Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: letrozole; Drug: BMS-754807

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01225172

CA191-011

Details and patient eligibility

About

The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.

Enrollment: 77 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Postmenopausal women with hormone receptor-positive and HER-2 negative breast cancer
• Disease progression following non-steroidal aromatase inhibitor treatment

Exclusion Criteria:

• Known symptomatic brain metastasis
• Medical condition requiring chronic steroids
• History of Type 1 or 2 Diabetes
• Uncontrolled or significant cardiovascular (CV) disease
• Concomitant second malignancies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

77 participants in 2 patient groups

BMS-754807

Experimental group

Treatment:

Drug: BMS-754807

BMS-754807 + letrozole

Experimental group

Treatment:

Drug: BMS-754807

Drug: letrozole