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 a small molecule oncology drug candidate developed by GSK plc for the treatment of breast neoplasms. It has been studied in a Phase 2 clinical trial in breast cancer. FEC75 is investigational and is not approved for commercial use.
FEC75 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 2 clinical trial evaluating FEC75 in breast cancer.
FEC75 is in Phase 2 clinical development. One Phase 2 trial has been completed, and there are currently no active trials. FEC75 remains investigational and has not been approved by the FDA.
FEC75 has been evaluated in one completed Phase 2 clinical trial, NCT00524303, titled "Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy." The trial enrolled 100 female participants aged 18 years and older in the United States.
Yes, FEC75 is a biomarker-selected therapy. The Phase 2 trial NCT00524303 was active-controlled, randomized, and enrolled 100 participants with breast neoplasms, using biomarker selection to guide treatment.