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Label indication ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ). FDA label
Epirubicin · 2 trials · 2 indications
Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 6 variables are included in a calculation formula.
| Arm | Type | Description |
|---|---|---|
| B | EXPERIMENTAL | ET (8 cycles) T = docetaxel or paclitaxel |
| A | EXPERIMENTAL | EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles T = docetaxel or paclitaxel |
| Chemotherapy | ACTIVE_COMPARATOR | 3 cycles of FEC 100 followed by 3 cycles of Docetaxel Drugs: Fluorouracile, Epirubicine, Cyclophosphamide, Docetaxel |
| Letrozole Palbociclib | EXPERIMENTAL | Drugs: letrozole + palbociclib combination |
| Name | Type | Description |
|---|---|---|
| Epirubicin with Cyclophosphamide, followed by a Taxane | DRUG | Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2 Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2 |
| Epirubicin with a Taxane | DRUG | Epirubicin = 75 mg/m2 per cycle Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2 |
| Fluorouracile | DRUG | - |
| Epirubicin | DRUG | - |
| Cyclophosphamide | DRUG | - |
| Letrozole | DRUG | - |
| Palbociclib | DRUG | - |
Inclusion Criteria: * Breast Cancer Stage T1-3, N1, M0 * Suitable candidate for anthracycline-containing adjuvant chemotherapy Exclusion Criteria: * Evidence of residual tumor following surgery, or metastatic disease * Received prior therapy for breast cancer
Epirubicin is used in the treatment of breast cancer, including neoadjuvant operable breast cancer and adenocarcinoma. It is studied in regimens such as Epirubicin with Cyclophosphamide followed by a Taxane. The drug is being developed by Pfizer, Inc. and is in Phase 3 clinical development.
Epirubicin is developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is responsible for the clinical development of Epirubicin in the studied breast cancer indications.
Epirubicin is in Phase 3 clinical development. It has been evaluated in a completed Phase 3 trial with 606 participants. The drug is investigational and has not been approved by the FDA for the studied indications.
Epirubicin has been studied in clinical trial NCT00140075, a completed Phase 3 trial titled "Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer." This trial enrolled 606 participants with adenocarcinoma in the United States.