Trial · NCT01293032
Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer
NCT01293032, Not applicable, Completed, Virginia Commonwealth University; results first posted 2016-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer. Trials, record NCT01293032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01293032
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer
- NCT number
- NCT01293032
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 59 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- Interventions
- Neoadjuvant Therapy, Therapeutic Conventional Surgery, Laboratory Biomarker Analysis, Gene Expression Analysis, Systemic Chemotherapy, Tamoxifen Citrate, Aromatase Inhibition Therapy
- First posted
- 2011-02-10
- Last updated
- 2016-07-12
- Results first posted
- 2016-07-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment | Up to 2 years | The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment | Up to 2 years | Patients with an intermediate RS(11-25) assigned to Group 2, Arm 1, and Arm 2 were combined in the analysis. | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment | Group 2 (RS 11-25) | 0.15 | 95% Confidence Interval 0.051 to 0.319 | proportion of participants |
Source ClinicalTrials.gov
Participant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Recurrence Score(RS)Assigned/Randomized | STARTED | Group 1 (RS < 11) | 12 | |
| Recurrence Score(RS)Assigned/Randomized | STARTED | Group 2 Arm 1 (RS 11-25) | 17 | |
| Recurrence Score(RS)Assigned/Randomized | STARTED | Group 2 Arm 2 (RS 11-25) | 16 | |
| Recurrence Score(RS)Assigned/Randomized | STARTED | Group 3 (RS > 25) | 14 | |
| Recurrence Score(RS)Assigned/Randomized | Assigned/Randomized to Arm | Group 1 (RS < 11) | 12 | |
| Recurrence Score(RS)Assigned/Randomized | Assigned/Randomized to Arm | Group 2 Arm 1 (RS 11-25) | 17 | |
| Recurrence Score(RS)Assigned/Randomized | Assigned/Randomized to Arm | Group 2 Arm 2 (RS 11-25) | 16 | |
| Recurrence Score(RS)Assigned/Randomized | Assigned/Randomized to Arm | Group 3 (RS > 25) | 14 | |
| Recurrence Score(RS)Assigned/Randomized | COMPLETED | Group 1 (RS < 11) | 12 | |
| Recurrence Score(RS)Assigned/Randomized | COMPLETED | Group 2 Arm 1 (RS 11-25) | 17 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 (RS < 11) | ||
| Total, all-cause mortality | Group 2 Arm 1 (RS 11-25) | ||
| Total, all-cause mortality | Group 2 Arm 2 (RS 11-25) | ||
| Total, all-cause mortality | Group 3 (RS > 25) | ||
| Total, other adverse events | Group 1 (RS < 11) | 0 | 0 |
| Total, other adverse events | Group 2 Arm 1 (RS 11-25) | 0 | 0 |
| Total, other adverse events | Group 2 Arm 2 (RS 11-25) | 0 | 0 |
| Total, other adverse events | Group 3 (RS > 25) | 0 | 0 |
| Total, serious adverse events | Group 1 (RS < 11) | 0 | 0 |
| Total, serious adverse events | Group 2 Arm 1 (RS 11-25) | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016059 | Massey Cancer Center - Cancer Center Support Grant | WINN, ROBERT A. | VIRGINIA COMMONWEALTH UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT01293032
GET https://conductscience.org/api/trials/v1/NCT01293032/flow?page=2