A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

PFS is defined as the date of randomization to the date of the first radiologically documented disease progression (PD) or death due to any cause per local investigator assessment as per RECIST.

Outcome Time Frame:

Every 8 weeks assessed up to 24 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A2210

NCT ID:

NCT01528345

Start Date:

April 2012

Completion Date:

October 2014

Related Keywords:

• Metastatic Breast Cancer
• Breast Cancer
• HER2-, HR+
• post-menopausal
• Locally advanced or metastatic Breast Cancer (HER2-, HR+)
• Breast Neoplasms