Trial · NCT00036270
Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
NCT00036270, Phase 3, Completed, Pfizer; results first posted 2009-12-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane. Trials, record NCT00036270. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00036270
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
- NCT number
- NCT00036270
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 9,779 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Breast Neoplasms
- Interventions
- exemestane (Aromasin), tamoxifen + exemestane
- First posted
- 2002-05-09
- Last updated
- 2015-10-28
- Results first posted
- 2009-12-04
- Limitations and caveats
- Overall Survival was reported as number of events which otherwise reported as time.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years | Baseline (Month 0) up to 2.75 years | Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse. |
| Primary | Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years | Baseline (Month 0) up to 5 years | Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse. |
| Secondary | Number of Events for Overall Survival (OS) | Baseline (Month 0) up to 5 years | Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact. |
| Secondary | Time to New Primary Breast Cancers | Baseline (Month 0) up to 5 years | New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC). |
| Secondary | Number of Events for Time to Relapse | Baseline (Month 0) up to 5 years | Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer. |
| Secondary | Number of Participants With New Primary Non-breast Cancers | Baseline (Month 0) up to 5 years | Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years | Baseline (Month 0) up to 2.75 years | Intent-to-Treat (ITT) population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at 2.75 years. | Events (disease relapse or death) | NUMBER |
| PRIMARY | Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years | Baseline (Month 0) up to 5 years | ITT population included all participants who were randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009. | Events (disease relapse or death) | NUMBER |
| SECONDARY | Number of Events for Overall Survival (OS) | Baseline (Month 0) up to 5 years | ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009. | Events (death) | NUMBER |
| SECONDARY | Time to New Primary Breast Cancers | Baseline (Month 0) up to 5 years | Data was not analyzed due to insufficient number of events reported for the endpoint. | ||
| SECONDARY | Number of Events for Time to Relapse | Baseline (Month 0) up to 5 years | ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009. | Events (disease relapse) | NUMBER |
| SECONDARY | Number of Participants With New Primary Non-breast Cancers | Baseline (Month 0) up to 5 years | ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years | Exemestane | 352 | Events (disease relapse or death) | ||
| Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years | Tamoxifen Followed by Exemestane | 388 | Events (disease relapse or death) | ||
| Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years | Exemestane | 712 | Events (disease relapse or death) | ||
| Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years | Tamoxifen Followed by Exemestane | 714 | Events (disease relapse or death) | ||
| Number of Events for Overall Survival (OS) | Exemestane | 485 | Events (death) | ||
| Number of Events for Overall Survival (OS) | Tamoxifen Followed by Exemestane | 476 | Events (death) | ||
| Number of Events for Time to Relapse | Exemestane | 499 | Events (disease relapse) | ||
| Number of Events for Time to Relapse | Tamoxifen Followed by Exemestane | 521 | Events (disease relapse) | ||
| Number of Participants With New Primary Non-breast Cancers | Exemestane | Colorectal cancer | 43 | Participants | |
| Number of Participants With New Primary Non-breast Cancers | Tamoxifen Followed by Exemestane | Colorectal cancer | 32 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized to Study Treatment | STARTED | Exemestane | 4,904 | |
| Randomized to Study Treatment | STARTED | Tamoxifen Followed by Exemestane | 4,875 | |
| Randomized to Study Treatment | COMPLETED | Exemestane | 4,898 | |
| Randomized to Study Treatment | COMPLETED | Tamoxifen Followed by Exemestane | 4,868 | |
| Randomized to Study Treatment | NOT COMPLETED | Exemestane | 6 | |
| Randomized to Study Treatment | NOT COMPLETED | Tamoxifen Followed by Exemestane | 7 | |
| Study Treatment to 5 Year Report | STARTED | Exemestane | 4,898 | |
| Study Treatment to 5 Year Report | STARTED | Tamoxifen Followed by Exemestane | 4,868 | |
| Study Treatment to 5 Year Report | Treated | Exemestane | 4,852 | |
| Study Treatment to 5 Year Report | Treated | Tamoxifen Followed by Exemestane | 4,814 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events1,596
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 | Vertigo | Ear and labyrinth disorders | Tamoxifen Followed by Exemestane | 78 | 4,814 | |
| other | Vertigo | Ear and labyrinth disorders | Exemestane | 96 | 4,852 | |
| other | Abdominal pain | Gastrointestinal disorders | Tamoxifen Followed by Exemestane | 150 | 4,814 | |
| other | Abdominal pain | Gastrointestinal disorders | Exemestane | 141 | 4,852 | |
| other | Constipation | Gastrointestinal disorders | Tamoxifen Followed by Exemestane | 274 | 4,814 | |
| other | Constipation | Gastrointestinal disorders | Exemestane | 236 | 4,852 | |
| other | Diarrhoea | Gastrointestinal disorders | Tamoxifen Followed by Exemestane | 258 | 4,814 | |
| other | Diarrhoea | Gastrointestinal disorders | Exemestane | 302 | 4,852 | |
| other | Dry mouth | Gastrointestinal disorders | Tamoxifen Followed by Exemestane | 98 | 4,814 | |
| other | Dry mouth | Gastrointestinal disorders | Exemestane | 70 | 4,852 |
1 to 10 of 1,596Source ClinicalTrials.gov
See all 1,596 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tamoxifen Followed by Exemestane | ||
| Total, all-cause mortality | Exemestane | ||
| Total, other adverse events | Tamoxifen Followed by Exemestane | 3,551 | 4,814 |
| Total, other adverse events | Exemestane | 3,567 | 4,852 |
| Total, serious adverse events | Tamoxifen Followed by Exemestane | 784 | 4,814 |
| Total, serious adverse events | Exemestane | 831 | 4,852 |
Source ClinicalTrials.gov
Papers6
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 |
|---|
| Tamoxifen Followed by Exemestane vs Exemestane: 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/NCT00036270
GET https://conductscience.org/api/trials/v1/NCT00036270/events?page=2