Overview

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