Pathologic Complete Response (pCR) Rate and Predictors of Response to Taxane, Trastuzumab, and Pertuzumab in HER2‑Positive Breast Cancer: Secondary Analyses of EA1181/CompassHER2 pCR

PURPOSE: EA1181 (ClinicalTrials.gov identifier: NCT04266249) is a single-arm trial evaluating neoadjuvant taxane, trastuzumab, and pertuzumab (THP) in patients with clinical stage II/IIIa human epidermal growth factor receptor 2 (HER2)-positive breast cancer. This report focuses on the secondary end points of pathologic complete response (pCR) rates and associated factors. The primary end point-3-year recurrence-free survival among patients achieving a pCR (ypT0/Tis, ypN0)-will be reported when data mature. METHODS: Patients received four cycles of trastuzumab and pertuzumab (HP) with either once per week paclitaxel (12 weeks) or docetaxel (every 3 weeks for four cycles), followed by surgery. Clinicopathologic characteristics were assessed in all patients. The HER2DX pCR score was determined using diagnostic biopsy samples in a representative subset. Logistic regression models identified factors associated with pCR. RESULTS: A total of 2,175 patients were enrolled (781 HER2+/estrogen receptor‑negative [ER-]; 1,394 HER2+/ER+). Of 2,141 patients who initiated THP, the overall pCR rate was 43.8%: 63.7% in HER2+/ER- and 32.4% in HER2+/ER+ tumors. Higher pCR rates were observed in tumors that were ER-negative or low ER expressing, progesterone receptor-negative or low expressing, HER2 immunohistochemistry (IHC) 3+, and in patients treated with once per week paclitaxel. T3 disease was associated with a lower pCR rate in HER2+/ER- tumors; otherwise, tumor (T) and nodal (N) stage did not significantly affect pCR. Among 569 patients assessed for HER2DX pCR scores, a high score was independently associated with higher pCR rates, after adjustment for clinicopathologic variables. CONCLUSION: Neoadjuvant THP achieved pCR in nearly two-thirds of patients with HER2+/ER- and one third with HER2+/ER+ breast cancer. Low hormone receptor expression, HER2 IHC 3+ status, once per week paclitaxel use, and a high HER2DX pCR score were independent predictors of pCR. These findings should help optimize risk stratification and treatment personalization for patients with HER2-positive breast cancer.

Authors

Institutions

Publication Details

Journal
Journal of Clinical Oncology
Published
2026-08-20
DOI
https://doi.org/10.1200/jco-25-02255
Primary Topic
HER2/EGFR in Cancer Research
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Pathologic Complete Response (pCR) Rate and Predictors of Response to Taxane, Trastuzumab, and Pertuzumab in HER2‑Positive Breast Cancer: Secondary Analyses of EA1181/CompassHER2 pCR

Shou‐Ching Tang, Virginia F. Borges, Angela M. DeMichele, Sunil Badve et al.
Journal of Clinical Oncology
HER2/EGFR in Cancer Research
article

Pathologic Complete Response (pCR) Rate and Predictors of Response to Taxane, Trastuzumab, and Pertuzumab in HER2‑Positive Breast Cancer: Secondary Analyses of EA1181/CompassHER2 pCR

Shou‐Ching Tang, Virginia F. Borges, Angela M. DeMichele, Sunil Badve, Jean L. Wright, Nina D’Abreo, Abram Recht, Antonio C. Wolff, Anna C. Weiss, Mary Lou Smith, Amy Krie, Shanu Modi, Fengmin Zhao, Ann H. Partridge, Nadine Tung, Lisa A. Carey, Melinda L. Telli, Ciara C. O’Sullivan, Nisha G Unni, Olga Martínez‐Sáez, Nusayba Ali Bagegni, Kathy D. Miller, Eric P. Winer, Payal D. Shah, Patricia Villagrasa, Chiara Battelli, Gabrielle Betty Rocque, W. J. Irvin, Mridula A. George, Judy A. Tjoe, Sheldon M. Feldman, Sagar D. Sardesai
article en

Abstract

PURPOSE: EA1181 (ClinicalTrials.gov identifier: NCT04266249) is a single-arm trial evaluating neoadjuvant taxane, trastuzumab, and pertuzumab (THP) in patients with clinical stage II/IIIa human epidermal growth factor receptor 2 (HER2)-positive breast cancer. This report focuses on the secondary end points of pathologic complete response (pCR) rates and associated factors. The primary end point-3-year recurrence-free survival among patients achieving a pCR (ypT0/Tis, ypN0)-will be reported when data mature. METHODS: Patients received four cycles of trastuzumab and pertuzumab (HP) with either once per week paclitaxel (12 weeks) or docetaxel (every 3 weeks for four cycles), followed by surgery. Clinicopathologic characteristics were assessed in all patients. The HER2DX pCR score was determined using diagnostic biopsy samples in a representative subset. Logistic regression models identified factors associated with pCR. RESULTS: A total of 2,175 patients were enrolled (781 HER2+/estrogen receptor‑negative [ER-]; 1,394 HER2+/ER+). Of 2,141 patients who initiated THP, the overall pCR rate was 43.8%: 63.7% in HER2+/ER- and 32.4% in HER2+/ER+ tumors. Higher pCR rates were observed in tumors that were ER-negative or low ER expressing, progesterone receptor-negative or low expressing, HER2 immunohistochemistry (IHC) 3+, and in patients treated with once per week paclitaxel. T3 disease was associated with a lower pCR rate in HER2+/ER- tumors; otherwise, tumor (T) and nodal (N) stage did not significantly affect pCR. Among 569 patients assessed for HER2DX pCR scores, a high score was independently associated with higher pCR rates, after adjustment for clinicopathologic variables. CONCLUSION: Neoadjuvant THP achieved pCR in nearly two-thirds of patients with HER2+/ER- and one third with HER2+/ER+ breast cancer. Low hormone receptor expression, HER2 IHC 3+ status, once per week paclitaxel use, and a high HER2DX pCR score were independent predictors of pCR. These findings should help optimize risk stratification and treatment personalization for patients with HER2-positive breast cancer.

Journal of Clinical Oncology
Rutgers, The State University of New Jersey (US), University of North Carolina at Chapel Hill (US), Indiana University Health (US), University of Wisconsin–Green Bay (US), Albert Einstein College of Medicine (US), Beth Israel Deaconess Medical Center (US), Allina Health (US), Memorial Sloan Kettering Cancer Center (US), Montefiore Medical Center (US), Harvard University (US), Emory University (US), Breast Cancer Research Foundation (US), Washington University in St. Louis (US), The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (US), Yale Cancer Center (US), University of Alabama at Birmingham (US), NYU Langone Health (US), New England Cancer Specialists (US), ECOG-ACRIN Cancer Research Group (US), Southeast Clinical Oncology Research Consortium (US), Dana-Farber Cancer Institute (US), Mayo Clinic in Arizona (US), Oryzon Genomics (Spain) (ES), Louisiana Cancer Research Center (US), Research Advocacy Network (US), Sidney Kimmel Comprehensive Cancer Center (US), Rutgers Cancer Institute (US), UNC Lineberger Comprehensive Cancer Center, University of Colorado Anschutz Medical Campus (US), University of Rochester (US), Indiana University – Purdue University Indianapolis (US), University of Pennsylvania (US), The University of Texas Southwestern Medical Center (US), Stanford University (US)
Good health and well-being
Openalex Percentile: Top 13%
HER2/EGFR in Cancer Research
DOISourceOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.