Trial · NCT00083174
Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer
NCT00083174, Phase 3, Completed, NCIC Clinical Trials Group; results first posted 2013-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer. Trials, record NCT00083174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00083174
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer
- NCT number
- NCT00083174
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,560 participants, actual
- Lead sponsor
- NCIC Clinical Trials Group
- Conditions
- Breast Cancer
- Interventions
- exemestane
- First posted
- 2004-05-17
- Last updated
- 2023-08-25
- Results first posted
- 2013-05-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Women With Serious Adverse Events | 5 years open-label extension period | Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy. |
| Primary | Invasive Breast Cancer Incidence (Breast Cancer-Free Survival) | Over randomization period of study (median follow-up 35 months) | Invasive breast cancer incidence was estimated from the breast cancer-free survival (BCFS) which was calculated for all women from the day of the randomization to the earliest date of diagnosis for invasive breast cancer. Women who died from other causes were censored at the time of death. If a woman did not develop an invasive breast cancer, or died, BCFS was censored on the date of the last day the woman was known alive (LKA), which was the latest of the date of assessment. Women who had breast cancer before study entry were also censored at the time of randomization. |
| Secondary | Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer | Over randomization period of study (median follow-up 35 months) | It was estimated from the Total Breast Cancer-Free Survival (TBCFS), which was calculated for women who developed invasive or non-invasive (DCIS) breast cancer as the time from the date of randomization to the earliest date of diagnosis for invasive or non-invasive (DCIS) breast cancer. Women who died from other causes were censored at the time of death. Women who had breast cancer before entry were censored at the time of randomization. If a woman did not develop an invasive or non-invasive (DCIS) breast cancer, or died, TBCFS will be censored on the date of last known alive. |
| Secondary | Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events | Over randomization period of study (median follow-up 35 months) | |
| Secondary | Number of Clinical Breast Biopsies | Over randomization period of study (median follow-up 35 months) | |
| Secondary | Incidence of All Clinical Fractures | During protocol treatment over randomization period of study (up to 5 years) | |
| Secondary | Incidence of Clinically Relevant Cardiac Events | During protocol treatment in randomization period (up to 5 years) | Events including myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes and all vascular deaths |
| Secondary | Incidences of Other Malignancies | Over randomization period of study (median follow-up 35 months) | Other malignancies includes any other malignancy which is not in breast. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Women With Serious Adverse Events | 5 years open-label extension period | Postmenopausal women who were randomized to exemestane in original MAP.3 study and chose to continue to receive exemestane for up to 5 years and those randomized to placebo and decided to start 5 years of exemestane. | percentage of women | NUMBER |
| PRIMARY | Invasive Breast Cancer Incidence (Breast Cancer-Free Survival) | Over randomization period of study (median follow-up 35 months) | intention to treat (ITT) | percentage of cases/follow-up person-yr | NUMBER |
| SECONDARY | Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer | Over randomization period of study (median follow-up 35 months) | Intent-to-treat (ITT) | percentage of cases/follow-up person-yr | NUMBER |
| SECONDARY | Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events | Over randomization period of study (median follow-up 35 months) | Intent-to-treat (ITT) | percentage of cases/follow-up person-yr | NUMBER |
| SECONDARY | Number of Clinical Breast Biopsies | Over randomization period of study (median follow-up 35 months) | Women who had at least one clinical breast biopsy | number of clinical breast biopsies | MEDIAN |
| SECONDARY | Incidence of All Clinical Fractures | During protocol treatment over randomization period of study (up to 5 years) | Women who have received treatment | participants | NUMBER |
| SECONDARY | Incidence of Clinically Relevant Cardiac Events | During protocol treatment in randomization period (up to 5 years) | Women who received treatment during randomization period | participants | NUMBER |
| SECONDARY | Incidences of Other Malignancies | Over randomization period of study (median follow-up 35 months) | Women who have received treatment | participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Women With Serious Adverse Events | Open-label Extension: Exemestane | 0.0 | 95% Confidence Interval 0.0 to 0.5 | percentage of women | |
| Invasive Breast Cancer Incidence (Breast Cancer-Free Survival) | Randomization Period: Exemestane | 0.19 | 95% Confidence Interval 0.08 to 0.30 | percentage of cases/follow-up person-yr | |
| Invasive Breast Cancer Incidence (Breast Cancer-Free Survival) | Randomization Period: Placebo | 0.55 | 95% Confidence Interval 0.36 to 0.73 | percentage of cases/follow-up person-yr | |
| Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer | Randomization Period: Exemestane | 0.35 | 95% Confidence Interval 0.20 to 0.50 | percentage of cases/follow-up person-yr | |
| Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer | Randomization Period: Placebo | 0.77 | 95% Confidence Interval 0.54 to 0.99 | percentage of cases/follow-up person-yr | |
| Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events | Randomization Period: Exemestane | 0.07 | 95% Confidence Interval 0.00 to 0.15 | percentage of cases/follow-up person-yr | |
| Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events | Randomization Period: Placebo | 0.20 | 95% Confidence Interval 0.08 to 0.32 | percentage of cases/follow-up person-yr | |
| Number of Clinical Breast Biopsies | Randomization Period: Exemestane | 1 | Full Range 1 to 3 | number of clinical breast biopsies | |
| Number of Clinical Breast Biopsies | Randomization Period: Placebo | 1 | Full Range 1 to 3 | number of clinical breast biopsies | |
| Incidence of All Clinical Fractures | Randomization Period: Exemestane | 149 | participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization Period | STARTED | Randomization Period: Exemestane | 2,285 | |
| Randomization Period | STARTED | Randomization Period: Placebo | 2,275 | |
| Randomization Period | STARTED | Open-label Extension: Exemestane | 0 | |
| Randomization Period | COMPLETED | Randomization Period: Exemestane | 2,285 | |
| Randomization Period | COMPLETED | Randomization Period: Placebo | 2,275 | |
| Randomization Period | COMPLETED | Open-label Extension: Exemestane | 0 | |
| Randomization Period | NOT COMPLETED | Randomization Period: Exemestane | 0 | |
| Randomization Period | NOT COMPLETED | Randomization Period: Placebo | 0 | |
| Randomization Period | NOT COMPLETED | Open-label Extension: Exemestane | 0 | |
| Open-label Extension | STARTED | Randomization Period: Exemestane | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events186
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 | hypertension | Cardiac disorders | Randomization Period: Exemestane | 341 | 2,240 | |
| other | hypertension | Cardiac disorders | Randomization Period: Placebo | 354 | 2,248 | |
| other | hypertension | Cardiac disorders | Open-label Extension: Exemestane | 0 | 0 | |
| other | hot flashes | Endocrine disorders | Randomization Period: Exemestane | 900 | 2,240 | |
| other | hot flashes | Endocrine disorders | Randomization Period: Placebo | 718 | 2,248 | |
| other | hot flashes | Endocrine disorders | Open-label Extension: Exemestane | 0 | 0 | |
| other | fatigue | Endocrine disorders | Randomization Period: Exemestane | 525 | 2,240 | |
| other | fatigue | Endocrine disorders | Randomization Period: Placebo | 465 | 2,248 | |
| other | fatigue | Endocrine disorders | Open-label Extension: Exemestane | 0 | 0 | |
| other | sweating | Endocrine disorders | Randomization Period: Exemestane | 486 | 2,240 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Randomization Period: Exemestane | ||
| Total, all-cause mortality | Randomization Period: Placebo | ||
| Total, all-cause mortality | Open-label Extension: Exemestane | ||
| Total, other adverse events | Randomization Period: Exemestane | 1,963 | 2,240 |
| Total, other adverse events | Randomization Period: Placebo | 1,901 | 2,248 |
| Total, other adverse events | Open-label Extension: Exemestane | 0 | 0 |
| Total, serious adverse events | Randomization Period: Exemestane | 39 | 2,240 |
| Total, serious adverse events | Randomization Period: Placebo | 26 | 2,248 |
| Total, serious adverse events | Open-label Extension: Exemestane | 0 | 2,831 |
Source ClinicalTrials.gov
Papers4
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Randomization Period: Exemestane vs Randomization Period: Placebo: Incidence of All Clinical Fractures | Trial comparisons |
| Randomization Period: Exemestane vs Randomization Period: Placebo: Incidences of Other Malignancies | Trial comparisons |
| Randomization Period: Exemestane vs Randomization Period: Placebo: Incidence of Clinically Relevant Cardiac Events | 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/NCT00083174
GET https://conductscience.org/api/trials/v1/NCT00083174/events?page=2