Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy

Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy

Experimental: Treatment

The following drugs will be taken for six cycles:
Palbociclib at a dose of 125 mg should be taken by mouth with food on 21 days and 7 days off schedule (meaning: on Days 1-21 of each 28-day cycle).
Letrozole should be taken daily by mouth, every day of each 28-day cycle, at a dose of 2.5 mg.
Goserelin is given as subcutaneous injection every 28 days at a dose of 3.6 mg. It is to be given on Day 1 of each cycle. Goserelin will only be administered to pre-menopausal subjects.

Drug: Palbociclib 125mg
Palbociclib at a dose of 125 mg should be taken by mouth with food on 21 days on 7 days off schedule (meaning: on Days 1-21of each 28-day cycle). If a subject misses a day’s dose entirely, she must be instructed not to make it up the next day but just take her regular dose at the next assigned time. If a subject vomits any time after taking a dose, she must be instructed not to retake the dose but resume subsequent dosing at the next assigned time. If a subject inadvertently takes an extra dose during a day, she must be instructed to not take the next day’s dose.

Source: View full study details on ClinicalTrials.gov

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March 24, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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