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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
Proposal
1293
Title of 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
[{ "PostingID": 1308, "Title": "ROCHE-AVF2119G", "Description": "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
Medicine: bevacizumab, Condition: refractory metastatic breast cancer, Phase: 3, Clinical Study ID: AVF2119G, Sponsor: Roche" },{ "PostingID": 1309, "Title": "ROCHE-BO17708", "Description": "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
Medicine: bevacizumab, Condition: malignant neoplasm of breast, Phase: 3, Clinical Study ID: BO17708, Sponsor: Roche" },{ "PostingID": 1310, "Title": "ROCHE-AVF3694G", "Description": "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
Medicine: bevacizumab, Condition: malignant neoplasm breast unspecified site, Phase: 3, Clinical Study ID: AVF3694G, Sponsor: Roche" },{ "PostingID": 2547, "Title": "ROCHE-BO20231", "Description": "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.
Medicine: Bevacizumab, Condition: malignant neoplasm of breast, Phase: 3, Clinical Study ID: BO20231, Sponsor: Roche" },{ "PostingID": 2549, "Title": "ROCHE-AVF3693G", "Description": "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
Medicine: Bevacizumab, Condition: malignant neoplasm of breast, Phase: 3, Clinical Study ID: AVF3693G, Sponsor: Roche" }]
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.
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