Description:
The study drug cabozantinib works by inhibiting several different proteins which are believed
to be involved in breast cancer tumor growth, its ability to spread, and its ability to form
new blood vessels. This drug has been used in other research studies and information from
those other research studies suggests that this drug may help to prevent cancer growth.
The single agent portion of this study is now closed to accrual. This research study is now
examining the efficacy of cabozantinib in combination with fulvestrant for treatment of
hormone-receptor-positive breast cancer that has spread to bone.
Title
- Brief Title: Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer
- Official Title: A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone
Clinical Trial IDs
- ORG STUDY ID:
11-208
- NCT ID:
NCT01441947
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Cabozantinib | XL184 | Cabozantinib plus fulvestrant |
Fulvestrant | Faslodex | Cabozantinib plus fulvestrant |
Purpose
The study drug cabozantinib works by inhibiting several different proteins which are believed
to be involved in breast cancer tumor growth, its ability to spread, and its ability to form
new blood vessels. This drug has been used in other research studies and information from
those other research studies suggests that this drug may help to prevent cancer growth.
The single agent portion of this study is now closed to accrual. This research study is now
examining the efficacy of cabozantinib in combination with fulvestrant for treatment of
hormone-receptor-positive breast cancer that has spread to bone.
Detailed Description
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 cycles.
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 Computed Tomography (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
weeks
- 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.
Trial Arms
Name | Type | Description | Interventions |
---|
Cabozantinib plus fulvestrant | Experimental | Combination therapy with cabozantinib 60 mg daily plus fulvestrant 500 mg monthly Intramuscularly (IM) | |
Eligibility Criteria
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 Human Epidermal Growth Factor Receptor
(HER) 2 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 Factor Xa 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Bone Scan Response Rate |
Time Frame: | 2 years |
Safety Issue: | |
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. |
Secondary Outcome Measures
Measure: | Overall Response Rate |
Time Frame: | 2 years |
Safety Issue: | |
Description: | To evaluate overall response rate (ORR) (defined as the percentage of patients experiencing a complete response or partial response) |
Measure: | Overall Survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | To evaluate Overall Survival |
Measure: | Progression Free Survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | To evaluate Progression Free Survival |
Measure: | Effects on bone and tumor markers |
Time Frame: | 2 years |
Safety Issue: | |
Description: | To evaluate the effects of cabozantinib on biochemical markers of bone turnover and tumor markers |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Massachusetts General Hospital |
Trial Keywords
- ER+
- PR+
- Human Epidermal Growth Factor Receptor (HER) 2 negative
- metastatic
Last Updated
May 10, 2021