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Also known as Free doxorubicin hydrochloride, Anthracycline
Free doxorubicin · 1 trial · 1 indication
The pCR of breast was based upon histologic examination, as confirmed by a central panel of experts, of resected tissue .
| Arm | Type | Description |
|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | EXPERIMENTAL | Participants will receive MCH (liposomal doxorubicin hydrochloride \[60 milligrams {mg}/square meter {m\^2}\], cyclophosphamide (600 mg/m\^2), and trastuzumab (8 or 6 mg/kilogram {kg}), administered as intravenous (IV) infusion on Day 1 of each of 4 consecutive 21-day cycles. For the first cycle, the loading dose of trastuzumab will be 8 mg/kg; 6 mg/kg will be used for the remaining cycles. After 4 cycles of MCH, the treatment will be changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzumab \[6 mg/kg\]). |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | ACTIVE_COMPARATOR | Participants will receive AC (free doxorubicin hydrochloride \[60 mg/m\^2\] and cyclophosphamide \[600 mg/m\^2\]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment will be changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzumab \[8 or 6 mg/kg\]). For the first cycle, the loading dose of trastuzumab will be 8 mg/kg; 6 mg/kg will be used for the remaining cycles. |
| Name | Type | Description |
|---|---|---|
| Liposomal doxorubicin hydrochloride | DRUG | Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. |
| Cyclophosphamide | DRUG | Cyclophosphamide will be administered per dose and schedule specified in the arm description. |
| Trastuzumab | DRUG | Trastuzumab will be administered per dose and schedule specified in the arm description. |
| Free doxorubicin hydrochloride | DRUG | Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. |
| Docetaxel | DRUG | Docetaxel will be administered per dose and schedule specified in the arm description. |
Main Inclusion Criteria: * Treatment-naive participants with stage II or III invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of HER2. * Participants have at least 1 bidimensionally measurable lesion according to the World Health Organization (WH...
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Free doxorubicin is an investigational small molecule oncology drug being studied in breast cancer. It is also known as free doxorubicin hydrochloride. It is not the same as liposomal doxorubicin, which is a different formulation. Free doxorubicin is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA.
Free doxorubicin is being studied for use in HER2-positive breast cancer. The clinical program is biomarker-selected, meaning participants are chosen based on a specific biomarker, and it enrolled only female participants aged 18 years and older. The research is in Phase 2 and is not yet approved for commercial use.
Free doxorubicin is being developed by Teva Pharmaceutical Industries Limited, a pharmaceutical company whose shares trade under the ticker TEVA. Teva is the sponsor of the clinical program evaluating the drug in HER2-positive breast cancer.
Free doxorubicin is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed for this asset.
Free doxorubicin has been evaluated in one Phase 2 clinical trial, NCT00712881, titled Combination Therapy With MYOCET (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer. The trial enrolled 126 participants, was randomized and active-controlled, and was conducted in Austria, Belgium, France, Germany, Italy, and Spain. It is now completed.
Yes. Free doxorubicin hydrochloride is an alternative name for free doxorubicin. Both names refer to the same investigational small molecule oncology asset being developed by Teva Pharmaceutical Industries Limited for HER2-positive breast cancer.