Breast Cancer
Conditions
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.
Interventions
DRUGEpothilone D
≤100 mg/m\^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks
DRUGHerceptin
4mg/kg iv loading dose, followed by 2mg/kg iv weekly
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Number of Participants with a Dose-Limiting Toxicity | From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days) |
| Phase II: Objective Response Rate (per RECIST criteria) | From first dose of study treatment until documented response (up to 3 years, 2 months) |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Duration of Response | 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 | 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 | 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 | From first dose of study treatment until 28 days after last dose (up to 3 years, 2 months) |
Countries
Spain
Outcome results
None listed