Clinical trial · Interventional
Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors
A Phase 2 Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Hormone Receptor-Positive Breast Cancer Subjects With Acquired Resistance to Non-Steroidal Aromatase Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-754807 | Drug | Dual IGF-1R/InsR Inhibitor BMS-754807 | ALIAS |
| letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BMS-754807
- interventionNames
- Drug: BMS-754807
- type
- EXPERIMENTAL
- label
- BMS-754807 + letrozole
- interventionNames
- Drug: BMS-754807
- Drug: letrozole
Primary outcomes (1)
- measure
- Progression Free Survival Rate at 24 Weeks
- timeFrame
- 24 weeks after initiation of study treatment
- description
- Progression free survival (PFS) rate at 24 weeks after treatment with BMS 754807/letrozole was to be calculated as the total number of subjects neither progressed nor died after 24 weeks of treatment divided by the total number of subjects (with measurable or non-measurable disease) randomized/assigned to combination treatment arm and treated. In participants with measurable disease Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) criteria was to be used to assess disease progression.This outcome was not measured due to early termination of the study.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Postmenopausal women with hormone receptor-positive and HER-2 negative breast cancer * Disease progression following non-steroidal aromatase inhibitor treatment Exclusion Criteria: * Known symptomatic brain metastasis * Medical condition requiring chronic steroids * History of Type 1 or 2 Diabetes * Uncontrolled or significant cardiovascular (CV) disease * Concomitant second malignancies
References
Publications (0)
Data not yet available