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A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone

Cabozantinib will be taken orally once a day in cycles of 28 days (4 weeks). Fulvestrant
will be given intramuscularly on days 1 and 15 of cycle 1 and on day 1 of all subsequent

On Day 1 of each cycle subjects will have the following tests and procedures:

- Performance status

- Physical exam

- Vital signs

- Routine blood samples

- Blood and urine samples to look at bone markers (Cycle 1 through 6 only)

Subjects will also have the following additional tests and procedures:

- Tumor assessment by CT scan and bone scan at Cycle 3, then every 12 weeks

- Blood or urine pregnancy test (if applicable) on Day 1 of Cycles 1, 2, 4, then every 12

- Urine sample and blood test for thyroid function (Cycle 1, 3, 5, then every 6 weeks)

- Blood test for breast cancer tumor marker (Cycle 1 and 4, then every 6 weeks)

- Pain questionnaire and painkiller medication diary at 7-day intervals during Week 3,
Week 6, and every 6 weeks thereafter.

Inclusion Criteria:

- Clear evidence of metastases to bone on isotope bone scan

- Histologically or cytologically confirmed metastatic Estrogen-receptor-positive (ER+)
and/or Progesterone-receptor-positive (PR+) and HER2 negative breast cancer

- Received at least one prior line of hormonal or chemo-therapy for metastatic disease

- must be post menopausal

- Recovered from toxicities related to prior treatment, except alopecia, lymphopenia,
or other non-clinically significant Adverse Events (AEs)

- Life expectancy > 3 months

- Adequate organ and marrow function

- Sexually active fertile subjects and their partners must agree to use medically
accepted methods of contraception

- Able to lie flat for up to 45 minutes for imaging studies

- Able to swallow capsules or tablets

Exclusion Criteria:

- Pregnant or breast-feeding

- Has experienced clinically-significant hematemesis or hemoptysis of > 0.5 teaspoons
of red blood, or other signs indicative of pulmonary hemorrhage within 3 months
before the first dose of study treatment

- Untreated, symptomatic or uncontrolled brain metastasis requiring current treatment
including steroids and anti-convulsants

- more than 1 prior line of chemotherapy for treatment of metastatic breast cancer

- prior treatment with fulvestrant

- Requires concomitant treatment, in therapeutic doses, with anticoagulants such as
warfarin or coumadin-related agents, thrombin or FXa inhibitors, and antiplatelet
agents (eg, clopidogrel)

- Uncontrolled or significant intercurrent illness

- Gastrointestinal disorders, particularly those associated with a high risk of
perforation or fistula formation

- Active infection requiring systemic treatment

- Serious non-healing wound/ulcer/bone fracture

- History of organ transplant

- Concurrent uncompensated hypothyroidism or thyroid dysfunction

- Previously-identified allergy or hypersensitivity to components of the study
treatment formulation

- Diagnosis of another malignancy, requiring systemic treatment, within the last 2
years, unless non-melanoma skin cancer, in-situ carcinoma of the cervix, or
superficial bladder cancer

Type of Study:


Study Design:

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

Outcome Measure:

Bone Scan Response Rate

Outcome Description:

To evaluate the bone scan response rate in patients with hormone-receptor-positive breast cancer with bone metastases receiving cabozantinib. Bone scan response rate will be defined as the percentage of patients experiencing a complete resolution or significant improvement in the bone scan.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Michaela J Higgins, MD, MRCPI

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • ER+
  • PR+
  • HER2-
  • metastatic
  • Breast Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana Farber Cancer InstituteBoston, Massachusetts  02115