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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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

- 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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Evaluation of XL184 based on objective response rate

Outcome Description:

To evaluate the activity of XL184, as defined by objective response rate (ORR) in patients with triple-negative metastatic breast cancer

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Sara Tolaney, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastatic
  • Triple Negative
  • Stage IV
  • Breast Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana-Farber Cancer Institute at Faulkner HospitalBoston, Massachusetts  02215