Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer
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| ClinicalTrials.gov Identifier: NCT01068704 |
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Recruitment Status :
Completed
First Posted : February 15, 2010
Last Update Posted : October 12, 2015
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief 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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: BMS-690514 Drug: Lapatinib Drug: Letrozole | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | June 2010 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| 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: 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 |
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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01068704 |
| Other Study ID Numbers: |
CA187-016 2009-016622-13 ( EudraCT Number ) |
| First Posted: | February 15, 2010 Key Record Dates |
| Last Update Posted: | October 12, 2015 |
| Last Verified: | September 2015 |
Additional relevant MeSH terms:
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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 |