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

NCT00337649

CompletedPhase 1, Phase 2

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: Epothilone D, Herceptin

Countries: Spain

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (6)

Barcelona, Spain
Barcelona, Spain
Barcelona, Spain
Madrid, Spain
Valencia, Spain
Valencia, Spain