Bevacizumab, Etoposide and Cisplatin Followed by Whole Brain Radiotherapy in Breast Cancer With Brain Metastases

Summary

The primary objective of A-PLUS trial is to evaluate and compare the efficacy of induction BEEP (bevacizumab preconditioning followed by etoposide and cisplatin) followed by whole bran radiotherapy (WBRT) with WBRT alone in the controlling of brain metastases (BM) in metastatic breast cancer (MBC) patients who have not previously received WBRT. In past 2 years, the research team has demonstrated that BEEP regimen is a highly effective treatment for brain metastases of breast cancer progressing from WBRT by a multi-center phase II study (ClinicalTrials.gov Identifier: NCT01281696). The basic concept of preconditioning, as referred to starting bevacizumab 1 day before chemotherapy, is that the effect of bevacizumab induced tumor vascular normalization takes time to mature. The investigators hypothesized that as induction BEEP decreased the size of brain tumors, the effectiveness of WBRT would be maximized. The investigators expect this integrated approach will do greater benefit to MBC patients with BM, irrespective of subtype.

Timeline

Start

2014-04-21

Primary completion

2019-11-01

Completion

2022-11

Outcome

Missed primary endpoint

paper hazard ratio, 0.71; 95% CI, 0.44-1.13; P = .15 PMID 38127335 ↗

Publications

• Chen TW, Dai MS, Tseng LM, Chen SC, Chao TY, Chao TC, Chang YC, Chiu CF, Liu CT, Lin CH, Liu CY, Chen YF, Chang DY, Yu JC, Rau KM, Hsieh YY, Shen SC, Huang SM, Cheng AL, Lu YS. Whole-Brain Radiotherapy Alone vs Preceded by Bevacizumab, Etoposide, and Cisplatin for Untreated Brain Metastases From Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2024 Mar 1;10(3):325-334. doi: 10.1001/jamaoncol.2023.5456.

Drugs

Indications