Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Oct 28;32(11):603.
doi: 10.3390/curroncol32110603.

Predictors of Pathologic Complete Response and Its Prognostic Value in Early Breast Cancer: A Real-World Cohort Study

Selami Bayram  1 , Ali Murat Tatli  1 , Muharrem Okan Cakir  2 , Mustafa Ozdogan  1
Affiliations

Predictors of Pathologic Complete Response and Its Prognostic Value in Early Breast Cancer: A Real-World Cohort Study

Selami Bayram et al. Curr Oncol. .

Abstract

Background: Pathologic complete response (pCR) after neoadjuvant systemic therapy (NAST) is a key prognostic marker in early breast cancer (EBC), particularly in triple-negative (TNBC) and HER2-positive subtypes. However, real-world data on predictors of pCR and their impact on survival remain limited.

Methods: We retrospectively analyzed 200 patients with stage II-III EBC treated with NAST at a single institution (2015-2023). Clinicopathologic variables and treatment characteristics were evaluated for association with pCR (ypT0/is ypN0), and histological regression was additionally assessed using the Miller-Payne scoring system. Multivariable logistic regression identified independent predictors. Disease-free survival (DFS) and overall survival (OS) were estimated using Kaplan-Meier methods.

Results: Overall, 36.0% achieved pCR, with the highest rates in HER2-positive (65%) and TNBC (56%) subtypes. Independent predictors of pCR included HER2 positivity (OR 4.21, 95% CI 1.83-9.67, p < 0.001), high Ki-67 > 47.5% (OR 3.62, 95% CI 1.68-7.80, p = 0.001), ER < 10% (OR 2.77, 95% CI 1.18-6.50, p = 0.019), and radiologic complete response (OR 10.03, 95% CI 2.91-34.60, p < 0.001). At a median follow-up of 75 months, compared with non-pCR, patients achieving pCR had a significantly lower risk of recurrence (HR 0.16, 95% CI 0.04-0.70, p = 0.014) with 5-year DFS rates of 91.5% vs. 72.8%. For OS, pCR patients showed a lower risk of death (HR 0.33, 95% CI 0.07-1.49, p = 0.150), corresponding to 5-year OS of 92.2% vs. 87.0%, although this difference was not statistically significant.

Conclusions: HER2 positivity, high Ki-67, low ER expression, and radiologic complete response are independent predictors of pCR. Achieving pCR strongly correlates with improved DFS but not OS, likely due to limited sample size and event number. These findings reinforce pCR as a surrogate endpoint in TNBC and HER2-positive disease and highlight the need for post-neoadjuvant escalation in non-pCR patients.

Keywords: HER2-positive breast cancer; breast neoplasms; disease-free survival; early breast cancer; neoadjuvant therapy; pathologic complete response; predictive biomarkers; prognosis; triple-negative breast cancer.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
Receiver operating characteristic (ROC) curve of Ki-67 for prediction of pathologic complete response (pCR). AUC = 0.667 (95% CI 0.587–0.748; p < 0.001 by DeLong test). The optimal cut-off by Youden’s index was 47.5%, with sensitivity 0.82 and specificity 0.46. The diagonal line indicates no discrimination (AUC = 0.5).
Figure 2
Figure 2
Kaplan–Meier curves of disease-free survival (DFS) according to pathologic complete response (pCR) status.
Figure 3
Figure 3
Kaplan–Meier curves of overall survival (OS) according to pathologic complete response (pCR) status.
See this image and copyright information in PMC

References

    1. Loibl S., André F., Bachelot T., Barrios C., Bergh J., Burstein H., Cardoso M., Carey L., Dawood S., Del Mastro L., et al. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann. Oncol. 2024;35:159–182. doi: 10.1016/j.annonc.2023.11.016. - DOI - PubMed
    1. Korde L.A., Somerfield M.R., Carey L.A., Crews J.R., Denduluri N., Hwang E.S., Khan S.A., Loibl S., Morris E.A., Perez A., et al. Neoadjuvant Chemotherapy, Endocrine Therapy, and Targeted Therapy for Breast Cancer: ASCO Guideline. J. Clin. Oncol. 2021;39:1485–1505. doi: 10.1200/JCO.20.03399. - DOI - PMC - PubMed
    1. Cortazar P., Zhang L., Untch M., Mehta K., Costantino J.P., Wolmark N., Bonnefoi H., Cameron D., Gianni L., Valagussa P., et al. Pathological complete response and long-term clinical benefit in breast cancer: The CTNeoBC pooled analysis. Lancet. 2014;384:164–172. doi: 10.1016/S0140-6736(13)62422-8. - DOI - PubMed
    1. Spring L.M., Fell G., Arfe A., Sharma C., Greenup R., Reynolds K.L., Smith B.L., Alexander B., Moy B., Isakoff S.J., et al. Pathologic Complete Response after Neoadjuvant Chemotherapy and Impact on Breast Cancer Recurrence and Survival: A Comprehensive Meta-analysis. Clin. Cancer Res. 2020;26:2838–2848. doi: 10.1158/1078-0432.CCR-19-3492. - DOI - PMC - PubMed
    1. Masuda N., Lee S.-J., Ohtani S., Im Y.-H., Lee E.-S., Yokota I., Kuroi K., Im S.-A., Park B.-W., Kim S.-B., et al. Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. N. Engl. J. Med. 2017;376:2147–2159. doi: 10.1056/NEJMoa1612645. - DOI - PubMed

Substances