Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole With Lapatinib + Letrozole in Recurrent and Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068704
• Other study ID #: CA187-016
• Secondary ID: 2009-016622-13
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2010
• Last updated: September 23, 2015
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaPeru: Instituto Nacional de SaludMexico: Federal Commission for Sanitary Risks ProtectionUnited States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesSweden: Medical Products AgencySweden: The National Board of Health and WelfareSweden: The Swedish Data Inspection BoardSweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented invasive breast cancer

• Greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor

• HER2+ and HER2- (Human Epidermal growth factor Receptor) disease

• Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane

• ECOG Performance status = 0 or 1

Exclusion Criteria:

• Prior hormonal therapy for metastatic disease

• Prior hormonal therapy with letrozole for adjuvant disease

• Symptomatic brain metastases

• Prior treatment with any tyrosine kinase inhibitor

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• BMS-690514
Tablets, Oral, 200 mg, once daily, ~ 12 months depending on response
• Lapatinib
Tablets, Oral, 1500 mg, once daily, ~ 12 months depending on response
• Letrozole
Tablets, Oral, 2.5 mg, once daily, ~ 12 months depending on response

Locations

Country	Name	City	State
Argentina	Local Institution	La Rioja
Argentina	Local Institution	Rosario	Santa Fe
Mexico	Local Institution	Colima
Peru	Local Institution	Lima
United States	Texas Oncology-Abilene	Abilene	Texas
United States	Texas Oncology-Beaumont	Beaumont	Texas
United States	Us Oncology Central Pharmacy	Fort Worth	Texas
United States	Yakima Valley Memorial Hospital/North Star Lodge	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Mexico,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months		Every 8 weeks according to CT scan	No
Secondary	Progression Free Survival: defined as time to disease progression		Every 8 weeks	Yes
Secondary	Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response'		Every 8 weeks	Yes
Secondary	Frequency and severity of adverse events in all subjects		Every 4 weeks	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form