Lead Investigator: Phillip Garfin, Seattle Genetics Inc.
Title of Proposal Research: Effectiveness of cytotoxic chemotherapy for the treatment metastatic breast cancer subtypes
Vivli Data Request: 5813
Funding Source: None
Potential Conflicts of Interest: Dr. Garfin is a full-time employees of Seattle Genetics and a holder of equity in the company. These relationships will be managed by full disclosure during the project and at any disclosures of the results.
Summary of the Proposed Research:
Breast cancer is one of the most common cancers worldwide. According to the American Cancer Society, breast cancer affects more than 250,00 women in the United States each year (DeSantis 2019). Although substantial progress has been made in the treatment of breast cancer, metastatic breast cancer (cancer which has spread to other parts of the body) is still a major cause of death. For example, 42,000 women in the united states die each year from breast cancer (Siegel 2019). There are several different types of breast cancer. These types of breast cancer can be described by the proteins found on the cancer cells, namely the estrogen receptor, progesterone receptor and HER2/neu protein. Breast cancers that have the estrogen receptor and/or progesterone receptor are known as hormone receptor positive (HR+) breast cancer. HR+ breast cancers rely upon the hormones that bind the hormone receptors to promote growth and spread of the cancer. These cancers can be treated by therapies that lower estrogen levels in the body or block the actions of estrogens. Tumors that respond to these therapies are called hormone responsive. Tumors that no longer respond to these therapies are called hormone refractory.
For patients with metastatic HR+ positive breast cancer, anti-estrogen therapies can control the cancer for several years. Eventually the cancer will eventually stop responding to these treatments and become hormone refractory. Hormone refractory breast cancer is treated with traditional chemotherapy. Although numerous studies have been conducted in metastatic breast cancer, the effect of chemotherapy on hormone refractory HR+ breast cancer, especially as it compares to chemotherapy for other subtypes of advanced breast cancer, has not been well described.
Seattle Genetics currently is developing drugs that have the potential to treat various subtypes of breast cancer, including HR+ disease. In order to develop drugs that make a meaningful improvement over current treatments, it is important to determine a benchmark on the efficacy of current treatment options. Seattle Genetics proposes to use data from ClinicalStudyDataRequest.com to understand how effective chemotherapy is for treating HR+ disease and to compare these results to those for other breast cancer subtypes. This research will also exploratory to identify other clinically significant patient characteristics that could impact on treatment outcomes.
Requested Studies:
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
Sponsor: Roche
Study ID: NCT00109239
Sponsor ID: AVF2119g
Docetaxel in Comparison With Docetaxel Plus Placebo, as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer
Sponsor: Roche
Study ID: NCT00333775
Sponsor ID: BO17708
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
Sponsor: Roche
Study ID: NCT00262067
Sponsor ID: AVF3694g
Trial to Evaluate Safety and Efficacy of rhuMAb VEGF as Monotherapy in Subjects with Hormone Refractory Breast Cancer
Sponsor: Roche
Sponsor ID: AVF0776G
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
Sponsor: Roche
Study ID: NCT01663727
Sponsor ID: GO25632
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
Sponsor: Roche
Study ID: NCT00281697
Sponsor ID: AVF3693g
Update: This data request was withdrawn on 22 December 2020 by the researcher.