Cabozantinib for Metastatic Triple Negative BrCa

Breast Cancer Clinical Trial

Official title: A Phase II Study of XL184 (Cabozantinib) for Metastatic Triple-Negative Breast Cancer

Status Completed

Clinical Trial Summary

This research study is Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA has not yet approved XL184 for use in patients, including people with your type of cancer.

XL184 is a drug that may stop cancer cells from growing. It is a small molecule kinase inhibitor that inhibitors met and VEGFR2, as well as other targets. This drug has been used in Phase I studies in humans and laboratory experiments, and information from those other research studies suggests that this drug may help to slow tumor progression in this research study. This drug has also been used in a phase II study for breast cancer patients (a randomized discontinuation trial) suggesting good benefit for this group of patients.

In this research study, we are looking at the anti-tumor effects of XL184 in metastatic breast cancer.

Clinical Trial Description

In order to determine if you are eligible to participate in this study you will need to undergo some tests and procedures. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests and procedures recently, they may or may not have to be repeated. These tests and procedures include a medical history, physical exam, performance status, assessment of your tumor, blood tests, a urine test and a pregnancy test (if applicable). If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.

If you take part in this research study, you will be given a one month supply of XL184 and a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 3 weeks during which time you will be taking the study drug once per day by mouth.

During all cycles you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.

The investigators will assess your tumor by CT scan or MRI after 6 weeks of treatment, and then every nine weeks you remain on treatment.

The investigators will try to obtain samples of your tumor tissue from a biopsy if you have had one previously. A new biopsy is optional, but may provide researchers with additional information about how XL184 affects the tumor cells.

Participants will receive a pain questionnaire along with information on how to fill in the questionnaire.

The investigators would like to keep track of your medical condition for the rest of your life. The investigators would like to do this by calling you on the telephone once every 6 months to see how you are doing. Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT01738438
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: Phase 2
• Start date: February 2013
• Completion date: October 2014