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

Breast Cancer Clinical Trial

Official title: A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT01441947
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 2011
• Completion date: December 2023