Clinical trial · Interventional
Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- BMS-690514 + Letrozole
- interventionNames
- Drug: BMS-690514
- Drug: Letrozole
- type
- ACTIVE_COMPARATOR
- label
- Lapatinib + Letrozole
- interventionNames
- Drug: Lapatinib
- Drug: Letrozole
Primary outcomes (1)
- measure
- Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months
- timeFrame
- Every 8 weeks according to CT scan
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available