Cabozantinib for Metastatic Triple Negative BrCa



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2013
End Date:October 2014

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

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.

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.

Inclusion Criteria:

- Histologically or cytologically confirmed invasive breast cancer with stage IV
disease

- Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative

- May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer.
Must be off treatment for at least 21 days prior to enrollment

- Must have discontinued all biologic therapy at least 14 days before enrollment

- May have received prior radiation therapy in the early stage or metastatic setting,
but must have completed treatment at least 14 days prior to enrollment

- Must agree to use medically acceptable methods of contraception

- Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue

- Able to swallow tablets

Exclusion Criteria:

- Pregnant or breastfeeding

- Received another investigational agent within 14 days prior to enrollment

- Received prior c-Met inhibitor

- Known brain metastases that are untreated, symptomatic or require therapy to control
symptoms

- Psychiatric illness or social situation that could limit ability to comply with study
requirements

- Require concomitant treatment in therapeutic doses with anticoagulants or
antiplatelet agents

- Diagnosis of another malignancy requiring systemic treatment within the last two
years (except non-melanoma skin cancer or in-situ carcinoma of the cervix)

- Known to be positive for HIV

- Active infection requiring IV antibiotics at Day 1 of cycle 1

- Uncontrolled, significant intercurrent illness

- Requires chronic concomitant treatment of a strong CYP3A4 inducer

- tumor in contact with, invading or encasing major blood vessels

- Have experienced clinically significant gastrointestinal bleeding within 6 months,
hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs
indicative of pulmonary hemorrhage within 3 months of enrollment
We found this trial at
3
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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