A–BRAVE-Trial. ADJUVANT TREATMENT FOR HIGH-RISK TRIPLE NEGATIVE BREAST CANCER PATIENTS WITH THE ANTI-PD-L1 ANTIBODY AVELUMAB: A PHASE III RANDOMIZED TRIAL

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514515-10-00

Acronym

A-BRAVE-Trial

Enrollment

450

Registered

2024-11-25

Start date

2016-06-16

Completion date

2025-10-09

Last updated

2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

Disease-free survival (DFS): DFS will be calculated as the time interval between randomization and any of the following events, whichever first: local, regional and distant recurrence; second primary breast cancer, excluding in situ carcinoma; other second primary cancer (excluding in-situ cancers); death before recurrence or second primary cancer.

Detailed description

OS will be evaluated as secondary efficacy endpoint. The survival will be calculated as the timeinterval between randomization and patient death or last follow-up.

Interventions

DRUGBavencio 20 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease-free survival (DFS): DFS will be calculated as the time interval between randomization and any of the following events, whichever first: local, regional and distant recurrence; second primary breast cancer, excluding in situ carcinoma; other second primary cancer (excluding in-situ cancers); death before recurrence or second primary cancer.	—

Secondary

Measure	Time frame
OS will be evaluated as secondary efficacy endpoint. The survival will be calculated as the timeinterval between randomization and patient death or last follow-up.	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026