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- Check32 days agoChange DetectedThe value 'Show more Show more Show more Revision: v2.9.0' has recently changed to 'Show less Show less MedlinePlus Genetics related topics: Breast cancer MedlinePlus related topics: Breast Cancer Hormones Drug Information available for: Palbociclib FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Quadruple ( Participant Care Provider Investigator Outcomes Assessor ) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Palbociclib 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 Drug : Palbociclib PD-0332991 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 Other Names: Ibrance Placebo Comparator : Placebo Placebo of palbociclib once daily day 1 to day 21 followed by 7 days off treatment in a28-day cycle for thirteen cycles Drug : Placebo 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 Primary Outcome Measures Outcome Measure Measure Description Time Frame Invasive Disease Free Survival (iDFS) for Palbociclib vs. Placebo in Patients With High CPS-EG Score After Neoadjuvant Chemotherapy Receiving Standard Adjuvant Endocrine Therapy for HR-positive/HER2-normal Primary Breast Cancer. 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. From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) Secondary Outcome Measures Outcome Measure Measure Description Time Frame iDFS Excluding Second Non-breast Cancers Invasive disease-free survival (iDFS) is defined according to Hudis (J Clin Oncol 2007) as the time period between randomization and first event assessed until the end of study. From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) Distant Disease Free Survival (DDFS) Distant disease free survival (DDFS) is defined as the time period between randomization and diagnosis of first distant breast cancer recurrences assessed until the end of study. From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) Overall Survival (OS) Overall survival (OS) is defined as the time period between randomization and death of any cause assessed until the end of study. From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) Additional Relevant MeSH Terms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Breast Neoplasms Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Palbociclib Study Documents Provided by German Breast Group Study Protocol [ PDF , 2.76MB, 2019-04-09 ] Statistical Analysis Plan [ PDF , 0.69MB, 2020-09-21 ] Informed Consent Form [ PDF , 0.3MB, 2017-05-04 ] Helpful Links Provided by German Breast Group General trial information Revision: v2.9.1'SummaryDifference13%
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