Trial · NCT00066690
Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
NCT00066690, Phase 3, Completed, ETOP IBCSG Partners Foundation; results first posted 2016-09-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer. Trials, record NCT00066690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00066690
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
- NCT number
- NCT00066690
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,066 participants, actual
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Conditions
Estrogen Receptor Positive Breast Cancer, Progesterone Receptor Positive Tumor, Recurrent Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
- Interventions
- Exemestane, Laboratory Biomarker Analysis, Oophorectomy, Quality-of-Life Assessment, Radiation Therapy, Tamoxifen, Triptorelin
- First posted
- 2003-08-07
- Last updated
- 2026-08-26
- Results first posted
- 2016-09-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival | 5-year estimates, reported at a median follow-up of 67 months. | Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up. |
| Secondary | Breast Cancer-free Interval | 5-year estimates, reported at a median follow-up of 67 months. | Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up. |
| Secondary | Distant Recurrence-free Interval | 5-year estimates, reported at a median follow-up of 67 months. | Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up. |
| Secondary | Overall Survival | 8-year estimates, reported at a median follow-up of 8 years | Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive. |
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 | Disease-free Survival | 5-year estimates, reported at a median follow-up of 67 months. | Intention-to-treat | percentage of participants | NUMBER |
| SECONDARY | Breast Cancer-free Interval | 5-year estimates, reported at a median follow-up of 67 months. | Intention-to-treat | percentage of participants | NUMBER |
| SECONDARY | Distant Recurrence-free Interval | 5-year estimates, reported at a median follow-up of 67 months. | Intention-to-treat | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | 8-year estimates, reported at a median follow-up of 8 years | Intention-to-treat | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival | Tamoxifen | 84.7 | 95% Confidence Interval 82.2 to 86.9 | percentage of participants | |
| Disease-free Survival | T+OFS | 86.6 | 95% Confidence Interval 84.2 to 88.7 | percentage of participants | |
| Disease-free Survival | E+OFS | 89 | 95% Confidence Interval 86.8 to 90.9 | percentage of participants | |
| Breast Cancer-free Interval | Tamoxifen | 86.4 | 95% Confidence Interval 84.0 to 88.5 | percentage of participants | |
| Breast Cancer-free Interval | T+OFS | 88.4 | 95% Confidence Interval 86.1 to 90.3 | percentage of participants | |
| Breast Cancer-free Interval | E+OFS | 90.9 | 95% Confidence Interval 88.9 to 92.6 | percentage of participants | |
| Distant Recurrence-free Interval | Tamoxifen | 90.7 | 95% Confidence Interval 88.6 to 92.4 | percentage of participants | |
| Distant Recurrence-free Interval | T+OFS | 91.3 | 95% Confidence Interval 89.2 to 92.9 | percentage of participants | |
| Distant Recurrence-free Interval | E+OFS | 93.0 | 95% Confidence Interval 91.2 to 94.5 | percentage of participants | |
| Overall Survival | Tamoxifen | 91.5 | 95% Confidence Interval 89.4 to 93.2 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 | 1,021 | |
| Overall Study | STARTED | T+OFS | 1,024 | |
| Overall Study | STARTED | E+OFS | 1,021 | |
| Overall Study | COMPLETED | Tamoxifen | 654 | |
| Overall Study | COMPLETED | T+OFS | 751 | |
| Overall Study | COMPLETED | E+OFS | 719 | |
| Overall Study | NOT COMPLETED | Tamoxifen | 367 | |
| Overall Study | NOT COMPLETED | T+OFS | 273 | |
| Overall Study | NOT COMPLETED | E+OFS | 302 |
Source ClinicalTrials.gov
Adverse events528
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 | Cardiac-ischemia/infarction | Cardiac disorders | Tamoxifen | 1 | 1,007 | |
| other | Cardiac-ischemia/infarction | Cardiac disorders | T+OFS | 2 | 1,007 | |
| other | Cardiac-ischemia/infarction | Cardiac disorders | E+OFS | 5 | 1,001 | |
| other | Nausea | Gastrointestinal disorders | Tamoxifen | 239 | 1,007 | |
| other | Nausea | Gastrointestinal disorders | T+OFS | 215 | 1,007 | |
| other | Nausea | Gastrointestinal disorders | E+OFS | 228 | 1,001 | |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | Tamoxifen | 571 | 1,007 | |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | T+OFS | 595 | 1,007 | |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | E+OFS | 591 | 1,001 | |
| other | Injection site reaction/extravasation changes | General disorders | Tamoxifen | 4 | 1,007 |
1 to 10 of 528Source ClinicalTrials.gov
See all 528 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tamoxifen | 87 | 1,007 |
| Total, all-cause mortality | T+OFS | 68 | 1,007 |
| Total, all-cause mortality | E+OFS | 80 | 1,001 |
| Total, other adverse events | Tamoxifen | 951 | 1,007 |
| Total, other adverse events | T+OFS | 982 | 1,007 |
| Total, other adverse events | E+OFS | 980 | 1,001 |
| Total, serious adverse events | Tamoxifen | 315 | 1,007 |
| Total, serious adverse events | T+OFS | 375 | 1,007 |
| Total, serious adverse events | E+OFS | 375 | 1,001 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| U24CA075362 | IBCSG Statistical Center - A Breast Cancer Study Resource | REGAN, MEREDITH M | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 1997 to 2015 |
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/NCT00066690
GET https://conductscience.org/api/trials/v1/NCT00066690/events?page=2