OncoMatch/Clinical Trials/NCT06797635
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Is NCT06797635 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast neoplasms.
Treatment: Patritumab deruxtecan · Pembrolizumab · Paclitaxel · Carboplatin · Doxorubicin hydrochloride · Epirubicin hydrochloride · Cyclophosphamide · Capecitabine · Olaparib — Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn: * About the safety of the study treatments and if people tolerate them * If people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 low expression (HR-low+)
HR-low+/HER2- breast cancer
Required: HER2 (ERBB2) negative (HER2-)
HR-low+/HER2- breast cancer
Required: ESR1 negative (triple-negative)
triple-negative
Required: PR (PGR) negative (triple-negative)
triple-negative
Required: HER2 (ERBB2) negative (triple-negative)
triple-negative
Disease stage
Excluded: Stage IV
locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Cannot have received: anti-HER3 antibody
Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody
Cannot have received: antibody-drug conjugate (exatecan derivative that is a topoisomerase I inhibitor, trastuzumab deruxtecan)
Has received prior treatment with...antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan)
Cannot have received: radiation therapy
Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
Cannot have received: systemic therapy
Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
Cannot have received: definitive surgery
Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
Lab requirements
Cardiac function
LVEF ≥50% or ≥ lower limit of normal (LLN) as assessed by ECHO or MUGA scan
Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Hematology/Oncology - Parkside ( Site 0021) · Santa Monica, California
- Orchard Healthcare Research Inc. ( Site 0006) · Skokie, Illinois
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003) · Billings, Montana
- Northwest Cancer Specialists (Compass Oncology) ( Site 8003) · Tigard, Oregon
- SCRI Oncology Partners ( Site 7000) · Nashville, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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