Trial · NCT00038467
Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
NCT00038467, Phase 3, Completed, Pfizer; results first posted 2014-04-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer. Trials, record NCT00038467. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00038467
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
- NCT number
- NCT00038467
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,740 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Breast Neoplasms
- Interventions
- Tamoxifen, Exemestane
- First posted
- 2002-06-03
- Last updated
- 2014-05-07
- Results first posted
- 2014-04-10
- Limitations and caveats
- Other AEs included both SAEs and AEs. Non-SAE could not be presented separately for this study as AEs were collected in clinical database where SAE flags were not collected.
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study | Baseline up to Month 36 | DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ. |
| Secondary | Overall Survival (OS) at Month 36 Post-Randomization: Main Study | Baseline up to Month 120 | OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants' survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data. |
| Secondary | Number of Events of Second Breast Cancer in Contralateral Breast: Main Study | Baseline up to Month 120 | Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported. |
| Secondary | Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment | BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip \[TH\]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Secondary | Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment | BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Secondary | Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment | BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip \[TH\]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant's value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (\>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (\<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Secondary | Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Secondary | Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Secondary | Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively. |
| Secondary | Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
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) at Month 36 Post-Randomization: Main Study | Baseline up to Month 36 | Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received. | probability of DFS | NUMBER |
| SECONDARY | Overall Survival (OS) at Month 36 Post-Randomization: Main Study | Baseline up to Month 120 | ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received. | probability of OS | NUMBER |
| SECONDARY | Number of Events of Second Breast Cancer in Contralateral Breast: Main Study | Baseline up to Month 120 | ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received. | events | NUMBER |
| SECONDARY | Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment | Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment | Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received. | percent change | MEAN |
| SECONDARY | Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment | Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received. | T-score | MEAN |
| SECONDARY | Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. | percentage of baseline concentration | GEOMETRIC_MEAN |
| SECONDARY | Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. | percentage of baseline concentration | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. | percentage of baseline concentration | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. | percentage of baseline concentration | GEOMETRIC_MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group482
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) at Month 36 Post-Randomization: Main Study | Exemestane | 0.90 | 95% Confidence Interval 0.89 to 0.92 | probability of DFS | |
| Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study | Tamoxifen | 0.86 | 95% Confidence Interval 0.85 to 0.88 | probability of DFS | |
| Overall Survival (OS) at Month 36 Post-Randomization: Main Study | Exemestane | 0.953 | 95% Confidence Interval 0.945 to 0.962 | probability of OS | |
| Overall Survival (OS) at Month 36 Post-Randomization: Main Study | Tamoxifen | 0.941 | 95% Confidence Interval 0.932 to 0.951 | probability of OS | |
| Number of Events of Second Breast Cancer in Contralateral Breast: Main Study | Exemestane | 57 | events | ||
| Number of Events of Second Breast Cancer in Contralateral Breast: Main Study | Tamoxifen | 75 | events | ||
| Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Exemestane | Change at 6 months on-treatment: LS (n=84,96) | -2.64 | Standard Deviation 2.89 | percent change |
| Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Tamoxifen | Change at 6 months on-treatment: LS (n=84,96) | -0.22 | Standard Deviation 2.55 | percent change |
| Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Exemestane | Change at 6 months on-treatment: TH (n=82,96) | -1.31 | Standard Deviation 2.20 | percent change |
| Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Tamoxifen | Change at 6 months on-treatment: TH (n=82,96) | -0.13 | Standard Deviation 1.90 | percent change |
1 to 10 of 482Source ClinicalTrials.gov
See all 482 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Exemestane | 2,352 | |
| Overall Study | STARTED | Tamoxifen | 2,372 | |
| Overall Study | Treated | Exemestane | 2,321 | |
| Overall Study | Treated | Tamoxifen | 2,337 | |
| Overall Study | COMPLETED | Exemestane | 1,810 | |
| Overall Study | COMPLETED | Tamoxifen | 1,830 | |
| Overall Study | NOT COMPLETED | Exemestane | 542 | |
| Overall Study | NOT COMPLETED | Tamoxifen | 542 |
Source ClinicalTrials.gov
Adverse events976
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 | Nausea | Gastrointestinal disorders | Exemestane | 200 | 2,249 | |
| other | Nausea | Gastrointestinal disorders | Tamoxifen | 208 | 2,279 | |
| other | Fatigue | General disorders | Exemestane | 367 | 2,249 | |
| other | Fatigue | General disorders | Tamoxifen | 344 | 2,279 | |
| other | Weight increased | Investigations | Exemestane | 128 | 2,249 | |
| other | Weight increased | Investigations | Tamoxifen | 138 | 2,279 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Exemestane | 396 | 2,249 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Tamoxifen | 246 | 2,279 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Exemestane | 208 | 2,249 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Tamoxifen | 176 | 2,279 |
1 to 10 of 976Source ClinicalTrials.gov
See all 976 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exemestane | ||
| Total, all-cause mortality | Tamoxifen | ||
| Total, other adverse events | Exemestane | 1,905 | 2,249 |
| Total, other adverse events | Tamoxifen | 1,888 | 2,279 |
| Total, serious adverse events | Exemestane | 383 | 2,320 |
| Total, serious adverse events | Tamoxifen | 439 | 2,338 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Exemestane vs Tamoxifen: Number of Participants With Fracture: Bone Metabolism Sub-study | Trial comparisons |
| Exemestane vs Tamoxifen: serious adverse 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/NCT00038467
GET https://conductscience.org/api/trials/v1/NCT00038467/registered?page=2