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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00433589 | Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes | PHASE3 | COMPLETED | 6,600 | — | — | Feb 1, 2007 | Mar 1, 2020 | Nov 17, 2022 | 1 | Netherlands |
o The primary endpoint for chemotherapy versus no chemotherapy (R-T) is that the 5-year distant metastasis free survival (DMFS) of 92% will be tested (a one-sided test).
o The primary endpoint for the chemotherapy randomization (R-C) is disease free survival (DFS).
The primary test for the endocrine randomization (R-E) is DFS.
| Arm | Type | Description |
|---|---|---|
| Chemotherapy randomization: Arm I (anthracycline-based) | ACTIVE_COMPARATOR | * FEC 100 * Canadian CEF * CAF * FAC * E-CMF |
| Chemotherapy randomization: Arm II (docetaxel and capecitabine) | EXPERIMENTAL | * Docetaxel * Capecitabine |
| Endocrine therapy randomization: Arm I | ACTIVE_COMPARATOR | 2 years of tamoxifen followed by 5 years of letrozole |
| Endocrine therapy randomization: Arm II | EXPERIMENTAL | 7 years of letrozole |
| Treatment decision randomization: Arm I | ACTIVE_COMPARATOR | chemotherapy-decision-making according to clinical criteria (using Adjuvant! Online) |
| Treatment decision randomization: Arm II | EXPERIMENTAL | chemotherapy-decision-making according to genomic prognosis using the 70-gene signature |
| Name | Type | Description |
|---|---|---|
| anthracycline-based | DRUG | - |
| docetaxel and capecitabine | DRUG | - |
| tamoxifen | DRUG | - |
| Letrozole | DRUG | - |
DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer meeting the following criteria: * T1, T2, or operable T3 disease * Zero to three positive lymph nodes and no distant metastases * Unilateral tumor * Multifocal tumors are allowed provided that they have identical...