Trial Outcomes & Findings for Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery (NCT NCT03535506)
NCT ID: NCT03535506
Last Updated: 2025-09-26
Results Overview
The approach will be considered feasible if more than 50% of the enrolled patients are treated andcomplete the study.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
5 years
Results posted on
2025-09-26
Participant Flow
Participant milestones
| Measure |
Group A- Palbociclib Before Surgery
Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery. Patients will receive Palbociclib 100mg PO daily x 12 days.
|
Group B- No Pre-operative Treatment
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
12
|
|
Overall Study
COMPLETED
|
5
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery
Baseline characteristics by cohort
| Measure |
Group A- Palbociclib Before Surgery
n=5 Participants
Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery. Patients will receive Palbociclib 100mg PO daily x 12 days.
|
Group B- No Pre-operative Treatment
n=12 Participants
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.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Study was terminated due to lack of accural
The approach will be considered feasible if more than 50% of the enrolled patients are treated andcomplete the study.
Outcome measures
| Measure |
Group A- Palbociclib Before Surgery
n=5 Participants
Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery. Patients will receive Palbociclib 100mg PO daily x 12 days.
|
Group B- No Pre-operative Treatment
n=12 Participants
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
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Subject in group B did not have specimens collected per protocol so was not included in the analysis. Subject in Group A could not be analyzed due to no evidence of disease at the time of definitive surgery.
Number of patients with pathologic changes in breast tissue before and after definitive surgery.
Outcome measures
| Measure |
Group A- Palbociclib Before Surgery
n=4 Participants
Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery. Patients will receive Palbociclib 100mg PO daily x 12 days.
|
Group B- No Pre-operative Treatment
n=11 Participants
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.
|
|---|---|---|
|
Pathologic Changes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Treatment arm evaluated for Changes and 1 participant had no evidence of disease at surgery so there was no surgical specimen available to evaluate.
Number of treated subjects with pharmacodynamic changes evaluated by IHC from diagnostic biopsy to definitive surgery.
Outcome measures
| Measure |
Group A- Palbociclib Before Surgery
n=4 Participants
Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery. Patients will receive Palbociclib 100mg PO daily x 12 days.
|
Group B- No Pre-operative Treatment
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.
|
|---|---|---|
|
Pathology Changes on Immunohistochemistry (IHC)
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsNumber of subjects with an adverse event reported from time of consent until up to 32 days after surgery.
Outcome measures
| Measure |
Group A- Palbociclib Before Surgery
n=5 Participants
Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery. Patients will receive Palbociclib 100mg PO daily x 12 days.
|
Group B- No Pre-operative Treatment
n=12 Participants
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.
|
|---|---|---|
|
Toxcity Based on CTCAE
|
5 Participants
|
0 Participants
|
Adverse Events
Group A- Palbociclib Before Surgery
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group B- No Pre-operative Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A- Palbociclib Before Surgery
n=5 participants at risk
Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery. Patients will receive Palbociclib 100mg PO daily x 12 days.
|
Group B- No Pre-operative Treatment
n=12 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • Number of events 2 • 3 months
|
0.00%
0/12 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • 3 months
|
0.00%
0/12 • 3 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify:
|
20.0%
1/5 • Number of events 1 • 3 months
|
0.00%
0/12 • 3 months
|
|
Infections and infestations
Infections and infestations - Other, specify:
|
20.0%
1/5 • Number of events 1 • 3 months
|
0.00%
0/12 • 3 months
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 2 • 3 months
|
0.00%
0/12 • 3 months
|
|
Psychiatric disorders
Hallucinations
|
20.0%
1/5 • Number of events 1 • 3 months
|
0.00%
0/12 • 3 months
|
|
Reproductive system and breast disorders
Breast pain
|
20.0%
1/5 • Number of events 1 • 3 months
|
0.00%
0/12 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place