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Rishabh Jain: A-BRAVE Lesson – A “Negative” Trial Shifts the Conversation

Rishabh Jain/X

Sep 2, 2025, 16:54

Rishabh Jain: A-BRAVE Lesson – A “Negative” Trial Shifts the Conversation

Rishabh Jain, Medical Oncologist at AIIMS, shared a post on X about a paper by P.F. Conte et al. published in Annals of Oncology:

“A-BRAVE lesson: Even a ‘negative’ trial can bravely shift the conversation

Trial essentials

Phase 3 | N=466 | High-risk early TNBC post chemo + surgery

Arms:

Avelumab (1 year)
Observation

Primary endpoint (DFS, co-primary ITT, and Stratum B):

No significant improvement

ITT HR 0.81 (95% CI: 0.61–1.09, p=0.17)
Stratum B HR 0.80 (95% CI: 0.58–1.10, p=0.17)

Secondary endpoint (OS, descriptive):

HR 0.66 (95% CI: 0.45–0.97)
3-yr OS: 84.8% vs 76.3%

PD-L1: Prognostic, not predictive

Safety:

Well tolerated
Grade ≥3 irAEs rare (<5%)
Most common: thyroid dysfunction (all G1–2)

Take-home:

Formally negative for DFS, but OS and DDFS show hypothesis-generating signals.

Future trials (e.g., SWOG S1418) will clarify adjuvant ICI’s role.”

Rishabh Jain: A-BRAVE Lesson - A "Negative" Trial Shifts the Conversation

Title: A-BRAVE trial: a Phase 3 randomized trial with anti-PD-L1 avelumab in high-risk triple-negative early breast cancer patients

Authors: P.F. Conte, M.V. Dieci, G. Bisagni, P. Schmid, A. Zambelli, F. Piacentini, M. De Laurentiis, A.G. Favaretto, S. Tamberi, G.V. Bianchi, C. Zamagni, S. Cinieri, D.C. Corsi, L. Del Mastro, A. Ferro, A. Gennari, M. Mion, A. Musolino, L. Nicolé, P. Del Bianco, G.L. De Salvo, V. Guarneri

You can read the Full Article in Annals of Oncology.

Rishabh Jain: A-BRAVE Lesson - A "Negative" Trial Shifts the Conversation