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Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01068704
First received: February 12, 2010
Last updated: September 23, 2015
Last verified: September 2015
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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 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
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 ]
Secondary Outcome Measures:
- Progression Free Survival: defined as time to disease progression [ Time Frame: Every 8 weeks ]
- Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response' [ Time Frame: Every 8 weeks ]
- Frequency and severity of adverse events in all subjects [ Time Frame: Every 4 weeks ]
| 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) |
| Sexes 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
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:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01068704 History of Changes |
| Other Study ID Numbers: |
CA187-016 2009-016622-13 ( EudraCT Number ) |
| Study First Received: | February 12, 2010 |
| Last Updated: | September 23, 2015 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Lapatinib Letrozole Antineoplastic Agents Protein Kinase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Aromatase Inhibitors Steroid Synthesis Inhibitors Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017