OncoMatch/Clinical Trials/NCT05020860
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
Is NCT05020860 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast cancer.
Treatment: Paclitaxel · Carboplatin · Trastuzumab · Pertuzumab · Doxorubicin · Cyclophosphamide · Pembrolizumab · Pertuzumab/Trastuzumab/Hyaluronidase-zzxf — The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Allowed: HER2 (ERBB2) positive
HER2-positive (as defined by ASCO-CAP guidelines)
Allowed: ESR1 positive
high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines). To be considered "high risk," at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score < 6; 4) Ki-67 ≥ 30%.
Disease stage
Excluded: Stage IV
Definitive clinical or radiologic evidence of Stage IV disease [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anthracycline
Prior treatment with anthracyclines for any malignancy.
Cannot have received: endocrine therapy
Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.
Cannot have received: chemotherapy
Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.
Cannot have received: targeted therapy
Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.
Cannot have received: radiation therapy
Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.
Lab requirements
Blood counts
ANC ≥ 1200/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ institutional ULN
Liver function
Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome; Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN; AST/ALT ≤ 1.5 x institutional ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or MUGA scan
Adequate organ function, as determined by the following parameters: Absolute Neutrophil Count (ANC) ≥ 1200/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL; Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome; Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN; Serum creatinine ≤ institutional ULN. Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Harris Health System - Smith Clinic · Houston, Texas
- O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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