Cabozantinib for Metastatic Triple Negative BrCa
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|ClinicalTrials.gov Identifier: NCT01738438|
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : July 7, 2016
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Cabozantinib||Phase 2|
* To evaluate the activity of cabozantinib, as defined by objective response rate in patients with triple-negative metastatic breast cancer
- To evaluate progression free survival
- To evaluate c-Met and phospho c-Met expression in archival tumor tissue
- To evaluate the incidence of c-Met amplified circulating tumor cells at baseline
- To evaluate potential plasma biomarkers of cabozantinib
This study uses a two-stage design enrolling 35 patients to evaluate efficacy of cabozantinib based on overall response defined as complete or partial response per RECIST1.1 criteria. The null and alternative overall response rates were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=13 patients) achieve PR or better then accrual proceeds to stage two (n=22 patients).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of XL184 (Cabozantinib) for Metastatic Triple-Negative Breast Cancer|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
Other Name: XL184
- Objective Response Rate [ Time Frame: Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17). ]The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST1.1 criteria. For target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Confirmatory scans were required 3 weeks following initial documentation.
- Progression Free Survival [ Time Frame: Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17). ]Progression-free survival (PFS) estimated using Kaplan-Meier methods was defined as the time from registration to documented disease progression (PD) or death. Based on RECIST1.1, radiographic PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning therapy, the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients who were event-free were censored at the date of their last disease evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738438
|United States, Massachusetts|
|Dana-Farber Cancer Institute at Faulkner Hospital|
|Boston, Massachusetts, United States, 02130|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02214|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Sara Tolaney, MD, MPH||Dana-Farber Cancer Institute|