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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I - Epothilone D Dose Escalation | Experimental |
| |
| Phase II - Epothilone D Maximum Tolerated Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epothilone D | Drug | ≤100 mg/m^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks |
|
| Measure | Description | 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) |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barcelona | 08035 | Spain | ||||
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|
| Herceptin | Drug | 4mg/kg iv loading dose, followed by 2mg/kg iv weekly |
|
|
| 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) |
| Barcelona |
| 08036 |
| Spain |
| Barcelona | 08041 | Spain |
| Madrid | 28041 | Spain |
| Valencia | 46009 | Spain |
| Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C114026 | desoxyepothilone B |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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