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Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
Sponsor: Baylor Breast Care Center
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.
Official title: A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
185
Start Date
2023-04-18
Completion Date
2029-11
Last Updated
2025-02-27
Healthy Volunteers
No
Conditions
Interventions
Paclitaxel
80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle
Carboplatin
Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle
Trastuzumab
Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle
Pertuzumab
Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle
Doxorubicin
60 mg/m2 IV administered on Day 1 of each 14-day cycle
Cyclophosphamide
600 mg/m2 IV administered on Day 1 of each 14-day cycle
Pembrolizumab
Either 200 mg IV administered on Day 1 of Cycles 1-4, or 400 mg IV administered on Day 1 of Cycles 1 and 3 of the paclitaxel/carboplatin regimen. 400 mg on Day 1 of Cycles 1 and 4 of the dose-dense AC regimen.
Pertuzumab/Trastuzumab/Hyaluronidase-zzxf
Can be used in place of separate IV formulations of pertuzumab and trastuzumab. 1200 mg pertuzumab/600 mg trastuzumab/30,000 U hyaluronidase administered subcutaneously on Day 1 of the first cycle, followed by a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab/20,000 U hyaluronidase administered subcutaneously every 3 weeks.
Locations (2)
Harris Health System - Smith Clinic
Houston, Texas, United States
O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States