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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: BMS-690514; Drug: Letrozole; Drug: Lapatinib

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • La Rioja, Argentina, 5300
    • Local Institution
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DSK
      • Local Institution
• Mexico
  • Colima, Mexico, 28030
    • Local Institution
• Peru
  • Lima, Peru, 34
    • Local Institution
• United States
  • Texas
    • Abilene, Texas, United States, 79606
      • Texas Oncology-Abilene
    • Beaumont, Texas, United States, 77702
      • Texas Oncology-Beaumont
    • Fort Worth, Texas, United States, 76177
      • Us Oncology Central Pharmacy
  • Washington
    • Yakima, Washington, United States, 98902
      • Yakima Valley Memorial Hospital/North Star Lodge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BMS-690514 + Letrozole	Drug: BMS-690514; Tablets, Oral, 200 mg, once daily, ~ 12 months depending on response; Drug: Letrozole; Tablets, Oral, 2.5 mg, once daily, ~ 12 months depending on response
Active Comparator: Lapatinib + Letrozole	Drug: Letrozole; Tablets, Oral, 2.5 mg, once daily, ~ 12 months depending on response; Drug: Lapatinib; Tablets, Oral, 1500 mg, once daily, ~ 12 months depending on response

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival: defined as time to disease progression	Every 8 weeks
Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response'	Every 8 weeks
Frequency and severity of adverse events in all subjects	Every 4 weeks

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 12, 2010
• First Submitted That Met QC Criteria: February 12, 2010
• First Posted (Estimate): February 15, 2010

Study Record Updates

• Last Update Posted (Estimate): October 12, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Protein Kinase Inhibitors; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole; Lapatinib
• Other Study ID Numbers: CA187-016; 2009-016622-13 (EudraCT Number)