Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
anthracycline-based · 1 trial · 1 indication
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...
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Anthracycline-based is a small molecule chemotherapy regimen being studied for the treatment of breast cancer. It is being evaluated in a Phase 3 clinical trial to determine the need for chemotherapy in women with breast cancer that involves no more than 3 lymph nodes. The drug is developed by Novartis AG.
Anthracycline-based is developed by Novartis AG, a company traded on the stock exchange under the ticker symbol NVS. The drug is being investigated for use in breast cancer and is currently in Phase 3 clinical development.
Anthracycline-based is in Phase 3 clinical development for breast cancer. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, with a total enrollment of 6,600 participants.
Anthracycline-based has one completed Phase 3 clinical trial identified as NCT00433589. This trial, titled 'Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes,' enrolled 6,600 female participants aged 18 years and older in the Netherlands.
Anthracycline-based is being studied in a biomarker-selected patient population, meaning the trial uses genetic testing or clinical assessment to determine which patients may benefit from chemotherapy. The trial is randomized and active-controlled, comparing the chemotherapy regimen against an active control.