Study Summary
This study is evaluating whether cabozantinib in combination with fulvestrant is more effective than cabozantinib alone for treatment of hormone-receptor-positive breast cancer that has spread to bone.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 2 years
2 years
Bone Scan Response Rate
Effects on bone and tumor markers
Overall Response Rate
Overall Survival
Progression Free Survival
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Cabozantinib plus fulvestrant
1 of 1
Experimental Treatment
68 Total Participants · 1 Treatment Group
Primary Treatment: Cabozantinib plus fulvestrant · No Placebo Group · Phase 2
Cabozantinib plus fulvestrantExperimental Group · 2 Interventions: Cabozantinib, Fulvestrant · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Fulvestrant
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
ExelixisIndustry Sponsor
109 Previous Clinical Trials
17,940 Total Patients Enrolled
3 Trials studying Breast Cancer
54 Patients Enrolled for Breast Cancer
Massachusetts General HospitalLead Sponsor
2,699 Previous Clinical Trials
30,843,064 Total Patients Enrolled
78 Trials studying Breast Cancer
125,450 Patients Enrolled for Breast Cancer
Steven J Isakoff, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Xu J, Higgins MJ, Tolaney SM, Come SE, Smith MR, Fornier M, Mahmood U, Baselga J, Yeap BY, Chabner BA, Isakoff SJ. A Phase II Trial of Cabozantinib in Hormone Receptor-Positive Breast Cancer with Bone Metastases. Oncologist. 2020 Aug;25(8):652-660. doi: 10.1634/theoncologist.2020-0127. Epub 2020 Jun 18.
- Steven J Isakoff, MD, PhD 2011. "Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01441947.
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Conditions
Cancer Related
Treatments