Trial information
A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer.
Status: Completed
Protocol number: NO17328
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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.
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. Target sample size is 68.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: Epothilone D
Primary outcome: 1. Response rate (RECIST criteria) Time frame: Event driven
Key secondary outcomes: 1. Duration of response, time to tumor progression. Time frame: Event driven
2. AEs, laboratory tests Time frame: Throughout study
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.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/16/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Spain
