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) ...
Top 20 of 92 competitors
FEC Chemotherapy is used for the treatment of breast cancer, specifically in patients with early-stage or locally advanced HER2-positive breast cancer. It is part of a combination regimen evaluated in a clinical trial setting for this indication.
FEC Chemotherapy is developed by Roche Holding AG, a company traded under the ticker RHHBY. The drug is being investigated for use in breast cancer treatment.
FEC Chemotherapy is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed.
FEC Chemotherapy was studied in a Phase 3 clinical trial with the identifier NCT02586025. This trial enrolled 329 participants with early-stage or locally advanced HER2-positive breast cancer and was conducted in China, South Korea, Taiwan, and Thailand.
FEC Chemotherapy is not the same as trastuzumab and pertuzumab. In the clinical trial NCT02586025, FEC Chemotherapy was used as a backbone regimen, and the study compared trastuzumab plus pertuzumab plus docetaxel against trastuzumab plus placebo plus docetaxel.