Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Taxane · 1 trial · 1 indication
Evaluation of the number of patients with a RCB 0-I index as a measure of efficacy. RCB is a continuous variable derived from the primary tumor dimensions, cellularity of the tumor bed, and axillary nodal burden. It is estimated from routine pathological sections of the primary breast tumor site and the regional lymph nodes after the completion of Neoadjuvant therapy. The pathological variables include bidimensional diameters of the primary tumor bed, the proportion of primary tumor area containing invasive carcinoma, the number of positive lymph nodes, and the diameter of the largest nodal metastasis
| Arm | Type | Description |
|---|---|---|
| Arm A: Doxorubicin plus cyclophosphamide and taxane | ACTIVE_COMPARATOR | Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles. Approximately duration of 24 weeks (6 months). |
| Arm B: Letrozole plus abemaciclib +/- LHRH | EXPERIMENTAL | Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- luteinizing hormone-releasing hormone (LHRH) analogs in premenopausal women, up to 12 months, in 28-day cycles. |
| Name | Type | Description |
|---|---|---|
| Doxorubicin | DRUG | Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles. |
| Cyclophosphamide | DRUG | Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles. |
| Taxane | DRUG | Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles. |
| Letrozole | DRUG | Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles |
| Abemaciclib | DRUG | Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles |
| LHRH Analogue | DRUG | Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles |
Inclusion Criteria: Patients are eligible to be enrolled in the study only if they meet all of the following criteria: 1. Written informed consent prior to any specific study procedures. 2. Women ≥ 18 years of age. 3. Documentation of histologically confirmed primary invasive adenocarcinoma of the...
Taxane is a small molecule being studied for the treatment of Early Breast Cancer. It is currently in Phase 2 clinical development as part of a neoadjuvant treatment approach. The drug is being evaluated in a clinical trial for patients with HR+/HER2- high or intermediate risk breast cancer.
Taxane is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Early Breast Cancer.
Taxane is currently in Phase 2 clinical development. It is an investigational drug being studied for the treatment of Early Breast Cancer. The drug has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its effectiveness and safety.
Taxane is being evaluated in a Phase 2 clinical trial with the identifier NCT04293393. This trial is a neoadjuvant study comparing chemotherapy versus letrozole plus abemaciclib in HR+/HER2- high or intermediate risk breast cancer patients. The trial is active but not recruiting, with an enrollment of 200 female participants aged 18 years and older in Spain.
No, Taxane is not the same as abemaciclib. Taxane is a small molecule being studied for Early Breast Cancer, while abemaciclib is a CDK4/6 inhibitor. In the clinical trial NCT04293393, Taxane is being compared against a regimen that includes letrozole plus abemaciclib, indicating they are distinct treatments.