drugset / Trial / NCT05020860

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

NCT05020860

Phase 2 Recruiting 185 enrolled Baylor Breast Care Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-04-18
Primary completion
2027-08
Completion
2029-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 1.5 unknown Intravenous
Comparator Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Comparator Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 80 mg/m2 Intravenous
Comparator Pembrolizumab Monoclonal antibody 200 mg Intravenous
Comparator Pembrolizumab Monoclonal antibody 400 mg Intravenous
Comparator Pertuzumab Monoclonal antibody 420 mg Intravenous
Comparator Pertuzumab/Trastuzumab/Hyaluronidase-zzxf Unknown 600 mg Subcutaneous
Comparator Pertuzumab/Trastuzumab/Hyaluronidase-zzxf Unknown 20000 iu Subcutaneous
Comparator Trastuzumab Monoclonal antibody 6 mg/kg Intravenous