Clinical trial · Interventional
Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
A Phase I/II Trial of BMS-754807 in Combination With Trastuzumab (Herceptin®) in Subjects With Advanced or Metastatic Her-2-positive Breast Cancer
- 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)
This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with trastuzumab (Herceptin®) in subjects with advanced or metastatic Her-2-positive breast cancer. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with trastuzumab for Phase II studies and provide preliminary evidence of anti-tumor activity in Her-2-positive breast cancer subjects after trastuzumab failure
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 |
| trastuzumab (Herceptin®) | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- Combination
- interventionNames
- Drug: BMS-754807
- Drug: trastuzumab (Herceptin®)
Primary outcomes (1)
- measure
- The dose escalation portion will determine the MTD and recommended Phase 2 dose or dose range of BMS-754807 when administered orally on a daily schedule in combination with trastuzumab administered at standard doses IV on a weekly basis
- timeFrame
- Every 30 days until MTD is reached
Secondary outcomes (5)
- measure
- Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort)
- timeFrame
- Every 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
For additional information on this trial, please call (910) 558-2913 Inclusion Criteria: * Subjects with locally advanced or metastatic Her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. Prior treatment with other Her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab DM-1 etc.) is allowed * Histologic or cytologic diagnosis of Her-2-positive breast cancer * ECOG status 0 - 1 Exclusion Criteria: * Symptomatic brain metastasis * Any condition requiring chronic use of steroids * Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms * History of glucose intolerance * Women of child-bearing potential unwilling or unable to use acceptable contraception methods
References
Publications (0)
Data not yet available