A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
- Registration Number
- NCT00337649
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 27
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase I - Epothilone D Dose Escalation Epothilone D - Phase I - Epothilone D Dose Escalation Herceptin - Phase II - Epothilone D Maximum Tolerated Dose Epothilone D - Phase II - Epothilone D Maximum Tolerated Dose Herceptin -
- Primary Outcome Measures
Name Time Method Phase I: Number of Participants with a Dose-Limiting Toxicity From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days) Phase II: Objective Response Rate (per RECIST criteria) From first dose of study treatment until documented response (up to 3 years, 2 months)
- Secondary Outcome Measures
Name Time Method Phase II: Duration of Response From date of objective response until progressive disease or death, whichever occurs first (up to 3 years, 2 months) Phase II: Time to Tumor Progression From first dose of study treatment until progressive disease or death, whichever occurs first (up to 3 years, 2 months) Phase I: Plasma Concentration of Epothilone D at Specified Timepoints Cycle 1 Days -2, -1, and 1; Cycle 2 Days 1 15-17 (1 cycle is 28 days) Number of Participants with at Least One Adverse Event From first dose of study treatment until 28 days after last dose (up to 3 years, 2 months)