Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer Patients
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
This is an open-label study to assess the efficacy and tolerability of the combination
Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients.
HER2 status will be confirmed centrally by fluorescence in situ hybridization (FISH).
Phase I: Initial doses will be:
Myocet: 50-60 mg/m² day 1 every 3 weeks; Taxotere 60-75 mg/m² day 1 every 3 weeks; and
Herceptin (4) 2 mg/kg weekly.
Sample size will depend on the number of patients recruited during dose escalation. Three
patients must be recruited in each dose level. If one out of three experiences a
dose-limiting toxicity (DLT), 3 more patients must be recruited in the same dose level.
Considering that there are 4 dose levels to be tested, the estimated number of patients is 9
to 24. Patients receiving the recommended dose (RD) will be incorporated into phase II of the
study.