Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery (WI223281)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03535506|
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : April 7, 2022
This is a feasibility study which will evaluate the effects of pre-operative treatment of DCIS of the breast with palbociclib. Patients with biopsy-proven DCIS are eligible for the study.
There will be 2 independent and unrelated study groups of 12 patients each, for a total of 24 patients:
- Group A, of male or female patients treated with palbociclib single agent (n=12);
- Group B, untreated, of male or female patients who consented translational studies in blood, as well as diagnostic and definitive surgical specimen, but not the pre-operative treatment with palbociclib (n=12).
|Condition or disease||Intervention/treatment||Phase|
|DCIS||Drug: Palbociclib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery|
|Actual Study Start Date :||October 8, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Group A
Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery. They will receive Palbociclib 100mg PO daily x 12 days.
Palbociclib capsules for oral administration contain 125 mg, 100 mg, or 75 mg of palbociclib, a kinase inhibitor.
Other Name: Ibrance
No Intervention: Group B
These patients will receive no pre-operative treatment. Core biopsies from diagnosis and material from definitive surgery will be collected for translational studies and tissue banking. They will also provide blood samples at screening and prior to definitive surgery.
- Feasibility: recruitment rates [ Time Frame: 14 - 40 Days ]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.
- Pathology: descriptive findings on H&E [ Time Frame: 14 - 40 Days ]Pharmacodynamic effects as measured by changes in tissue morphology (evaluated by H&E) in pre- and post-dose tumor specimens
- Pathology: descriptive findings on IHC [ Time Frame: 14 - 40 Days ]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.
- Toxicity based on CTCAE [ Time Frame: 14 - 40 Days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535506
|Contact: Candace Mainor, MD||202-444-2223||Candace.Mainor@gunet.georgetown.edu|
|Contact: Antonella Novielli, RN, MSNemail@example.com|
|United States, District of Columbia|
|MedStar Georgetown University Hospital||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Nellie Novielli, RN 202-784-3923 firstname.lastname@example.org|
|Principal Investigator: Candace Mainor, MD|