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

Hoffmann-La Roche27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Epothilone D

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Unnamed facility

Barcelona, Spain

Unnamed facility

Barcelona, Spain

Unnamed facility

Barcelona, Spain

Unnamed facility

Madrid, Spain

Unnamed facility

Valencia, Spain

Unnamed facility

Valencia, Spain

Outcomes

Primary Outcomes

Phase I: Number of Participants with a Dose-Limiting Toxicity

Time frame: From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)

Phase II: Objective Response Rate (per RECIST criteria)

Time frame: From first dose of study treatment until documented response (up to 3 years, 2 months)

Secondary Outcomes

Phase II: Duration of Response

Time frame: From date of objective response until progressive disease or death, whichever occurs first (up to 3 years, 2 months)

Phase II: Time to Tumor Progression

Time frame: From first dose of study treatment until progressive disease or death, whichever occurs first (up to 3 years, 2 months)

Phase I: Plasma Concentration of Epothilone D at Specified Timepoints

Time frame: Cycle 1 Days -2, -1, and 1; Cycle 2 Days 1 15-17 (1 cycle is 28 days)

Number of Participants with at Least One Adverse Event

Time frame: From first dose of study treatment until 28 days after last dose (up to 3 years, 2 months)