NCT03535506
Version 8 to 9 · Georgetown University
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Manual review pending.
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] 9d86a3310d1c15f486fee1c034386f3770615a4c8c1011d7c5bfe8e2ae273dbe/protocolSection/outcomesModule/primaryOutcomes/0/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Feasibility: recruitment rates
Feasibility: Recruitment Rates
/protocolSection/outcomesModule/primaryOutcomes/0/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. The approach will be considered feasible if more than 50% of the enrolled patients are treated and followed within protocol rules, if collected samples are suitable for studies, and if pathologic changes are detectable when comparing diagnostic and surgical specimens, or treated and untreated specimens. In Group A, patients will be treated with palbociclib alone, providing the opportunity to address if proposing this kind of treatment for these patients is feasible. Obtaining human data and feasibility data would be key for designing efficacy/definitive studies of palbociclib in DCIS. This will be measured through data collected on eCRFs regarding timeline from consent to treatment, and treatment to surgery, including treatment delivery (beginning date, end date, number of tablets taken) and date of definitive surgery, as well as number of drop outs.
The approach will be considered feasible if more than 50% of the enrolled patients are treated andcomplete the study.
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. 14 - 40 Days
5 years
/protocolSection/outcomesModule/secondaryOutcomes/0/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Pathology: descriptive findings on H&E
Pathologic Changes
/protocolSection/outcomesModule/secondaryOutcomes/0/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Pharmacodynamic effects as measured by changes in tissue morphology (evaluated by H&E) in pre- and post-dose tumor specimens
Number of patients with pathologic changes in breast tissue before and after definitive surgery.
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 14 - 40 Days
2 months
/protocolSection/outcomesModule/secondaryOutcomes/1/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Pathology: descriptive findings on IHC
Pathology Changes on Immunohistochemistry (IHC)
/protocolSection/outcomesModule/secondaryOutcomes/1/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Pharmacodynamic effects as measured by changes in biomarkers Cdk4, Cdk6, pRb, Cyclin D1, Cyclin E (evaluated by IHC) in pre- and post-dose tumor specimens.
Number of treated subjects with pharmacodynamic changes evaluated by IHC from diagnostic biopsy to definitive surgery.
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 14 - 40 Days
2 months
/protocolSection/outcomesModule/secondaryOutcomes/2/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Toxicity based on CTCAE
Toxcity Based on CTCAE
/protocolSection/outcomesModule/secondaryOutcomes/2/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Will be evaluated by CTCAE. There is no plan to compare Groups A and B regarding efficacy or toxicity. Toxicity will be descriptive for each treatment group, independently.
Number of subjects with an adverse event reported from time of consent until up to 32 days after surgery.
/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 14 - 40 Days
3 months
/protocolSection/statusModule/statusVerifiedDate 2024-01
2025-09
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2025-09-08
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2025-09-26
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"notes": "Covid-19",
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"populationDescription": "Subject in group B did not have specimens collected per protocol so was not included in the analysis.\nSubject in Group A could not be analyzed due to no evidence of disease at the time of definitive surgery."
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"populationDescription": "Treatment arm evaluated for Changes and 1 participant had no evidence of disease at surgery so there was no surgical specimen available to evaluate."
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{
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