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Label indication IBRANCE is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: • an aromatase inhibitor as initial endocrine-based therapy; or • fulvestrant in patients with disease progression following endocrine therapy. FDA label
Also known as Ibrance
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 being studied for breast cancer, specifically in hormone receptor positive, HER2-normal patients who have residual disease after neoadjuvant chemotherapy and surgery. It is added to standard endocrine treatment in this postneoadjuvant setting. The program is in Phase 3 development.
Palbociclib PD-0332991 is a small molecule inhibitor that targets CDK4, CDK6, and CCND1. By inhibiting these cyclin-dependent kinases and the cyclin D1 pathway, it interferes with cell cycle progression in cancer cells. This mechanism underlies its evaluation in hormone receptor positive breast cancer.
Palbociclib PD-0332991 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating the drug in breast cancer.
Palbociclib PD-0332991 is in Phase 3 clinical development. It is an investigational agent and has not been established as approved for the postneoadjuvant breast cancer setting described in its trial. The Phase 3 study has been completed.
Palbociclib PD-0332991 has been studied in the Phase 3 trial NCT01864746, titled a study of palbociclib in addition to standard endocrine treatment in hormone receptor positive HER2-normal patients with residual disease after neoadjuvant chemotherapy and surgery. The trial enrolled 1,250 participants, was randomized, double-blind, and placebo-controlled, and is completed.
Yes, Palbociclib PD-0332991 refers to the same compound as palbociclib, with PD-0332991 being an alternate research code for the molecule. Both names identify the CDK4, CDK6, and CCND1 inhibitor developed by Pfizer.