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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01068704
First received: February 12, 2010
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: BMS-690514
Drug: Lapatinib
Drug: Letrozole
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months [ Time Frame: Every 8 weeks according to CT scan ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival: defined as time to disease progression [ Time Frame: Every 8 weeks ] [ Designated as safety issue: Yes ]
  • Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response' [ Time Frame: Every 8 weeks ] [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse events in all subjects [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Lapatinib
Tablets, Oral, 1500 mg, once daily, ~ 12 months depending on response
Drug: Letrozole
Tablets, Oral, 2.5 mg, once daily, ~ 12 months depending on response

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068704

Locations
United States, Texas
Texas Oncology-Abilene
Abilene, Texas, United States, 79606
Texas Oncology-Beaumont
Beaumont, Texas, United States, 77702
Us Oncology Central Pharmacy
Fort Worth, Texas, United States, 76177
United States, Washington
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
Argentina
Local Institution
Rosario, Santa Fe, Argentina, S2000DSK
Local Institution
La Rioja, Argentina, 5300
Mexico
Local Institution
Colima, Mexico, 28030
Peru
Local Institution
Lima, Peru, 34
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01068704     History of Changes
Other Study ID Numbers: CA187-016, 2009-016622-13
Study First Received: February 12, 2010
Last Updated: February 28, 2012
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Peru: Instituto Nacional de Salud
Mexico: Federal Commission for Sanitary Risks Protection
United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: The Swedish Data Inspection Board
Sweden: Swedish National Council on Medical Ethics

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lapatinib
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Aromatase Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014