Trial · NCT04129216
The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
NCT04129216, Phase 2, Completed, Johns Hopkins University; results first posted 2024-05-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer. Trials, record NCT04129216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04129216
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
- NCT number
- NCT04129216
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Breast Cancer
- Interventions
- Tamoxifen Citrate, Letrozole, Exemestane, Blueprint, Mammaprint
- First posted
- 2019-10-16
- Last updated
- 2024-05-07
- Results first posted
- 2024-05-07
- Limitations and caveats
- small number of participants
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC) | Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy | This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery. |
| Secondary | Number of Participants With Low or High Score in MammaPrint | Baseline and at Time of surgery (up to 6 weeks) | Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence). |
| Secondary | Median Percent of Tissue ER Positive | Baseline and at Time of surgery (up to 6 weeks) | Median percent of tissue ER positive in matched tissue measured by Immunohistochemistry (IHC) |
| Secondary | Median Percent of Tissue PR Positive | Baseline and at Time of surgery (up to 6 weeks) | Median percent of tissue PR positive in matched tissue measured by Immunohistochemistry (IHC) |
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 | Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC) | Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy | Change in percentage expression of ki 67 | MEAN | |
| SECONDARY | Number of Participants With Low or High Score in MammaPrint | Baseline and at Time of surgery (up to 6 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Percent of Tissue ER Positive | Baseline and at Time of surgery (up to 6 weeks) | percent of tissue ER positive | MEDIAN | |
| SECONDARY | Median Percent of Tissue PR Positive | Baseline and at Time of surgery (up to 6 weeks) | percent of tissue PR positive | MEDIAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC) | Tamoxifen Arm | -3.6 | Standard Deviation 1.06 | Change in percentage expression of ki 67 | |
| Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC) | Letrozole Arm | -5.1 | Standard Deviation 1.82 | Change in percentage expression of ki 67 | |
| Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC) | Exemestane Arm | -4.2 | Standard Deviation 1.71 | Change in percentage expression of ki 67 | |
| Number of Participants With Low or High Score in MammaPrint | Tamoxifen Arm | low risk mammaprint score at baseline | 5 | Participants | |
| Number of Participants With Low or High Score in MammaPrint | Letrozole Arm | low risk mammaprint score at baseline | 7 | Participants | |
| Number of Participants With Low or High Score in MammaPrint | Exemestane Arm | low risk mammaprint score at baseline | 5 | Participants | |
| Number of Participants With Low or High Score in MammaPrint | Tamoxifen Arm | high risk mammaprint score at baseline | 5 | Participants | |
| Number of Participants With Low or High Score in MammaPrint | Letrozole Arm | high risk mammaprint score at baseline | 3 | Participants | |
| Number of Participants With Low or High Score in MammaPrint | Exemestane Arm | high risk mammaprint score at baseline | 5 | Participants | |
| Number of Participants With Low or High Score in MammaPrint | Tamoxifen Arm | low risk mammaprint score at time of surgery (up to 6 weeks) | 7 | Participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tamoxifen Arm | 10 | |
| Overall Study | STARTED | Letrozole Arm | 10 | |
| Overall Study | STARTED | Exemestane Arm | 10 | |
| Overall Study | COMPLETED | Tamoxifen Arm | 10 | |
| Overall Study | COMPLETED | Letrozole Arm | 10 | |
| Overall Study | COMPLETED | Exemestane Arm | 10 | |
| Overall Study | NOT COMPLETED | Tamoxifen Arm | 0 | |
| Overall Study | NOT COMPLETED | Letrozole Arm | 0 | |
| Overall Study | NOT COMPLETED | Exemestane Arm | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tamoxifen Arm | 0 | 10 |
| Total, all-cause mortality | Letrozole Arm | 0 | 10 |
| Total, all-cause mortality | Exemestane Arm | 0 | 10 |
| Total, other adverse events | Tamoxifen Arm | 0 | 10 |
| Total, other adverse events | Letrozole Arm | 0 | 10 |
| Total, other adverse events | Exemestane Arm | 0 | 10 |
| Total, serious adverse events | Tamoxifen Arm | 0 | 10 |
| Total, serious adverse events | Letrozole Arm | 0 | 10 |
| Total, serious adverse events | Exemestane Arm | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26408301 | BACKGROUND |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04129216
GET https://conductscience.org/api/trials/v1/NCT04129216/results?page=2