Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

362

Participants

Timeline

Start Date

April 26, 2016

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2025

Conditions
Radiation Therapy, Breast Cancer, Sequential Partial Breast IrradiationIntermediate and High-risk Luminal and Triple Negative Breast Cancer
Interventions
RADIATION

Accelerated partial breast irradiation

To date, there is no report on external beam APBI associated with CT in the neoadjuvant setting.In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI.

DRUG

Chemotherapy

minimum of six cycles of PST using anthracycline and/or taxane based regimens

Trial Locations (6)

38043

RECRUITING

CHU de Grenoble, Grenoble

Unknown

RECRUITING

CHI Créteil, Créteil

RECRUITING

AP-HP Henri mondor, Paris

RECRUITING

CHU Avicenne, Paris

RECRUITING

H. Hartmann Institute of Radiotherapy and Radiosurgery, Paris

RECRUITING

Tenon hospital, Paris

All Listed Sponsors
lead

University Hospital, Grenoble

OTHER

NCT02806258 - Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone | Biotech Hunter | Biotech Hunter