Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PTC-Pz · 1 trial · 1 indication
Number of patients without progression of disease recurrence, second primary or death
| Arm | Type | Description |
|---|---|---|
| PTC-Pz | EXPERIMENTAL | * Paclitaxel 80mg/m2 administered intravenously on day 1 and day 8 * Herceptin® 6mg/kg administered intravenously on day 1 (loading dose 8mg/kg) or Herceptin® administered subcutaneously 600mg on day 1 * Carboplatin AUC 6mg•ml/min administered intravenously on day 1 * Pertuzumab 420mg administered intravenously on day 1 (loading dose 840mg) * Treatment cycles are repeated on day 22 Patients who do not achieve pCR will complete a total of nine cycles taxane-containing chemotherapy followed by 14 cycles of treatment with adjuvant T-DM1. |
| Name | Type | Description |
|---|---|---|
| PTC-Pz | DRUG | * Paclitaxel 80mg/m2 administered intravenously on day 1 and day 8 * Herceptin® 6mg/kg administered intravenously on day 1 (loading dose 8mg/kg) or Herceptin® administered subcutaneously 600mg on day 1 * Carboplatin AUC 6mg•ml/min administered intravenously on day 1 * Pertuzumab 420mg administered intravenously on day 1 (loading dose 840mg) * Treatment cycles are repeated on day 22 In case of non pCR; Adjuvant T-DM1, 3.6mg/kg Q 22 days, for 14 cycles. |
Inclusion Criteria: 1. Histologically confirmed primairy infiltrating breast cancer. 2. Stage II or Ill disease. 3. Overexpression and/or amplification of HER2 in an invasive component of the core biopsy. 4. Age \<:18 5. ECOG Group performance status 6. LVEF \>50% measured by echocardiography, MRI ...
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