Impact of Neoadjuvant Immunotherapy in Early Stage Breast Cancer Before Standard Therapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

February 24, 2022

Primary Completion Date

February 28, 2025

Study Completion Date

February 28, 2026

Conditions
Breast Cancer
Interventions
DRUG

Atezolizumab Injection

Patients randomized to an atezolizumab arm will receive atezolizumab 840 mg IV on D1 (15 days +/- 48 h before the surgery date or the biopsy prior to the start of standard of care neoadjuvant systemic treatment.).

DRUG

Bevacizumab

Patients in the atezolizumab plus bevacizumab arm will receive a unique dose of bevacizumab as 10 mg/kg administered by IV infusion over 60 mins on day 1 cycle 1 (15 days before surgery +/- 48 h), the same day as atezolizumab.

DRUG

Pertuzumab

Patients in the atezolizumab plus trastuzumab plus pertuzumab arm will receive single doses of pertuzumab on day 1 administered IV. Pertuzumab will be administered IV at a loading dose of 840 mg.

DRUG

Trastuzumab

Patients in the atezolizumab plus trastuzumab plus pertuzumab arm will receive single doses of Trastuzumab on day 1 administered IV. Trastuzumab will be given at a loading dose of 8 mg/kg.

Trial Locations (1)

94800

RECRUITING

Gustave Roussy, Villejuif

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER