Trial · NCT00295646
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
NCT00295646, Phase 3, Completed, Austrian Breast & Colorectal Cancer Study Group; results first posted 2024-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid. Trials, record NCT00295646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00295646
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
- NCT number
- NCT00295646
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,803 participants, actual
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Conditions
- Breast Cancer
- Interventions
- tamoxifen, anastrozole, zoledronic acid, goserelin
- First posted
- 2006-02-24
- Last updated
- 2024-03-15
- Results first posted
- 2024-03-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause |
| Primary | Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause |
| Secondary | Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | RFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from breast cancer |
| Secondary | Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | RFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from breast cancer |
| Secondary | Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | OS is defined as time from randomization to death from any cause |
| Secondary | Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | OS is defined as time from randomization to death from any cause |
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 | Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis | years | MEDIAN |
| PRIMARY | Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis | years | MEDIAN |
| SECONDARY | Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis | years | MEDIAN |
| SECONDARY | Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis | years | MEDIAN |
| SECONDARY | Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis | years | MEDIAN |
| SECONDARY | Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS) | Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months. | Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis. | years | MEDIAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | AZ (Arimidex+Zoledronate) | NA | Inter-Quartile Range NA to NA | years | |
| Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | TZ (Tamoxifen+Zoledronate) | NA | Inter-Quartile Range NA to NA | years | |
| Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | AC (Arimidex Control) | NA | Inter-Quartile Range NA to NA | years | |
| Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | TC (Tamoxifen Control) | NA | Inter-Quartile Range NA to NA | years | |
| Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | AZ (Arimidex+Zoledronate) | NA | Inter-Quartile Range NA to NA | years | |
| Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | TZ (Tamoxifen+Zoledronate) | NA | Inter-Quartile Range NA to NA | years | |
| Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | AC (Arimidex Control) | NA | Inter-Quartile Range NA to NA | years | |
| Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) | TC (Tamoxifen Control) | NA | Inter-Quartile Range NA to NA | years | |
| Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS) | AZ (Arimidex+Zoledronate) | NA | Inter-Quartile Range NA to NA | years | |
| Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS) | TZ (Tamoxifen+Zoledronate) | NA | Inter-Quartile Range NA to NA | years |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZ (Arimidex+Zoledronate) | 450 | |
| Overall Study | STARTED | TZ (Tamoxifen+Zoledronate) | 450 | |
| Overall Study | STARTED | AC (Arimidex Control) | 453 | |
| Overall Study | STARTED | TC (Tamoxifen Control) | 450 | |
| Overall Study | COMPLETED | AZ (Arimidex+Zoledronate) | 415 | |
| Overall Study | COMPLETED | TZ (Tamoxifen+Zoledronate) | 409 | |
| Overall Study | COMPLETED | AC (Arimidex Control) | 403 | |
| Overall Study | COMPLETED | TC (Tamoxifen Control) | 405 | |
| Overall Study | NOT COMPLETED | AZ (Arimidex+Zoledronate) | 35 | |
| Overall Study | NOT COMPLETED | TZ (Tamoxifen+Zoledronate) | 41 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events368
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 | Arthralgia | Musculoskeletal and connective tissue disorders | AZ (Arimidex+Zoledronate) | 150 | 450 | 464 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | TZ (Tamoxifen+Zoledronate) | 65 | 450 | 133 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | AC (Arimidex Control) | 112 | 453 | 315 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | TC (Tamoxifen Control) | 52 | 450 | 124 |
| other | Bone pain | Musculoskeletal and connective tissue disorders | AZ (Arimidex+Zoledronate) | 185 | 450 | 571 |
| other | Bone pain | Musculoskeletal and connective tissue disorders | TZ (Tamoxifen+Zoledronate) | 132 | 450 | 332 |
| other | Bone pain | Musculoskeletal and connective tissue disorders | AC (Arimidex Control) | 128 | 453 | 439 |
| other | Bone pain | Musculoskeletal and connective tissue disorders | TC (Tamoxifen Control) | 94 | 450 | 274 |
| other | Breast inflammation | Reproductive system and breast disorders | AZ (Arimidex+Zoledronate) | 1 | 450 | 1 |
| other | Breast inflammation | Reproductive system and breast disorders | TZ (Tamoxifen+Zoledronate) | 0 | 450 | 0 |
1 to 10 of 368Source ClinicalTrials.gov
See all 368 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZ (Arimidex+Zoledronate) | 9 | 450 |
| Total, all-cause mortality | TZ (Tamoxifen+Zoledronate) | 7 | 450 |
| Total, all-cause mortality | AC (Arimidex Control) | 18 | 453 |
| Total, all-cause mortality | TC (Tamoxifen Control) | 8 | 450 |
| Total, other adverse events | AZ (Arimidex+Zoledronate) | 355 | 450 |
| Total, other adverse events | TZ (Tamoxifen+Zoledronate) | 320 | 450 |
| Total, other adverse events | AC (Arimidex Control) | 340 | 453 |
| Total, other adverse events | TC (Tamoxifen Control) | 290 | 450 |
| Total, serious adverse events | AZ (Arimidex+Zoledronate) | 67 | 450 |
| Total, serious adverse events | TZ (Tamoxifen+Zoledronate) | 103 | 450 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers16
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 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/NCT00295646
GET https://conductscience.org/api/trials/v1/NCT00295646/results?page=2