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RATIONALE: RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- To assess the antitumor activity of gamma-secretase inhibitor RO4929097 in patients with advanced, metastatic, and/or recurrent triple-negative breast cancer through the co-primary endpoints of overall response rate using RECIST and 6-month progression-free survival (PFS).
- To assess the antitumor activity of gamma-secretase inhibitor RO4929097 through secondary endpoints, including duration of radiologic response, PFS rate, and overall survival rate.
- To assess the safety and tolerability of gamma-secretase inhibitor RO4929097 in patients with breast cancer.
- To explore the expression of Notch biomarkers in triple-negative breast cancer and potential interaction with gamma-secretase inhibitor RO4929097 response and toxicity. (exploratory)
- To evaluate the downstream effects of gamma-secretase inhibitor RO4929097 in patients with advanced triple-negative breast cancer. (exploratory)
OUTLINE: This is a multicenter study.
Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo biopsy at baseline and at 4-5 weeks and blood samples are collected periodically for correlative laboratory studies.
After completion of study treatment, patients are followed up monthly for 12 months and then every 3 months thereafter.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
gamma-secretase inhibitor RO4929097, laboratory biomarker analysis
Tom Baker Cancer Centre - Calgary
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:12:37-0400
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A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.
Integral membrane protein of Golgi and endoplasmic reticulum. Its homodimer is an essential component of the gamma-secretase complex that catalyzes the cleavage of membrane proteins such as NOTCH RECEPTORS and AMYLOID BETA-PROTEIN precursors. PSEN2 mutations cause ALZHEIMER DISEASE type 4.
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