Clinical trial NCT00337649: A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
Official title: An Open-label Study to Evaluate the Effect of Combination Therapy With Epothilone D and Herceptin on Tumor Response in Patients With HER-2 Overexpressing Locally Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-06-16
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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 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.

Primary outcomes:
measure: Phase I: Number of Participants with a Dose-Limiting Toxicity
timeFrame: From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)
measure: Phase II: Objective Response Rate (per RECIST criteria)
timeFrame: From first dose of study treatment until documented response (up to 3 years, 2 months)
Secondary outcomes:
measure: Phase II: Duration of Response
timeFrame: From date of objective response until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
measure: Phase II: Time to Tumor Progression
timeFrame: From first dose of study treatment until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
measure: Phase I: Plasma Concentration of Epothilone D at Specified Timepoints
timeFrame: Cycle 1 Days -2, -1, and 1; Cycle 2 Days 1 15-17 (1 cycle is 28 days)
measure: Number of Participants with at Least One Adverse Event
timeFrame: From first dose of study treatment until 28 days after last dose (up to 3 years, 2 months)
Other outcomes:
Locations:
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: