Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Myocet · 1 trial · 1 indication
For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.
| Arm | Type | Description |
|---|---|---|
| Trastuzumab, Myocet, Paclitaxel; Phase I | EXPERIMENTAL | Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 40 mg/ square meter (m\^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles. Participants also received paclitaxel 60 mg/ m\^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression. |
| Trastuzumab, Myocet, Paclitaxel; Phase II | EXPERIMENTAL | Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 50 mg/m\^2, IV, every 3 weeks, from Week 1 for 6 cycles. Participants also received paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression. |
| Name | Type | Description |
|---|---|---|
| trastuzumab | DRUG | Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression |
| paclitaxel | DRUG | 60 mg/m\^2 IV weekly; dose increased to 70 mg/m\^2, and subsequently 80 mg/m\^2, after 2 treatment cycles with no evidence of DLT until disease progression |
| Myocet | DRUG | 40 mg/m\^2 IV weekly; dose increased to 50 mg/m\^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles |
Inclusion Criteria: * women 18-70 years of age; * metastatic or locally advanced breast cancer; * HER2 overexpression; * \>= 1 measurable lesion. Exclusion Criteria: * prior treatment for advanced breast cancer; * prior treatment with Herceptin; * bone or central nervous system metastasis as the ...
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Myocet is an investigational small molecule being studied for the treatment of breast cancer. It is being evaluated in combination with trastuzumab and chemotherapy in patients with metastatic or locally advanced breast cancer. The drug is still in clinical development and has not been approved for this use.
Myocet is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on the drug for breast cancer, with a completed Phase 1 trial in Spain.
Myocet is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received FDA approval and is still being studied for safety and efficacy in breast cancer.
Myocet has one completed clinical trial, NCT02015676, titled "A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer." The trial enrolled 69 female patients aged 18 years and older in Spain.
Myocet is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for breast cancer. The completed trial, NCT02015676, was a controlled study, but the drug has not yet received regulatory approval.