Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FEC75 · 1 trial · 1 indication
A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ \[DCIS\] or lobular carcinoma in situ \[LCIS\] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | Trastuzumab alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles and Paclitaxel for 4 (21 day) cycles then continued trastuzumab until time of definitive surgery |
| Arm 2 | EXPERIMENTAL | Lapatinib alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued lapatinib until time of definitive surgery |
| Arm 3 | EXPERIMENTAL | Trastuzumab + Lapatinib for 2 weeks then added FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued trastuzumab + lapatinib until time of definitive surgery |
| Name | Type | Description |
|---|---|---|
| Trastuzumab | DRUG | 4mg/kg IV loading dose followed by 2mg/kg IV weekly |
| Paclitaxel | DRUG | 80mg/m2 IV weekly for 4 (21 day) cycles |
| FEC75 | DRUG | 5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles |
| Lapatinib | DRUG | 1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3 |
Inclusion Criteria: * Have signed an informed consent form (ICF) and a Patient Authorization Form (HIPAA). * Have histologically or cytologically confirmed ErbB2- (HER2/neu-) overexpressing invasive breast cancer (T2-4, N0-2). * ErbB2 overexpressing breast cancer, defined as one of the following de...
FEC75 is an investigational small molecule being developed for the treatment of breast cancer, specifically neoplasms of the breast. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
FEC75 is being developed by GSK plc, a global biopharmaceutical company. GSK is listed on the stock exchange under the ticker symbol GSK.
FEC75 is currently in Phase 2 clinical development. It has completed one Phase 2 trial and is not yet approved by the FDA or other regulatory agencies, meaning it remains an investigational drug.
FEC75 has been studied in one completed Phase 2 clinical trial, identified as NCT00524303. This trial enrolled 100 female participants aged 18 years and older with breast cancer in the United States.
FEC75 is not the same as lapatinib. The completed clinical trial NCT00524303 evaluated lapatinib, with or without trastuzumab, in addition to standard neoadjuvant breast cancer therapy. FEC75 is a distinct investigational drug being developed by GSK.