Trial · NCT00066703
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
NCT00066703, Phase 3, Completed, ETOP IBCSG Partners Foundation; results first posted 2016-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer. Trials, record NCT00066703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00066703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
- NCT number
- NCT00066703
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,672 participants, actual
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Conditions
- Breast Cancer
- Interventions
- exemestane, tamoxifen, triptorelin
- First posted
- 2003-08-07
- Last updated
- 2026-02-06
- Other registries' IDs
- eudract:2004-000168-28
- Results first posted
- 2016-04-05
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 estimate reported at a median follow-up of 72 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 estimate reported at a median follow-up of 72 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 the 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 72 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 breast cancer recurrence at a distant site; or censored at date of last follow-up |
| Secondary | Overall Survival | 8-year estimates, reported at a median follow-up of 9 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 estimate reported at a median follow-up of 72 months | Intention-to-treat | percentage of participants | NUMBER |
| SECONDARY | Breast Cancer-free Interval | 5-year estimate reported at a median follow-up of 72 months | Intention-to-treat | percentage of participants | NUMBER |
| SECONDARY | Distant Recurrence-free Interval | 5-year estimates reported at a median follow-up of 72 months | Intention-to-treat | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | 8-year estimates, reported at a median follow-up of 9 years | Intention-to-treat | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival | T+OFS | 87.3 | 95% Confidence Interval 85.7 to 88.7 | percentage of participants | |
| Disease-free Survival | E+OFS | 91.1 | 95% Confidence Interval 89.7 to 92.3 | percentage of participants | |
| Breast Cancer-free Interval | T+OFS | 88.8 | 95% Confidence Interval 87.3 to 90.1 | percentage of participants | |
| Breast Cancer-free Interval | E+OFS | 92.8 | 95% Confidence Interval 91.6 to 93.9 | percentage of participants | |
| Distant Recurrence-free Interval | T+OFS | 92.0 | 95% Confidence Interval 90.7 to 93.1 | percentage of participants | |
| Distant Recurrence-free Interval | E+OFS | 93.8 | 95% Confidence Interval 92.7 to 94.8 | percentage of participants | |
| Overall Survival | T+OFS | 93.3 | 95% Confidence Interval 92.1 to 94.3 | percentage of participants | |
| Overall Survival | E+OFS | 93.4 | 95% Confidence Interval 92.2 to 94.4 | percentage of 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 | T+OFS | 1,334 | |
| Overall Study | STARTED | E+OFS | 1,338 | |
| Overall Study | COMPLETED | T+OFS | 1,034 | |
| Overall Study | COMPLETED | E+OFS | 1,026 | |
| Overall Study | NOT COMPLETED | T+OFS | 300 | |
| Overall Study | NOT COMPLETED | E+OFS | 312 |
Source ClinicalTrials.gov
Adverse events370
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 | T+OFS | 2 | 1,321 | |
| other | Cardiac-ischemia/infarction | Cardiac disorders | E+OFS | 4 | 1,317 | |
| other | Nausea | Gastrointestinal disorders | T+OFS | 446 | 1,321 | |
| other | Nausea | Gastrointestinal disorders | E+OFS | 478 | 1,317 | |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | T+OFS | 807 | 1,321 | |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | E+OFS | 760 | 1,317 | |
| other | Injection site reaction/extravasation changes | General disorders | T+OFS | 99 | 1,321 | |
| other | Injection site reaction/extravasation changes | General disorders | E+OFS | 86 | 1,317 | |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | T+OFS | 56 | 1,321 | |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | E+OFS | 60 | 1,317 |
1 to 10 of 370Source ClinicalTrials.gov
See all 370 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T+OFS | ||
| Total, all-cause mortality | E+OFS | ||
| Total, other adverse events | T+OFS | 1,293 | 1,321 |
| Total, other adverse events | E+OFS | 1,298 | 1,317 |
| Total, serious adverse events | T+OFS | 484 | 1,321 |
| Total, serious adverse events | E+OFS | 496 | 1,317 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| T+OFS vs E+OFS: serious adverse events |
Source 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/NCT00066703
GET https://conductscience.org/api/trials/v1/NCT00066703/events?page=2