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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT01441947
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Given orally daily with a starting dose of 40 mg
  • Fulvestrant — DRUG
    Given intramuscularly 500 mg on Days 1 and 15 of the first 28 day cycle, then on Day 1 only each cycle after

Study Details

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.

Key Dates

Start date
Oct 31, 2011
Status verified
May 2025
Primary completion
Dec 12, 2016
Completion
Aug 9, 2019

Study Design

Enrollment
68 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib
    Oral cabozantinib therapy daily
  • Experimental: Cabozantinib plus fulvestrant
    Combination therapy with oral cabozantinib daily plus fulvestrant monthly Intramuscularly (IM)

Primary Outcome Measure

Bone Scan Response Rate [ Time Frame: 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02214-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Beth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NY

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