Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Palbociclib · 1 trial · 2 indications
Determined for each subject as a binary variable indicating whether or not the participant experienced any neutropenic adverse event (according to NCI Common Terminology for Adverse Events version 4.0) that leads to permanent treatment discontinuation
| Arm | Type | Description |
|---|---|---|
| Cohort A: First-line therapy | EXPERIMENTAL | Anastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle |
| Cohort B: Maintenance therapy | EXPERIMENTAL | Anastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle |
| Name | Type | Description |
|---|---|---|
| anastrozole | DRUG | Anastrozole by mouth daily |
| Palbociclib | DRUG | Palbociclib by mouth daily days 1-21 every 28 days |
Inclusion Criteria: * Are 18 years of age or older, who are either: * Postmenopausal, as defined by at least one of the following criteria: * Age greater than or equal to 60 years; * Age less than 60 years and cessation of regular menses for at least 12 consecutive months with no alternative p...
Palbociclib is being studied for the treatment of female breast carcinoma, specifically in metastatic HER2-negative breast cancer. It is an investigational small molecule in Phase 2 clinical development, evaluated in combination with anastrozole in a controlled trial enrolling 40 female patients aged 18 years and older.
Palbociclib targets cyclin-dependent kinases (CDKs), as indicated by its '-ciclib' drug class. It is a small molecule designed to inhibit CDK activity, which plays a role in cell cycle regulation. This mechanism is being explored in the context of metastatic HER2-negative breast cancer.
Palbociclib is being developed by Atrium Therapeutics, Inc., a company traded under the ticker symbol RNA. The drug is currently in Phase 2 clinical development for female breast carcinoma, with an active clinical trial underway in the United States.
Palbociclib is in Phase 2 clinical development. It is an investigational drug, not yet approved, and is being evaluated in an active but not recruiting clinical trial for metastatic HER2-negative breast cancer. The trial is a controlled, non-randomized, open-label study with a planned enrollment of 40 participants.
Palbociclib is being studied in clinical trial NCT02942355, titled 'Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer.' This Phase 2 trial is active but not recruiting, enrolling 40 female patients in the United States with female breast carcinoma or breast cancer. The study is biomarker-selected and controlled.