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

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole Lapatinib Lapatinib Ditosylate

U.S. FDA Resources

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 (Adult, Senior)
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:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site


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:	September 23, 2015
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 Letrozole Lapatinib Antineoplastic Agents Aromatase Inhibitors	Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016