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

PHASE2RecruitingINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

April 18, 2023

Primary Completion Date

August 31, 2027

Study Completion Date

November 30, 2029

Conditions
Breast CancerBreast NeoplasmBreast Cancer FemaleBreast Cancer InvasiveBreast Cancer Stage IIBreast Cancer Stage IIITriple Negative Breast CancerHormone Receptor-positive Breast CancerHER2-positive Breast CancerTriple Negative Breast NeoplasmsEstrogen 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.

Trial Locations (2)

77054

RECRUITING

Harris Health System - Smith Clinic, Houston

RECRUITING

O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center, Houston

All Listed Sponsors
lead

Baylor Breast Care Center

OTHER