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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02400567 | Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women | PHASE2 | COMPLETED | 125 | — | — | Jan 1, 2015 | Sep 1, 2020 | Mar 15, 2022 | 2 | France |
Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 6 variables are included in a calculation formula.
| Arm | Type | Description |
|---|---|---|
| Chemotherapy | ACTIVE_COMPARATOR | 3 cycles of FEC 100 followed by 3 cycles of Docetaxel Drugs: Fluorouracile, Epirubicine, Cyclophosphamide, Docetaxel |
| Letrozole Palbociclib | EXPERIMENTAL | Drugs: letrozole + palbociclib combination |
| Name | Type | Description |
|---|---|---|
| Fluorouracile | DRUG | - |
| Epirubicin | DRUG | - |
| Cyclophosphamide | DRUG | - |
| Letrozole | DRUG | - |
| Palbociclib | DRUG | - |
Inclusion Criteria: 1. Aged ≥ 18 years, Post-menopausal women 2. Newly diagnosed and operable unilateral invasive breast cancer, not candidate or uncertain for breast conservation - Note: Multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all share the same ...