Trial · NCT00053898
Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy
NCT00053898, Phase 3, Completed, NSABP Foundation Inc; results first posted 2018-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy. Trials, record NCT00053898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00053898
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy
- NCT number
- NCT00053898
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,104 participants, actual
- Lead sponsor
- NSABP Foundation Inc
- Conditions
- Breast Cancer
- Interventions
- anastrozole, tamoxifen citrate, Radiation Therapy
- First posted
- 2003-02-06
- Last updated
- 2018-09-20
- Results first posted
- 2018-03-12
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Free From Breast Cancer | 10 years | Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS. |
| Secondary | Percentage of Patients Free From Invasive Breast Cancer | 10 years | Percentage of patients free from an invasive breast cancer event where events include invasive local, regional, or distant recurrence, or contralateral breast cancer, occurring as a first cancer event. Note that this endpoint includes only invasive breast cancers and the primary endpoint includes both invasive and DCIS breast cancers. |
| Secondary | Percentage of Patients Free From Ipsilateral Recurrence | 10 years | Percentage of patients free from a breast cancer recurrence in the ipsilateral breast (invasive and DCIS), occurring as a first cancer event. |
| Secondary | Percentage of Patients Free From Contralateral Breast Cancer | 10 years | Percentage of patients free from a breast cancer recurrence in the contralateral breast (invasive and DCIS), occurring as a first cancer event. |
| Secondary | Percentage of Patients Free From Non-breast Secondary Cancer | 10 years | Percentage of patients free from any non-breast second primary cancer other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, or carcinoma in situ of the cervix, occurring as a first cancer event. |
| Secondary | Percentage of Patients Free From Osteoporotic Fractures | 10 years | Percentage of patients free from fractures of the hip, spine, and wrist. |
| Secondary | Percentage of Patients Alive and Disease-free | 10 years | Percentage of patients free from a disease-free survival event where events include any recurrence, second primary cancer, and death from any cause. Lobular carcinoma in situ (LCIS), basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, and cervical carcinoma in situ will not be included as recurrences or second primary cancer. |
| Secondary | Percentage of Patients Alive (Overall Survival) | 10 years | Percentage of patients alive. |
| Secondary | Quality of Life-Short Form 12 (SF-12) Physical Health Component Score | 5 years | The primary outcome of the QOL substudy was the Medical Outcomes Study-Short Form 12 (SF-12) physical health component scale score. The SF-12 physical score was calculated to have a range of 0-100 and was normalized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health. |
| Secondary | Quality-adjusted Survival Time | 10 years | The mean quality-adjusted survival time (in months) in each treatment group, estimated by the Quality-Adjusted Time without Symptoms and Toxicity (Q-TWIST) method. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Free From Breast Cancer | 10 years | percentage of participants event-free | NUMBER | |
| SECONDARY | Percentage of Patients Free From Invasive Breast Cancer | 10 years | percentage of participants event-free | NUMBER | |
| SECONDARY | Percentage of Patients Free From Ipsilateral Recurrence | 10 years | percentage of participants event-free | NUMBER | |
| SECONDARY | Percentage of Patients Free From Contralateral Breast Cancer | 10 years | percentage of participants event-free | NUMBER | |
| SECONDARY | Percentage of Patients Free From Non-breast Secondary Cancer | 10 years | percentage of participants event-free | NUMBER | |
| SECONDARY | Percentage of Patients Free From Osteoporotic Fractures | 10 years | The analysis for osteoporotic fractures included those whose method of contact for follow-up was by telephone. Two participants were excluded from the analysis because their date of fracture was unknown. | percentage of participants event-free | NUMBER |
| SECONDARY | Percentage of Patients Alive and Disease-free | 10 years | percentage of participants event-free | NUMBER | |
| SECONDARY | Percentage of Patients Alive (Overall Survival) | 10 years | The analysis for overall survival included those whose method of contact for follow-up was by telephone. | percentage of participants event-free | NUMBER |
| SECONDARY | Quality of Life-Short Form 12 (SF-12) Physical Health Component Score | 5 years | The Quality of Life study was performed in a subset of B-35 participants. Participants were required to have submitted a baseline and at least one follow-up QOL form to be included in the analysis. | units on a scale | MEAN |
| SECONDARY | Quality-adjusted Survival Time | 10 years | months | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Free From Breast Cancer | Group 1: Tamoxifen + Anastrozole Placebo | 89.1 | percentage of participants event-free | ||
| Percentage of Patients Free From Breast Cancer | Group 2: Anastrozole + Tamoxifen Placebo | 93.1 | percentage of participants event-free | ||
| Percentage of Patients Free From Invasive Breast Cancer | Group 1: Tamoxifen + Anastrozole Placebo | 93.3 | percentage of participants event-free | ||
| Percentage of Patients Free From Invasive Breast Cancer | Group 2: Anastrozole + Tamoxifen Placebo | 96.4 | percentage of participants event-free | ||
| Percentage of Patients Free From Ipsilateral Recurrence | Group 1: Tamoxifen + Anastrozole Placebo | 94.6 | percentage of participants event-free | ||
| Percentage of Patients Free From Ipsilateral Recurrence | Group 2: Anastrozole + Tamoxifen Placebo | 96.4 | percentage of participants event-free | ||
| Percentage of Patients Free From Contralateral Breast Cancer | Group 1: Tamoxifen + Anastrozole Placebo | 94.7 | percentage of participants event-free | ||
| Percentage of Patients Free From Contralateral Breast Cancer | Group 2: Anastrozole + Tamoxifen Placebo | 97.0 | percentage of participants event-free | ||
| Percentage of Patients Free From Non-breast Secondary Cancer | Group 1: Tamoxifen + Anastrozole Placebo | 91.5 | percentage of participants event-free | ||
| Percentage of Patients Free From Non-breast Secondary Cancer | Group 2: Anastrozole + Tamoxifen Placebo | 91.9 | percentage of participants event-free |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Tamoxifen + Anastrozole Placebo | 1,552 | |
| Overall Study | STARTED | Group 2: Anastrozole + Tamoxifen Placebo | 1,552 | |
| Overall Study | COMPLETED | Group 1: Tamoxifen + Anastrozole Placebo | 1,538 | |
| Overall Study | COMPLETED | Group 2: Anastrozole + Tamoxifen Placebo | 1,539 | |
| Overall Study | NOT COMPLETED | Group 1: Tamoxifen + Anastrozole Placebo | 14 | |
| Overall Study | NOT COMPLETED | Group 2: Anastrozole + Tamoxifen Placebo | 13 |
Source ClinicalTrials.gov
Adverse events188
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 | Group 1: Tamoxifen + Anastrozole Placebo | 358 | 1,535 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Group 2: Anastrazole + Tamoxifen Placebo | 504 | 1,535 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Group 1: Tamoxifen + Anastrozole Placebo | 96 | 1,535 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Group 2: Anastrazole + Tamoxifen Placebo | 152 | 1,535 | |
| other | Cataract | Eye disorders | Group 1: Tamoxifen + Anastrozole Placebo | 77 | 1,535 | |
| other | Cataract | Eye disorders | Group 2: Anastrazole + Tamoxifen Placebo | 43 | 1,535 | |
| other | Depression | Psychiatric disorders | Group 1: Tamoxifen + Anastrozole Placebo | 112 | 1,535 | |
| other | Depression | Psychiatric disorders | Group 2: Anastrazole + Tamoxifen Placebo | 126 | 1,535 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Group 1: Tamoxifen + Anastrozole Placebo | 101 | 1,535 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Group 2: Anastrazole + Tamoxifen Placebo | 95 | 1,535 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Tamoxifen + Anastrozole Placebo | ||
| Total, all-cause mortality | Group 2: Anastrazole + Tamoxifen Placebo | ||
| Total, other adverse events | Group 1: Tamoxifen + Anastrozole Placebo | 1,024 | 1,535 |
| Total, other adverse events | Group 2: Anastrazole + Tamoxifen Placebo | 1,064 | 1,535 |
| Total, serious adverse events | Group 1: Tamoxifen + Anastrozole Placebo | 73 | 1,535 |
| Total, serious adverse events | Group 2: Anastrazole + Tamoxifen Placebo | 62 | 1,535 |
Source ClinicalTrials.gov
Papers5
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 |
|---|
| Group 1: Tamoxifen + Anastrozole Placebo vs Group 2: Anastrazole + Tamoxifen Placebo: 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/NCT00053898
GET https://conductscience.org/api/trials/v1/NCT00053898/events?page=2