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

NCT01068704 — Phase 2, Completed, 4 participants, Bristol-Myers Squibb

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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

Registry	NCT01068704
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	4 (Actual)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Breast Cancer
Interventions	BMS-690514, Lapatinib, Letrozole (Drug)
Dates	start 2010-06-01, primary completion 2010-12-01, completion 2010-12-01, first posted 2010-02-15, last updated 2015-10-12
Locations	8 sites in United States, Argentina, Mexico, Peru

-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

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+Arms and interventions

Arm	Type	Interventions	Description
BMS-690514 + Letrozole	Active comparator	Drug: BMS-690514; Drug: Letrozole
Lapatinib + Letrozole	Active comparator	Drug: Lapatinib; Drug: Letrozole

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

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (8)

Facility	City	Country
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	United States
Local Institution	La Rioja, La Rioja Province	Argentina
Local Institution	Rosario, Santa Fe Province	Argentina
Local Institution	Colima, Colima	Mexico
Local Institution	Lima, Lima Province	Peru

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb

+Funding

NIH grants: 2009