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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
  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.


Condition Intervention Phase
Breast Cancer Drug: Cabozantinib Drug: Fulvestrant Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone

Resource links provided by NLM:


Further study details as provided by Steven Isakoff, MD, PhD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 68
Study Start Date: October 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabozantinib plus fulvestrant
Combination therapy with cabozantinib 60 mg daily plus fulvestrant 500 mg monthly Intramuscularly (IM)
Drug: Cabozantinib
Part of combination arm
Other Name: XL184
Drug: Fulvestrant
part of combination arm
Other Name: Faslodex

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441947


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Massachusetts General Hospital
Exelixis
Investigators
Principal Investigator: Steven J Isakoff, MD, PhD Massachusetts General Hospital
  More Information

Responsible Party: Steven Isakoff, MD, PhD, Principal Investigator, Attending Physician in Medical Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01441947     History of Changes
Other Study ID Numbers: 11-208
First Submitted: September 22, 2011
First Posted: September 28, 2011
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Steven Isakoff, MD, PhD, Massachusetts General Hospital:
ER+
PR+
Human Epidermal Growth Factor Receptor (HER) 2 negative
metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists