Clinical trial · Interventional
A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
An Open-label Study to Evaluate the Effect of Combination Therapy With Epothilone D and Herceptin on Tumor Response in Patients With HER-2 Overexpressing Locally Advanced or Metastatic 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 single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanced or metastatic breast cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at a dose not exceeding 100mg/m2. Herceptin will be administered intravenously on a weekly schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
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 |
|---|---|---|---|
| Epothilone D | Drug | — | UNRESOLVED |
| Herceptin | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase I - Epothilone D Dose Escalation
- interventionNames
- Drug: Epothilone D
- Drug: Herceptin
- type
- EXPERIMENTAL
- label
- Phase II - Epothilone D Maximum Tolerated Dose
- interventionNames
- Drug: Epothilone D
- Drug: Herceptin
Primary outcomes (2)
- measure
- Phase I: Number of Participants with a Dose-Limiting Toxicity
- timeFrame
- From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)
- measure
- Phase II: Objective Response Rate (per RECIST criteria)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * women \>=18 years; * locally advanced or metastatic breast cancer; * HER-2 overexpression (FISH + or IHC 3+); * \>=1 measurable lesion; * up to one prior anthracycline-based chemotherapy regimen in a metastatic setting. Exclusion Criteria: * pre-existing neuropathy \>=grade 2; * known CNS metastases; * congestive heart failure, or myocardial infarction within the last 6 months; * previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix.
References
Publications (0)
Data not yet available