Trial · NCT03535506
Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery
NCT03535506, Phase 2, Terminated, Georgetown University; results first posted 2025-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery. Trials, record NCT03535506. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03535506
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery
- NCT number
- NCT03535506
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Georgetown University
- Conditions
- DCIS
- Interventions
- Palbociclib
- First posted
- 2018-05-24
- Last updated
- 2025-09-26
- Results first posted
- 2025-09-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility: Recruitment Rates | 5 years | The approach will be considered feasible if more than 50% of the enrolled patients are treated andcomplete the study. |
| Secondary | Pathologic Changes | 2 months | Number of patients with pathologic changes in breast tissue before and after definitive surgery. |
| Secondary | Pathology Changes on Immunohistochemistry (IHC) | 2 months | Number of treated subjects with pharmacodynamic changes evaluated by IHC from diagnostic biopsy to definitive surgery. |
| Secondary | Toxcity Based on CTCAE | 3 months | Number of subjects with an adverse event reported from time of consent until up to 32 days after surgery. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Feasibility: Recruitment Rates | 5 years | Study was terminated due to lack of accural | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pathologic Changes | 2 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pathology Changes on Immunohistochemistry (IHC) | 2 months | Treatment arm evaluated for Changes and 1 participant had no evidence of disease at surgery so there was no surgical specimen available to evaluate. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Toxcity Based on CTCAE | 3 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Feasibility: Recruitment Rates | Group A- Palbociclib Before Surgery | 5 | Participants | ||
| Feasibility: Recruitment Rates | Group B- No Pre-operative Treatment | 11 | Participants | ||
| Pathologic Changes | Group A- Palbociclib Before Surgery | 0 | Participants | ||
| Pathologic Changes | Group B- No Pre-operative Treatment | 0 | Participants | ||
| Pathology Changes on Immunohistochemistry (IHC) | Group A- Palbociclib Before Surgery | 4 | Participants | ||
| Toxcity Based on CTCAE | Group A- Palbociclib Before Surgery | 5 | Participants | ||
| Toxcity Based on CTCAE | Group B- No Pre-operative Treatment | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A- Palbociclib Before Surgery | 5 | |
| Overall Study | STARTED | Group B- No Pre-operative Treatment | 12 | |
| Overall Study | COMPLETED | Group A- Palbociclib Before Surgery | 5 | |
| Overall Study | COMPLETED | Group B- No Pre-operative Treatment | 12 | |
| Overall Study | NOT COMPLETED | Group A- Palbociclib Before Surgery | 0 | |
| Overall Study | NOT COMPLETED | Group B- No Pre-operative Treatment | 0 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | Group A- Palbociclib Before Surgery | 1 | 5 | 2 |
| other | Dry mouth | Gastrointestinal disorders | Group B- No Pre-operative Treatment | 0 | 12 | 0 |
| other | Nausea | Gastrointestinal disorders | Group A- Palbociclib Before Surgery | 1 | 5 | 1 |
| other | Nausea | Gastrointestinal disorders | Group B- No Pre-operative Treatment | 0 | 12 | 0 |
| other | Gastrointestinal disorders - Other, specify: | Gastrointestinal disorders | Group A- Palbociclib Before Surgery | 1 | 5 | 1 |
| other | Gastrointestinal disorders - Other, specify: | Gastrointestinal disorders | Group B- No Pre-operative Treatment | 0 | 12 | 0 |
| other | Infections and infestations - Other, specify: | Infections and infestations | Group A- Palbociclib Before Surgery | 1 | 5 | 1 |
| other | Infections and infestations - Other, specify: | Infections and infestations | Group B- No Pre-operative Treatment | 0 | 12 | 0 |
| other | Headache | Nervous system disorders | Group A- Palbociclib Before Surgery | 1 | 5 | 2 |
| other | Headache | Nervous system disorders | Group B- No Pre-operative Treatment | 0 | 12 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A- Palbociclib Before Surgery | 0 | 5 |
| Total, all-cause mortality | Group B- No Pre-operative Treatment | 0 | 12 |
| Total, other adverse events | Group A- Palbociclib Before Surgery | 5 | 5 |
| Total, other adverse events | Group B- No Pre-operative Treatment | 0 | 12 |
| Total, serious adverse events | Group A- Palbociclib Before Surgery | 0 | 5 |
| Total, serious adverse events | Group B- No Pre-operative Treatment | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42649946 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A- Palbociclib Before Surgery vs Group B- No Pre-operative Treatment: Pathologic Changes | Trial comparisons |
| Group A- Palbociclib Before Surgery vs Group B- No Pre-operative Treatment: Toxcity Based on CTCAE | Trial comparisons |
| Group A- Palbociclib Before Surgery vs Group B- No Pre-operative Treatment: Feasibility: Recruitment Rates | Trial comparisons |
| Group A- Palbociclib Before Surgery vs Group B- No Pre-operative Treatment: deaths from any cause | Trial comparisons |
| Group A- Palbociclib Before Surgery vs Group B- No Pre-operative Treatment: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03535506
GET https://conductscience.org/api/trials/v1/NCT03535506/registered