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Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01441947
First Posted: September 28, 2011
Last Update Posted: July 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Exelixis
Information provided by (Responsible Party):
Steven Isakoff, MD, PhD, Massachusetts General Hospital
September 22, 2011
September 28, 2011
July 27, 2017
October 2011
June 2019   (Final data collection date for primary outcome measure)
Bone Scan Response Rate [ Time Frame: 2 years ]
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.
Same as current
Complete list of historical versions of study NCT01441947 on ClinicalTrials.gov Archive Site
  • Overall Response Rate [ Time Frame: 2 years ]
    To evaluate overall response rate (ORR) (defined as the percentage of patients experiencing a complete response or partial response)
  • Overall Survival [ Time Frame: 2 years ]
    To evaluate Overall Survival
  • Progression Free Survival [ Time Frame: 2 years ]
    To evaluate Progression Free Survival
  • Effects on bone and tumor markers [ Time Frame: 2 years ]
    To evaluate the effects of cabozantinib on biochemical markers of bone turnover and tumor markers
  • Skeletal related event rates (includes analgesic usage, incidence of fractures, need for radiation or surgical intervention and pain at sites of bone disease) [ Time Frame: 2 years ]
    All intercurrent adverse events, treatments and interventions will be recorded. For the purpose of determining the effects of cabozantinib treatment on pain and analgesic medication usage, pain will be assessed by a participant-reported questionnaire, and daily analgesic medication usage will be recorded during regular intervals.
  • Fluorodeoxyglucose Positron Emission Tomography(FDG-PET) Response Rate [ Time Frame: 2 years ]
    To evaluate FDG-PET response rate
  • Overall Response Rate [ Time Frame: 2 years ]
    To evaluate overall response rate (ORR) (defined as the percentage of patients experiencing a complete response or partial response)
  • Overall Survival [ Time Frame: 2 years ]
    To evaluate Overall Survival
  • Progression Free Survival [ Time Frame: 2 years ]
    To evaluate Progression Free Survival
  • Effects on bone and tumor markers [ Time Frame: 2 years ]
    To evaluate the effects of cabozantinib on biochemical markers of bone turnover and tumor markers
  • Skeletal related event rates (includes analgesic usage, incidence of fractures, need for radiation or surgical intervention and pain at sites of bone disease) [ Time Frame: 2 years ]
    All intercurrent adverse events, treatments and interventions will be recorded. For the purpose of determining the effects of cabozantinib treatment on pain and analgesic medication usage, pain will be assessed by a participant-reported questionnaire, and daily analgesic medication usage will be recorded during regular intervals.
  • FDG-PET (Flurodeoxyglucose Positron Emission Tomography) Response Rate [ Time Frame: 2 years ]
    To evaluate FDG-PET response rate
Not Provided
Not Provided
 
Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer
A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone

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.

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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Cabozantinib
    Part of combination arm
    Other Name: XL184
  • Drug: Fulvestrant
    part of combination arm
    Other Name: Faslodex
Experimental: Cabozantinib plus fulvestrant
Combination therapy with cabozantinib 60 mg daily plus fulvestrant 500 mg monthly Intramuscularly (IM)
Interventions:
  • Drug: Cabozantinib
  • Drug: Fulvestrant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
68
December 2020
June 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01441947
11-208
Yes
Not Provided
Plan to Share IPD: No
Steven Isakoff, MD, PhD, Massachusetts General Hospital
Massachusetts General Hospital
Exelixis
Principal Investigator: Steven J Isakoff, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP