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Tyrosine Kinase Inhibitor
Cabozantinib + Fulvestrant for Metastatic Hormone-Receptor-Positive Breast Cancer
Phase 2
Waitlist Available
Led By Steven J Isakoff, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Summary
This trialtests a drug that blocks proteins involved in breast cancer growth, spread, and blood vessel formation. It may help stop cancer growth.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bone Scan Response Rate
Secondary study objectives
Overall Response Rate
Overall Survival
Progression Free Survival
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cabozantinib plus fulvestrantExperimental Treatment2 Interventions
Combination therapy with cabozantinib 60 mg daily plus fulvestrant 500 mg monthly Intramuscularly (IM)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Fulvestrant
FDA approved
Find a Location
Who is running the clinical trial?
ExelixisIndustry Sponsor
120 Previous Clinical Trials
20,062 Total Patients Enrolled
3 Trials studying Breast Cancer
54 Patients Enrolled for Breast Cancer
Massachusetts General HospitalLead Sponsor
3,014 Previous Clinical Trials
13,309,263 Total Patients Enrolled
79 Trials studying Breast Cancer
131,103 Patients Enrolled for Breast Cancer
Steven J Isakoff, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 3 more months.You are currently taking blood thinners or medications that prevent blood clotting.Your organs and bone marrow are working properly.You have received an organ transplant in the past.You have already tried more than one type of chemotherapy for metastatic breast cancer treatment.You have received treatment with fulvestrant in the past.You have a severe wound, ulcer, or bone fracture that is not healing properly.You have had an allergic reaction or are hypersensitive to any of the ingredients in the study treatment.You have already received at least one round of hormone therapy or chemotherapy for your advanced disease.You have brain metastasis (cancer spread to the brain) that is causing symptoms and needs treatment, including medication to reduce swelling and prevent seizures.You have severe digestive system problems that could lead to holes or abnormal connections in your organs.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib plus fulvestrant
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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