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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
Steven Isakoff, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01441947
First received: September 22, 2011
Last updated: November 10, 2014
Last verified: November 2014

September 22, 2011
November 10, 2014
October 2011
December 2015   (final data collection date for primary outcome measure)
Bone Scan Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate Overall Survival
  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate Progression Free Survival
  • Effects on bone and tumor markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate FDG-PET response rate
Same as current
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 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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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.
 
Recruiting
50
December 2016
December 2015   (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 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
Both
18 Years and older
No
Contact: Steven J Isakoff, MD, PhD 617-726-4920 sisakoff@partners.org
United States
 
NCT01441947
11-208
Yes
Steven Isakoff, MD, PhD, Massachusetts General Hospital
Massachusetts General Hospital
Exelixis
Principal Investigator: Steven J Isakoff, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
November 2014

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