Trial information
A Dose-Finding Study of Tarceva (Erlotinib) Given After Vinorelbine and Xeloda in Patients With Metastatic Breast Cancer.
Status: Completed
Protocol number: MO17156
Sponsor: Roche S.p.A.
Company division: Pharmaceutical
Official Scientific Title: A study to determine the optimal dose of Tarceva, given sequentially to Vinorelbine and Xeloda, as first/second-line chemotherapy in patients with metastatic breast cancer.
Brief summary: This study will evaluate the maximum tolerated dose, dose-limiting toxicity and the recommended dose of Tarceva given sequentially to the administration of fixed doses of Vinorelbine and Xeloda, in first-second line treatment of metastatic breast cancer. Patients will receive Xeloda (2000mg/m²/day po on days 1 - 14) and Vinorelbine (25mg/m² iv on days 1 and 8) for up to 8 cycles of 21 days. Responding patients and those with stable disease, will then receive daily oral Tarceva at ascending doses, starting at 50mg/day, until the maximum tolerated dose is reached. Three patients will receive each dose for 1 month before the dose is escalated. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 20.
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: erlotinib[Tarceva]
Primary outcome: 1. Adverse events; laboratory parameters; dose-limiting toxicity.
Key secondary outcomes: 1. Complete remission; partial remission; stable disease; progressive disease; time to progression; overall survival.
Inclusion criteria:
- women aged 18-70 years of age;
- proven diagnosis of breast cancer, with EGFR overexpression;
- stage IV metastatic breast cancer;
- previous chemotherapy with, or contraindications to, anthracyclines and/or taxanes.
Exclusion criteria:
- HER2/neu positive, and candidate for Herceptin treatment;
- >=2 previous chemotherapy regimens for metastatic disease;
- past or current history of neoplasm other than curatively treated non-melanoma skin cancer or cancer in situ of the uterine cervix;
- clinically significant cardiovascular disease.
Gender: Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Trial registration date: 07/19/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Italy
