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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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To determine whether prostate-specific antigen (PSA) could serve as a biomarker for breast cancer.
- A thorough gross examination of specimens for breast cancer requires the tissue to be very thinly sectioned, which is often difficult in large mastectomy samples. We have implemented rapid chilling ...
Deregulated Notch signaling due to mutation or overexpression of ligands and/or receptors is implicated in various human malignancies. Gamma-secretase inhibitors inhibit Notch signaling by preventing ...
There are currently no targeted therapies approved for triple-negative breast cancer (TNBC). A tumor necrosis factor α ( TNFα)-based gene expression signature (GS) predictive of sensitivity to LCL16...
γ-Secretase complex, the assembly of nicastrin (NCT), Presenilin (PS), Presenilin Enhancer-2 (PEN-2) and Anterior pharynx defective 1 (Aph-1), catalyzes the cleavage of amyloid precursor protein to g...
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.
Integral membrane proteins and essential components of the gamma-secretase complex that catalyzes the cleavage of membrane proteins such as NOTCH RECEPTORS and AMYLOID BETA-PROTEIN precursors. Mutations of presenilins lead to presenile ALZHEIMER DISEASE with onset before age 65 years.
Endopeptidases that are specific for AMYLOID PROTEIN PRECURSOR. Three secretase subtypes referred to as alpha, beta, and gamma have been identified based upon the region of amyloid protein precursor they cleave.
An analogue of GAMMA-AMINOBUTYRIC ACID. It is an irreversible inhibitor of 4-AMINOBUTYRATE TRANSAMINASE, the enzyme responsible for the catabolism of GAMMA-AMINOBUTYRIC ACID. (From Martindale The Extra Pharmacopoeia, 31st ed)
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Track and monitor developments in breast cancer research and commercial development. Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...