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Palbociclib PD-0332991 · 1 trial · 5 indications
Invasive disease-free survival (iDFS) is defined according to Hudis (J Clin Oncol 2007) as the time period between randomization and first event (ipsi- or contralateral invasive in-breast or loco-regional recurrence, distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause, invasive contralateral breast cancer, second primary invasive cancer (non-breast)) assessed until the end of study.
| Arm | Type | Description |
|---|---|---|
| Palbociclib | EXPERIMENTAL | Palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle for thirteen cycles |
| Placebo | PLACEBO_COMPARATOR | Placebo of palbociclib once daily day 1 to day 21 followed by 7 days off treatment in a28-day cycle for thirteen cycles |
| Name | Type | Description |
|---|---|---|
| Palbociclib PD-0332991 | DRUG | palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle |
| Placebo | DRUG | Arm B: Placebo of palbociclib once daily day 1 to day 21 followed by 7 days off treatment in a 28-day cycle for thirteen cycles |
Based on protocol G version 11 dated 09 April 2019 Inclusion Criteria 1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requi...
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Palbociclib PD-0332991 is an investigational small molecule being studied for the treatment of breast cancer, specifically in hormone receptor positive, HER2 normal patients with residual disease after neoadjuvant chemotherapy and surgery. It is being evaluated in a Phase 3 clinical trial as an addition to standard endocrine treatment.
Palbociclib PD-0332991 is a CDK 4/6 inhibitor, as indicated by its use in the postneoadjuvant treatment setting for hormone receptor positive, HER2 normal breast cancer. It targets cyclin-dependent kinases 4 and 6, which are involved in cell cycle regulation and are commonly dysregulated in cancer.
Palbociclib PD-0332991 is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting the clinical development of this drug for the breast cancer indication.
Palbociclib PD-0332991 is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients with breast cancer.
Palbociclib PD-0332991 is being studied in a Phase 3 clinical trial with the identifier NCT01864746. This completed trial enrolled 1,250 female participants aged 18 years and older with hormone receptor positive, HER2 normal breast cancer and residual disease after neoadjuvant chemotherapy and surgery. The trial was randomized, double-blind, and placebo-controlled.
Yes, Palbociclib PD-0332991 is the same drug as PD-0332991. The name PD-0332991 is an alternative designation for palbociclib, and both names refer to the same investigational CDK 4/6 inhibitor being developed by Pfizer for breast cancer.