Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FEC Chemotherapy · 1 trial · 1 indication
This tpCR was assessed by the IRC. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer \[AJCC\] staging system). The analysis was based on the ITT population with participants grouped by the treatment assigned at the time of randomization. Participants whose tpCR assessment was missing or invalid were counted as not achieving tpCR. The duration of one treatment cycle was 21 days; the administration of therapy in Cycle 5 did not occur until 2 weeks after surgery. The percentages have been rounded off to first decimal point.
| Arm | Type | Description |
|---|---|---|
| Trastuzumab, Pertuzumab, and Chemotherapy | EXPERIMENTAL | Prior to surgery: trastuzumab, pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC): trastuzumab and pertuzumab up to 1 year total. |
| Trastuzumab, Placebo, and Chemotherapy | EXPERIMENTAL | Prior to surgery: trastuzumab, placebo, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/FEC chemotherapy: trastuzumab and placebo up to 1 year total. |
| Name | Type | Description |
|---|---|---|
| FEC Chemotherapy | DRUG | Fluorouracil 500-600 milligrams per square meter (mg/m2), epirubicin 90-120 mg/m2, and cyclophosphamide 500-600 mg/m2 by intravenous (IV) infusion every 3 weeks for three cycles (Cycles 5-7). FEC chemotherapeutic agents will be administered following surgery on Day 1 of each specified cycle. |
| Surgery | PROCEDURE | All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated. |
| Docetaxel | DRUG | Docetaxel IV infusion in 3-week cycles. Neoadjuvant treatment: 75 mg/m2 for Cycles 1-4. |
| Pertuzumab | DRUG | Pertuzumab IV infusion in 3-week cycles. Prior to surgery (neoadjuvant treatment): 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4. After surgery and 3 cycles of FEC chemotherapy (adjuvant treatment): 840 mg loading dose for Cycle 8, followed by 420 mg for Cycles 9-20) |
| Placebo | DRUG | Placebo by IV infusion in 3-week cycles as neoadjuvant treatment (Cycles 1-4)and as adjuvant treatment (Cycles 8-20) |
| Trastuzumab | DRUG | Trastuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4. Adjuvant treatment: 8 mg/kg loading dose for Cycle 8, followed by 6 mg/kg for Cycles 9-20. |
Inclusion Criteria: * Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (\>) 2 centimeters (cm) by standard local assessment technique * Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0) ...
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FEC chemotherapy is a combination chemotherapy regimen used in the treatment of breast cancer. It is studied in early-stage and locally advanced HER2-positive breast cancer, a biomarker-selected population. FEC combines three small-molecule cytotoxic agents: fluorouracil, epirubicin, and cyclophosphamide, given together to attack dividing cancer cells.
FEC chemotherapy is associated with Roche Holding AG, which trades under the ticker RHHBY. Roche develops and supplies the regimen components used in the breast cancer program. FEC is a well-established combination chemotherapy backbone rather than a single proprietary agent, and Roche's involvement reflects its oncology portfolio in HER2-positive breast cancer research.
FEC chemotherapy has been evaluated in Phase 3 clinical development for breast cancer. The program includes one completed Phase 3 trial with 329 participants. Because the available record shows a completed study rather than a marketed approval, FEC should be understood as a clinical-stage chemotherapy regimen under investigation in this breast cancer setting.
FEC chemotherapy has been studied in the Phase 3 trial NCT02586025, titled a study in participants with early-stage or locally advanced HER2-positive breast cancer. That trial compared trastuzumab plus pertuzumab plus docetaxel against trastuzumab plus placebo plus docetaxel. It enrolled 329 participants across China, South Korea, Taiwan, and Thailand, and it is now completed.
Yes. The Phase 3 trial NCT02586025 was randomized, double-blind, and controlled, enrolling 329 participants with early-stage or locally advanced HER2-positive breast cancer. Participants were at least 18 years old, of any sex, and were not healthy volunteers. The study has been completed, and it took place in China, South Korea, Taiwan, and Thailand.
Yes. FEC chemotherapy in this breast cancer program is biomarker selected, meaning enrollment focused on patients whose tumors test positive for human epidermal growth factor receptor 2, or HER2. The Phase 3 trial NCT02586025 specifically enrolled participants with early-stage or locally advanced HER2-positive breast cancer, so the studied population was defined by that biomarker rather than an unselected group.