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

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.

Conditions

• Breast Cancer
• Breast Neoplasm
• Breast Cancer Female
• Breast Cancer Invasive
• Breast Cancer Stage II
• Breast Cancer Stage III
• Triple Negative Breast Cancer
• Hormone Receptor-positive Breast Cancer
• HER2-positive Breast Cancer
• Triple Negative Breast Neoplasms
• Estrogen Receptor-positive Breast Cancer

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.

Sponsors & Collaborators

• Baylor Breast Care Center

  lead OTHER

Principal Investigators

• Mothaffar Rimawi, MD · Baylor College of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-18

Primary Completion

2027-08-31

Completion

2029-11-30

FDA Drug

Yes

Countries

• United States

Study Locations