A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

Roche

Status and phase

Completed

Phase 2

Phase 1

Conditions

Breast Cancer

Treatments

Drug: Herceptin

Drug: Epothilone D

Study type

Interventional

Funder types

Industry

Identifiers

NCT00337649

NO17328

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.