Tivantinib in Treating Patients With Recurrent or Metastatic Breast Cancer
This phase II trial studies how well tivantinib works in treating patients with recurrent or metastatic breast cancer. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Estrogen Receptor-negative Breast Cancer
HER2-negative Breast Cancer
Progesterone Receptor-negative Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Triple-negative Breast Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of ARQ 197 in Metastatic Triple-negative Breast Cancer|
- PFS status [ Time Frame: Time from start of treatment to time of progression or death, assessed up to 6 months ] [ Designated as safety issue: No ]Analyzed using the Kaplan-Meier method. 95% confidence intervals (CI) will be determined.
- Overall response using RECIST v1.1 [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]The 95% confidence intervals should be provided.
- Toxicity as assessed by NCI CTCAE v4.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2012|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (tivantinib)
Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.
Other Name: ARQ 197Other: laboratory biomarker analysis
I. To evaluate the activity of tivantinib (ARQ-197) as defined by 6-month progression-free survival (PFS) of participants with triple-negative metastatic breast cancer.
I. To evaluate objective response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
II. To evaluate c-Met and phospho c-Met expression in archival tumor tissue. (Exploratory) III. To evaluate the incidence of c-Met-positive circulating tumor cells at baseline. (Exploratory) IV. To evaluate the effect of ARQ-197 on serum markers relevant to c-Met pathway (hepatocyte growth factor [HGF] and vascular endothelial growth factor [VEGF]). (Exploratory) V. To evaluate phosphatase and tensin homolog (PTEN) loss and PI3K mutations in archival tumor tissue. (Exploratory) VI. To evaluate proportion of participants with basal-like breast cancer. (Exploratory)
OUTLINE: This is a multicenter study.
Patients receive tivantinib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC). Archived tumor tissue samples are also analyzed.
After completion of study treatment, patients are followed up every 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575522
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Boston, Massachusetts, United States, 02130|
|Principal Investigator:||Sara Tolaney||Dana-Farber Cancer Institute|