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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02344472 | Detect V / CHEVENDO (Chemo vs. Endo) | PHASE3 | ACTIVE NOT_RECRUITING | 271 | — | — | Sep 1, 2015 | Jan 31, 2025 | Jun 4, 2024 | 1 | Germany |
safety of a dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (riobciclib) plus endocrine therapy as compared to a dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus chemotherapy (followed by endocrine therapy plus ribociclib in combination with trastuzumab and pertuzumab as maintenance therapy) by the proportion of patients experiencing any adverse event (as defined by the modified adverse event score)
| Arm | Type | Description |
|---|---|---|
| Chemotherapy with docetaxel | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus docetaxel. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with paclitaxel | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus paclitaxel.Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with vinorelbine | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus vinorelbine. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with capecitabine | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus capecitabine. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| endocrine therapy with exemestane | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus exemestane. |
| endocrine therapy with fulvestrant | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus fulvestrant. |
| endocrine therapy with anastrozole | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus anastrozole. |
| endocrine therapy with letrozole | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus letrozole. |
| Chemotherapy with nab-Paclitaxel | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus nab-Paclitaxel. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with eribulin | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus eribulin. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| endocrine therapy with leuprorelin | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus leuprorelin. |
| endocrine therapy with goserelin | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus goserelin. |
| Name | Type | Description |
|---|---|---|
| pertuzumab | DRUG | HER2 targeted Therapy |
| Trastuzumab | DRUG | HER2 targeted Therapy |
| Capecitabine | DRUG | Chemotherapy |
| Paclitaxel | DRUG | Chemotherapy |
| Vinorelbine | DRUG | Chemotherapy |
| Docetaxel | DRUG | Chemotherapy |
| Exemestane | DRUG | endocrine therapy |
| Letrozole | DRUG | endocrine therapy |
| Anastrozole | DRUG | endocrine therapy |
| Fulvestrant | DRUG | endocrine therapy |
| Ribociclib | DRUG | CDK 4/6 inhibitor |
| nab-Paclitaxel | DRUG | chemotherapy |
| eribulin | DRUG | chemotherapy |
| leuprorelin | DRUG | endocrine therapy |
| goserelin | DRUG | endocrine therapy |
Inclusion criteria: * Signed, written informed consent in study participation * The primary tumor and/or biopsies from metastatic sites or locoregional recurrences have been confirmed as HER2-positive (FISH-positive or IHC 3+) and hormone receptor positive breast cancer by histopathology according ...