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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00841828 | Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients | PHASE2 | COMPLETED | 102 | — | — | Feb 1, 2009 | Dec 1, 2013 | Mar 31, 2023 | 26 | Spain |
Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller\&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D.
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | Epirubicin + Cyclophosphamide -\> Docetaxel + Lapatinib |
| Control | ACTIVE_COMPARATOR | Epirubicin + Cyclophosphamide -\> Docetaxel + Trastuzumab |
| Name | Type | Description |
|---|---|---|
| Epirubicin | DRUG | - |
| Cyclophosphamide | DRUG | - |
| Docetaxel | DRUG | - |
| Lapatinib | DRUG | - |
| Trastuzumab | DRUG | - |
Inclusion Criteria: 1. Signature of the written informed consent. 2. Histological documentation of breast cancer. 3. Stage I (T1, N0M0), IIA (T2N0M0); IIB (T2N1M0, T3N0M0), IIIA (TXN2M0) and IIIB (T3N1M0, T4NXM0) primary resectable breast cancer or locally advanced breast cancer. 4. HER2-positive b...