITH scores. A nomogram for predicting pCR was developed using multivariable logistic regression. A survival dataset was used to evaluate the association between nomogram score and RFS, and a genomics dataset was used to explore the relationship between nomogram score and biologic pathways. Results The study included 1448 women (median age, 49 years [IQR, 43-54 years]). To predict pCR to NAC, the 505 patients from center A served as the training set, and the patients from center B, centers C-F, and center G served as three external validation sets (n = 331, 107, and 384, respectively). The survival set included patients from centers A and H (n = 179), and the genomics set included patients from center I (n = 74). The ITH score was an independent predictor of pCR (odds ratio, 0.12 [95% CI: 0.03, 0.43]; P < .001). The nomogram model achieved area under the receiver operating characteristic curve values of 0.82, 0.81, and 0.79, respectively, in the three external validation sets. A lower nomogram score was correlated with poorer RFS (hazard ratio, 4.04 [95% CI: 1.90, 8.60]; P < .001) and was associated with upregulation of biologic pathways related to tumor proliferation. Conclusion A nomogram model combining ITH score and clinicopathologic variables showed good performance in predicting pCR to NAC and RFS. Published under a CC BY 4.0 license. Supplemental material is available for this article.

Pathological complete response (pCR) has been proven to be related to prognosis. pCR can be further classified as pCR of the breast (bpCR), pCR of axillary lymph nodes (apCR) or pCR of both tumors. The aim of this study was to elucidate the outcomes and clinicopathological characteristics associated with different patterns of pCR.

Patients with node-positive disease who received neoadjuvant chemotherapy between August 2009 and July 2016 and who achieved pCR in axillary lymph nodes, breast or both were included. Multivariate logistic regression was used to identify factors related to different patterns of pCR.

Among the 271 patients who were included in the study, 42.1% achieved total pCR, 46.1% achieved ApCR, and 11.8% achieved BpCR. Disease-free survival (DFS) was significantly better in the total pCR group than in the limited pCR groups throughout the entire cohort (p = 0.042). Univariate and multivariate analyses indicated that patients with HR-negative disease and a high Ki-67 proliferation index were more likely to achieve total pCR. Patients with earlier T stage disease were more likely to achieve pCR only in the breast. Among patients who achieved limited pCR, there was no significant difference in terms of whether these patients received intensified adjuvant chemotherapy.

Total pCR is still the best marker for predicting survival benefit in patients receiving neoadjuvant chemotherapy, and total pCR is more likely to be achieved in patients with HR-negative disease and a high Ki-67 proliferation index. T stage and N stage may predict apCR and bpCR, respectively.

The apelinergic system exerts multiple biological activities in human pathologies, including cancer. Overactivation of apelin/APJ, which has been detected in many malignant tumors, and the strong correlation with progression-free and overall survival, suggested the role of an oncogene for the apelin gene. Emerging evidence sheds new light on the effects of apelin on cellular functions and homeostasis in cancer cells and supports a direct role for this pathway on different hallmarks of cancer: "sustaining proliferative signaling", "resisting cell death", "activating invasion and metastasis", "inducing/accessing vasculature", "reprogramming cellular metabolism", "avoiding immune destruction" and "tumor-promoting inflammation", and "enabling replicative immortality". This article reviews the currently available literature on the intracellular processes regulated by apelin/APJ, focusing on those pathways correlated with tumor development and progression. Furthermore, the association between the activity of the apelinergic axis and the resistance of cancer cells to oncologic treatments (chemotherapy, immunotherapy, radiation) suggests apelin/APJ as a possible target to potentiate traditional therapies, as well as to develop diagnostic and prognostic applications. This issue will be also covered in the review.

Neoadjuvant therapy for breast cancer improves the prognosis of high-risk patients. However, whether pathological completed response (pCR) can be used as a surrogate endpoint for de-escalation therapy in patients who are relatively sensitive to treatment remains to be elucidated.

We retrospectively reviewed 143 breast cancer patients, with clinical stage (cStage) II-IIIA who received neoadjuvant chemotherapy and achieved pCR in a short time (within 16 weeks) from 2012 to 2022. The prognosis of patients was analysed using the Kaplan-Meier method, Cox proportional hazards regression models to identify independent clinicopathologic factors affecting prognosis.

The median follow-up period was 47 months, the overall 4-year disease-free survival (DFS) and overall survival (OS) were 95.3% and 96.9%, respectively, in 143 patients with pCR after neoadjuvant chemotherapy. The 4-year DFS between the postoperative adjuvant chemotherapy and no adjuvant chemotherapy groups was 76.4% and 95.2%, with a significant statistical difference between both groups (P < 0.05). For HER2-positive (HER2+) and Triple negative breast cancer (TNBC), the addition of targeted therapy or platinum-based drugs had no impact on prognosis. Univariate and multivariate analyses of prognosis showed that only postoperative adjuvant chemotherapy significantly affected prognosis.

Patients with operable cStage II-IIIA breast cancer who achieved pCR after a short period of neoadjuvant chemotherapy have a satisfactory prognosis and may be suitable for chemotherapy "de-escalation." This approach is also a dominant application of neoadjuvant "tailoring therapy."