OncRef

Clinical Trial: NCT02926196

Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Istituto Oncologico Veneto IRCCS
Information Provided By:Istituto Oncologico Veneto IRCCS
Last Update Posted:2025-12-12

Study Overview

Brief Summary

Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall protocol-defined patient population will include the following two strata of patients:

  • Stratum A - Patients who have completed treatment with curative intent including surgery of the primary tumor followed by adjuvant chemotherapy .
  • Stratum B - Patients who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated) further adjuvant chemotherapy.

Official Title

Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab: A Phase III Randomized Trial. Sponsor: Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, Università di Padova

Conditions

Triple Negative Breast Neoplasms

Intervention / Treatment

  • Drug: MSB0010718C

Other Study ID Numbers

  • A-BRAVE-Trial
  • 2016-000189-45
  • 2016

Start Date (Actual)

2016-06-17

Primary Completion Date (Actual)

2024-06

Study Completion Date (Actual)

2025-10-09

Enrollment (Actual)

474

Study Type

Interventional

Phase

Phase 3