Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Herceptin · 1 trial · 1 indication
Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| Doxorubicin+Cyclophosphamide (AC) followed by Docetaxel (AC→T) | EXPERIMENTAL | Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles. |
| AC followed by Docetaxel + Herceptin (AC→TH) | EXPERIMENTAL | Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose. |
| Docetaxel + Carboplatin + Herceptin (TCH) | EXPERIMENTAL | Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose. |
| Name | Type | Description |
|---|---|---|
| Doxorubicin | DRUG | - |
| Cyclophosphamide | DRUG | - |
| Docetaxel | DRUG | - |
| Herceptin | DRUG | - |
| Carboplatin | DRUG | - |
Inclusion criteria: * Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the participants for treatment and follow-up. * Accessible for treatment and follow-up at participating centers. * Histologically proven breast cancer with an interval b...
Herceptin is used for the treatment of breast neoplasms, specifically in women with breast cancer. It is being studied as part of a combination chemotherapy regimen, with or without trastuzumab, in a Phase 3 clinical trial setting. The drug is intended for female patients aged 18 years and older.
Herceptin is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research on this drug for the treatment of breast cancer, with the drug currently in Phase 3 development.
Herceptin is currently in Phase 3 clinical development for the treatment of breast cancer. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is a completed, controlled, randomized study that enrolled 3,222 female participants.
Herceptin is associated with one completed Phase 3 clinical trial, identified as NCT00021255. This trial, titled "Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer," enrolled 3,222 female patients aged 18 years and older across multiple countries, including the United States, Argentina, Australia, and many European nations.
Yes, Herceptin is classified as a small molecule drug. It is being developed for the oncology therapeutic area, specifically for the treatment of breast cancer. The drug is administered in a controlled clinical trial setting, and the completed Phase 3 study did not involve biomarker selection for patient enrollment.