Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02125344 | A Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant Treatment of Patients With High-risk Early Breast Cancer (GeparOcto) | PHASE3 | COMPLETED | 961 | — | — | Dec 1, 2014 | Jan 30, 2017 | Jul 13, 2017 | 1 | Germany |
To compare the pathological complete response (pCR= ypT0/is ypN0) rates of neoadjuvant treatment with sequential, dose-dense, dose-intensified ETC(+HP) vs. weekly PM(Cb)(+HP) in patients with high-risk operable or locally advanced breast cancer. Masked role for assessor.
Only for those patients randomized for the supportive anemia treatment: To compare the frequency of patients reaching hemoglobin (Hb) levels ≥ 11g/dl 6 weeks after treatment start of a first episode of anemia grade ≥2 (Hb \< 10g/dl) between patients receiving supportive treatment for iron deficiency with parental ferric carboxymaltose versus physician's choice (no supportive treatment, oral iron substitution, erythropoiesis-stimulating agent (ESA), or both).
| Arm | Type | Description |
|---|---|---|
| PM(Cb) | EXPERIMENTAL | PM(Cb): paclitaxel 80mg/m² 18 times weekly simultaneously with NPLD (Myocet®)20mg/m² 18 times weekly simultaneously with carboplatin AUC 1.5 18 times weekly (only in patients with TNBC) Patients with HER2-positive disease will receive trastuzumab 6 (8) mg/kg every 3 weeks and pertuzumab 420 (840) mg every 3 weeks simultaneously to all cycles. |
| ETC | ACTIVE_COMPARATOR | ETC: epirubicin 150mg/m² every 2 weeks for 3 cycles followed by paclitaxel 225 mg/m² every 2 weeks for 3 cycles followed cyclophosphamide 2000 mg/m² every 2 weeks for 3 cycles. Patients with HER2-positive disease will receive trastuzumab 6 (8) mg/kg every 3 weeks and pertuzumab 420 (840) mg every 3 weeks simultaneously to all T and C cycles. |
| Name | Type | Description |
|---|---|---|
| non-pegylated liposomal doxorubicin | DRUG | 20 mg/m2, i.V. 18 times weekly |
| Carboplatin | DRUG | Carboplatin AUC 1.5 18 times weekly (only in patients with triple-negative breast cancer). |
| Paclitaxel | DRUG | paclitaxel 80mg/m² 18 times weekly |
| Epirubicin | DRUG | 150mg/m² every 2 weeks for 3 cycles. |
| Cyclophosphamide | DRUG | 2000 mg/m² every 2 weeks for 3 cycles. |
| Pertuzumab | DRUG | 420 (840) mg every 3 weeks simultaneously to all T and C cycles in the ETC arm and to all cycles in the PM(Cb) arm. |
| Trastuzumab | DRUG | Trastuzumab 6 (8) mg/kg every 3 weeks simultaneously to all T and C cycles in the ETC arm and to all cycles in the PM(Cb) arm. |
| Ferric carboxymaltose | DRUG | after first anemia grade ≥2 and in case of randomisation: Ferric carboxymaltose i.V. 1000 mg followed 1 week later by an injection of ferric carboxymaltose i.V. 500 mg (if body weight is \<70 kg) or 1000 mg (if body weight is ≥70 kg). In case body weight is \<50 kg, both dosages will be reduced to 500 mg each. |
Inclusion Criteria: Patients will be eligible for study participation only if they comply with the following criteria: * Written informed consent according to local regulatory requirements prior to beginning specific protocol procedures. * Complete baseline documentation must be submitted via MedC...