Trial · NCT00201851
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
NCT00201851, Phase 3, Completed, International Breast Cancer Research Foundation; results first posted 2015-04-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer. Trials, record NCT00201851. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00201851
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
- NCT number
- NCT00201851
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 740 participants, actual
- Lead sponsor
- International Breast Cancer Research Foundation
- Conditions
- Breast Cancer
- Interventions
- Tamoxifen, Surgery: Oophorectomy
- First posted
- 2005-09-20
- Last updated
- 2015-04-29
- Results first posted
- 2015-04-29
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival | two- to three-year accrual and initial two or more years of follow-up period | 5-year disease-free survival |
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 | Disease-free Survival | two- to three-year accrual and initial two or more years of follow-up period | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival | A - Scheduled Surgery | 64 | percentage of participants | ||
| Disease-free Survival | B - Immediate Surgery | 71 | percentage of participants | ||
| Disease-free Survival | C- Immediate Surgery - Nonrandomized | 70 | percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A - Scheduled Surgery | 252 | |
| Overall Study | STARTED | B - Immediate Surgery | 257 | |
| Overall Study | STARTED | C- Immediate Surgery - Nonrandomized | 231 | |
| Overall Study | COMPLETED | A - Scheduled Surgery | 244 | |
| Overall Study | COMPLETED | B - Immediate Surgery | 255 | |
| Overall Study | COMPLETED | C- Immediate Surgery - Nonrandomized | 230 | |
| Overall Study | NOT COMPLETED | A - Scheduled Surgery | 8 | |
| Overall Study | NOT COMPLETED | B - Immediate Surgery | 2 | |
| Overall Study | NOT COMPLETED | C- Immediate Surgery - Nonrandomized | 1 |
Source ClinicalTrials.gov
Adverse events12
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 |
|---|---|---|---|---|---|---|
| serious | Pregnancy | Reproductive system and breast disorders | A - Scheduled Surgery | 0 | 244 | |
| serious | Pregnancy | Reproductive system and breast disorders | B - Immediate Surgery | 1 | 255 | |
| serious | Pregnancy | Reproductive system and breast disorders | C- Immediate Surgery - Nonrandomized | 0 | 230 | |
| serious | Endocervical cancer | Reproductive system and breast disorders | A - Scheduled Surgery | 0 | 244 | |
| serious | Endocervical cancer | Reproductive system and breast disorders | B - Immediate Surgery | 1 | 255 | |
| serious | Endocervical cancer | Reproductive system and breast disorders | C- Immediate Surgery - Nonrandomized | 0 | 230 | |
| serious | Venous thrombosis | Vascular disorders | A - Scheduled Surgery | 0 | 244 | |
| serious | Venous thrombosis | Vascular disorders | B - Immediate Surgery | 1 | 255 | |
| serious | Venous thrombosis | Vascular disorders | C- Immediate Surgery - Nonrandomized | 1 | 230 | |
| serious | Nosocomial pneumonia | Respiratory, thoracic and mediastinal disorders | A - Scheduled Surgery | 0 | 244 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A - Scheduled Surgery | ||
| Total, all-cause mortality | B - Immediate Surgery | ||
| Total, all-cause mortality | C- Immediate Surgery - Nonrandomized | ||
| Total, other adverse events | A - Scheduled Surgery | 0 | 244 |
| Total, other adverse events | B - Immediate Surgery | 0 | 255 |
| Total, other adverse events | C- Immediate Surgery - Nonrandomized | 0 | 230 |
| Total, serious adverse events | A - Scheduled Surgery | 0 | 244 |
| Total, serious adverse events | B - Immediate Surgery | 5 | 255 |
| Total, serious adverse events | C- Immediate Surgery - Nonrandomized | 1 | 230 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31443726 | 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 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/NCT00201851
GET https://conductscience.org/api/trials/v1/NCT00201851/registered