Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer

• Status: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Estradiol; Fulvestrant

Criteria

Inclusion Criteria:

• Postmenopausal women with HER2-, HR+ locally advanced or metastatic breast cancer

• Progression on or after endocrine treatment

• Measureable disease as per RECIST

• ECOG 0, 1 or 2

Exclusion Criteria:

• Evidence of CNS or leptomeningeal metastases

• Previous treatment with fulvestrant

• Previous chemotherapy for locally advanced or metastatic breast cancer

• Cirrhosis or chronic active/persistent hepatitis

Other protocol-defined inclusion/exclusion criteria may apply