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Proposal 1293

Title of the Proposed Research

INCIDENCE OF BRAIN METASTASES IN METASTATIC BREAST CANCER PATIENTS RECEIVING PALLIATIVE CHEMOTHERAPY WITH OR WITHOUT BEVACIZUMAB: A METAANYLSIS OF FIVE PROSPECTIVE RANDOMIZED PHASE III TRIALS

Lead Researcher

Rupert Bartsch

Affiliation

Medical University of Vienna, Comprehensive Cancer Center Vienna

Funding Source

Funding for this study is provided by the research budget of the Medical University of Vienna.

Potential Conflicts of Interest

Honoraria, travel and research support from Roche Austria.

Data Sharing Agreement Date

11 March 2016

Lay Summary

A growing incidence of breast cancer brain metastases (BM) was repeatedly observed during the last decade. High morbidity, reduced quality of life due to neurological symptoms and clinically relevant late-toxicity of whole brain radiotherapy lead to growing interest in systemic therapy for treatment and prevention of BM. While lapatinib plus capecitabine or trastuzumab-emtansine showed activity in Her2-positive BM, currently no “BM-specific” systemic treatment is available in triple-negative and luminal breast cancer subtypes. Therefore, preventive strategies are of major importance.

In lung cancer, treatment including bevacizumab, a humanized monoclonal antibody targeting VEGF-A, was associated with a lower rate of BM; these results are strengthened by experimental data: in a preclinical model, anti-VEGF treatment prevented metastatic outgrowth to the brain.

In metastatic breast cancer, activity of bevacizumab was investigated in several studies and the drug is currently licensed in Europe for first-line treatment of Her2-negative metastatic disease in combination with paclitaxel or capecitabine.

Here, we propose an analysis investigating the rate of BM in five phase III trials comparing bevacizumab plus chemotherapy to chemotherapy alone. We hypothesize that bevacizumab containing therapy results in lower rate of BM and prolonged brain metastases-free survival.

Study Data Provided

Study ROCHE-AVF2119G: A multicenter, open-label, phase III, randomized, active-controlled trial evaluating the efficacy, safety, and pharmacokinetics of rhuMAb VEGF (bevacizumab), in combination with capecitabine chemotherapy, in subjects with previously treated metastatic breast cancer
Study ROCHE-BO17708: A randomized, double-blind study of the effect of first line treatment with Avastin (bevacizumab) in combination with docetaxel on progression-free survival and disease response in patients with HER2 negative metastatic breast cancer
Study ROCHE-AVF3694G: A multicenter, phase III, randomized, placebo-controlled trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy regimens in subjects with previously untreated metastatic breast cancer
Study ROCHE-BO20231: A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.
Study ROCHE-AVF3693G: A Phase III, Multicenter, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Treated Metastatic Breast Cancer

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.