NCT03535506: WI223281

Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery

Terminated Phase 2 Results posted Last updated 26 September 2025

What this trial tests

Phase 2 trial testing Palbociclib in DCIS in 17 participants. Terminated before completion.

Timeline

8 October 2018

Primary endpoint
6 December 2023

6 December 2023

Quick facts

Lead sponsor	Georgetown University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	8 October 2018
Primary completion	6 December 2023
Estimated completion	6 December 2023
Sites	2 locations across United States

Drugs / interventions tested

• Palbociclib (Palbociclib) — full drug profile →

Conditions studied

• DCIS — all drugs for DCIS →

Sponsor

Georgetown University

Who can join

18 and older, any sex, with DCIS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility: Recruitment Rates Primary · 5 years

The approach will be considered feasible if more than 50% of the enrolled patients are treated andcomplete the study.

Group	Value	95% CI
Group A- Palbociclib Before Surgery	5
Group B- No Pre-operative Treatment	11

Pathologic Changes Secondary · 2 months

Number of patients with pathologic changes in breast tissue before and after definitive surgery.

Group	Value	95% CI
Group A- Palbociclib Before Surgery	0
Group B- No Pre-operative Treatment	0

Pathology Changes on Immunohistochemistry (IHC) Secondary · 2 months

Number of treated subjects with pharmacodynamic changes evaluated by IHC from diagnostic biopsy to definitive surgery.

Group	Value	95% CI
Group A- Palbociclib Before Surgery	4

Toxcity Based on CTCAE Secondary · 3 months

Number of subjects with an adverse event reported from time of consent until up to 32 days after surgery.

Group	Value	95% CI
Group A- Palbociclib Before Surgery	5
Group B- No Pre-operative Treatment	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group A- Palbociclib Before Surgery

Serious: 0/5 (0%)

Deaths: 0/5

Group B- No Pre-operative Treatment

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (7 terms — click to expand)

Reaction	System	Group A- Palbociclib Befor…	Group B- No Pre-operative …
Dry mouth	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Gastrointestinal disorders - Other, specify:	Gastrointestinal disorders	—	—
Infections and infestations - Other, specify:	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Hallucinations	Psychiatric disorders	—	—
Breast pain	Reproductive system and breast disorders	—	—

Data from ClinicalTrials.gov NCT03535506 adverse events section.

Sponsor's own description

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:

1. Group A, of male or female patients treated with palbociclib single agent (n=12);
2. 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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An evaluation of palbociclib as a breast cancer treatment option: a current update.
   Gallanis GT, Pericas RI, Riegel AT, Pohlmann PR. · · 2021 · cited 6× · PMID 33198527 · DOI 10.1080/14656566.2020.1838485