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RECRUITING
NCT05020860
PHASE2

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

Sponsor: Baylor Breast Care Center

View on ClinicalTrials.gov

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

Interventions

DRUG

Paclitaxel

80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle

DRUG

Carboplatin

Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle

DRUG

Trastuzumab

Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle

DRUG

Pertuzumab

Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle

DRUG

Doxorubicin

60 mg/m2 IV administered on Day 1 of each 14-day cycle

DRUG

Cyclophosphamide

600 mg/m2 IV administered on Day 1 of each 14-day cycle

DRUG

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.

DRUG

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