Trial · NCT00072462
Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
NCT00072462, Phase 3, Completed, Queen Mary University of London; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ. Trials, record NCT00072462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00072462
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
- NCT number
- NCT00072462
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,980 participants, actual
- Lead sponsor
- Queen Mary University of London
- Conditions
- Breast Cancer
- Interventions
- tamoxifen citrate, Anastrozole
- First posted
- 2003-11-06
- Last updated
- 2024-09-19
- Other registries' IDs
- isrctn:ISRCTN31488319
- Results first posted
- 2024-09-19
- Limitations and caveats
- This CTIMP trial, which recruited between 03 Mar 2003 and 08 Feb 2012, formally ended on 31 May 2021.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours | Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). | |
| Secondary | Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours | Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). | |
| Secondary | Number of Participants With ER- Breast Cancer Recurrence | Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). | |
| Secondary | Number of Breast Cancer Deaths | Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). | |
| Secondary | Number of Non-breast Cancer Deaths | Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours | Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours | Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With ER- Breast Cancer Recurrence | Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Breast Cancer Deaths | Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Non-breast Cancer Deaths | Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours | Anastrozole | 103 | Participants | ||
| Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours | Tamoxifen | 120 | Participants | ||
| Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours | Anastrozole | 58 | Participants | ||
| Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours | Tamoxifen | 82 | Participants | ||
| Number of Participants With ER- Breast Cancer Recurrence | Anastrozole | 24 | Participants | ||
| Number of Participants With ER- Breast Cancer Recurrence | Tamoxifen | 15 | Participants | ||
| Number of Breast Cancer Deaths | Anastrozole | 3 | Participants | ||
| Number of Breast Cancer Deaths | Tamoxifen | 3 | Participants | ||
| Number of Non-breast Cancer Deaths | Anastrozole | 59 | Participants | ||
| Number of Non-breast Cancer Deaths | Tamoxifen | 65 | 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 | Anastrozole | 1,471 | |
| Overall Study | STARTED | Tamoxifen | 1,509 | |
| Overall Study | COMPLETED | Anastrozole | 1,449 | |
| Overall Study | COMPLETED | Tamoxifen | 1,489 | |
| Overall Study | NOT COMPLETED | Anastrozole | 22 | |
| Overall Study | NOT COMPLETED | Tamoxifen | 20 |
Source ClinicalTrials.gov
Adverse events3,342
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 | Ankle fracture | Injury, poisoning and procedural complications | Anastrozole | 9 | 1,449 | |
| other | Ankle fracture | Injury, poisoning and procedural complications | Tamoxifen | 10 | 1,489 | |
| other | Bone fragmentation | Injury, poisoning and procedural complications | Anastrozole | 1 | 1,449 | |
| other | Bone fragmentation | Injury, poisoning and procedural complications | Tamoxifen | 0 | 1,489 | |
| other | Bursa injury | Injury, poisoning and procedural complications | Anastrozole | 0 | 1,449 | |
| other | Bursa injury | Injury, poisoning and procedural complications | Tamoxifen | 1 | 1,489 | |
| other | Cartilage injury | Injury, poisoning and procedural complications | Anastrozole | 1 | 1,449 | |
| other | Cartilage injury | Injury, poisoning and procedural complications | Tamoxifen | 1 | 1,489 | |
| other | Cervical vertebral fracture | Injury, poisoning and procedural complications | Anastrozole | 1 | 1,449 | |
| other | Cervical vertebral fracture | Injury, poisoning and procedural complications | Tamoxifen | 0 | 1,489 |
1 to 10 of 3,342Source ClinicalTrials.gov
See all 3,342 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anastrozole | 62 | 1,449 |
| Total, all-cause mortality | Tamoxifen | 69 | 1,489 |
| Total, other adverse events | Anastrozole | 1,323 | 1,449 |
| Total, other adverse events | Tamoxifen | 1,380 | 1,489 |
| Total, serious adverse events | Anastrozole | 333 | 1,449 |
| Total, serious adverse events | Tamoxifen | 371 | 1,489 |
Source ClinicalTrials.gov
Papers3
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anastrozole vs Tamoxifen: Number of Breast Cancer Deaths | Trial comparisons |
| Anastrozole vs Tamoxifen: Number of Participants With ER- Breast Cancer Recurrence | Trial comparisons |
| Anastrozole vs Tamoxifen: Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours | Trial comparisons |
| Anastrozole vs Tamoxifen: Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours | Trial comparisons |
| Anastrozole vs Tamoxifen: Number of Non-breast Cancer Deaths | Trial comparisons |
| Anastrozole vs Tamoxifen: deaths from any cause | Trial comparisons |
| Anastrozole 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/NCT00072462
GET https://conductscience.org/api/trials/v1/NCT00072462/events?page=2