Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer HER2-, HR+ post-menopausal Locally advanced or metastatic Breast Cancer (HER2-, HR+)
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 97
Healthy volunteers: no

Brief summary:
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy.

Patients must undergo molecular pre-screening prior to entry.

Detailed description:

Arms:
arm 1: Fulvestrant in combination with the study drug Dovitinib. arm 2: Fulvestrant in combination with a placebo matching Dovitinib.

Interventions: intervention 1: Dovitinib intervention 2: Fulvestrant intervention 3: Dovitinib Placebo
Intervention descriptions: intervention 1: Active Dovitinib (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule intervention 2: Fulvestrant (in solution) injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week. intervention 3: Dovitinib Placebo (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule

Protocol document: