Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CMF · 1 trial · 1 indication
EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.
The median time, in months, between randomization and date of documented occurrence of an EFS event.
| Arm | Type | Description |
|---|---|---|
| HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF | EXPERIMENTAL | Participants with HER2 proto-oncogene positive breast cancer (HER2+) were treated with trastuzumab 8 milligrams per kilogram (mg/kg), intravenous (IV), on Day 1 of Cycle 1, followed by 6 mg/kg, IV, on Day 1 of Cycle 2 to up a maximum of Cycle 17. Participants also received doxorubicin 60 mg/ square meter (m\^2), IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF: cyclophosphamide 600 mg/m\^2, IV; methotrexate 40 mg/m\^2, IV; and 5-fluorouracil 600 mg/m\^2, IV, on Day 1 of Cycles 8 through 10. |
| HER-2+ Doxorubicin/Paclitaxel/CMF | ACTIVE_COMPARATOR | Participants with HER2 proto-oncogene positive breast cancer were treated with doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10. |
| HER-2- Doxorubicin/Paclitaxel/CMF | ACTIVE_COMPARATOR | Participants with HER2 proto-oncogene negative breast cancer were treated with doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10. |
| Name | Type | Description |
|---|---|---|
| Trastuzumab | DRUG | 8mg/kg IV on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycle 2 up a maximum of Cycle 17 |
| Doxorubicin | DRUG | 60 mg/m2 IV on Day 1 of Cycles 1 through 3 |
| Paclitaxel | DRUG | 150 mg/m2 IV on Day 1 of Cycles 1 through 3, followed by 175 mg/m2 IV on Day 1 of Cycles 4 through 7 |
| CMF | DRUG | CMF: Cyclophosphamide (600 mg/m2 IV bolus), methotrexate (40 mg/m2 IV bolus), 5-fluorouracil (600 mg/m2 IV bolus) on Day 1 of Cycles 8 through 10 |
Inclusion Criteria: * female patients, \>=18 years of age, with locally advanced breast cancer. Exclusion Criteria: * previous therapy for any invasive malignancy.
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CMF is a combination chemotherapy regimen being studied for the treatment of breast cancer. It is being evaluated in a Phase 3 clinical trial in women with locally advanced breast cancer, where it is given in combination with Herceptin (trastuzumab).
CMF is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this combination chemotherapy regimen for breast cancer.
CMF is in Phase 3 clinical development. It is an investigational combination chemotherapy regimen for breast cancer and has completed one Phase 3 trial, with no active trials currently ongoing.
CMF has been studied in one completed Phase 3 clinical trial, NCT01998906, titled 'A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer.' The trial enrolled 330 female participants aged 18 years and older across Austria, Germany, Italy, Portugal, Russia, and Spain.
CMF is an investigational combination chemotherapy regimen and is not FDA approved. It is still in clinical development, with a completed Phase 3 trial in breast cancer. Approval status beyond this has not been established.