Trial · NCT00005957
Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
NCT00005957, Not applicable, Completed, NCIC Clinical Trials Group; results first posted 2016-06-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer. Trials, record NCT00005957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00005957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
- NCT number
- NCT00005957
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,832 participants, actual
- Lead sponsor
- NCIC Clinical Trials Group
- Conditions
- Breast Cancer
- Interventions
- Standard Breast Irradiation, Breast Radiation plus Regional Radiation
- First posted
- 2003-01-27
- Last updated
- 2023-08-21
- Results first posted
- 2016-06-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 10 years | Duration of study |
| Secondary | Disease-free Survival | 10 years | Disease-free survival (including locoregional and distant disease) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | 10 years | Intention-to-treat | percentage of alive at 10 years | NUMBER |
| SECONDARY | Disease-free Survival | 10 years | Intention-to-treat | percentage of disease-free at 10 years | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Standard Breast Irradiation | 82 | 95% Confidence Interval 79 to 84 | percentage of alive at 10 years | |
| Overall Survival | Breast Radiation Plus Regional Radiation | 83 | 95% Confidence Interval 80 to 85 | percentage of alive at 10 years | |
| Disease-free Survival | Standard Breast Irradiation | 77 | 95% Confidence Interval 74 to 80 | percentage of disease-free at 10 years | |
| Disease-free Survival | Breast Radiation Plus Regional Radiation | 82 | 95% Confidence Interval 79 to 85 | percentage of disease-free at 10 years |
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 | Standard Breast Irradiation | 916 | |
| Overall Study | STARTED | Breast Radiation Plus Regional Radiation | 916 | |
| Overall Study | COMPLETED | Standard Breast Irradiation | 908 | |
| Overall Study | COMPLETED | Breast Radiation Plus Regional Radiation | 888 | |
| Overall Study | NOT COMPLETED | Standard Breast Irradiation | 8 | |
| Overall Study | NOT COMPLETED | Breast Radiation Plus Regional Radiation | 28 |
Source ClinicalTrials.gov
Adverse events32
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 | Lymphedema | Blood and lymphatic system disorders | Standard Breast Irradiation | 180 | 927 | |
| other | Lymphedema | Blood and lymphatic system disorders | Breast Radiation Plus Regional Radiation | 226 | 893 | |
| other | Fatigue | General disorders | Standard Breast Irradiation | 353 | 927 | |
| other | Fatigue | General disorders | Breast Radiation Plus Regional Radiation | 343 | 893 | |
| other | Pain due to radiation | General disorders | Standard Breast Irradiation | 252 | 927 | |
| other | Pain due to radiation | General disorders | Breast Radiation Plus Regional Radiation | 233 | 893 | |
| other | Joint | General disorders | Standard Breast Irradiation | 69 | 927 | |
| other | Joint | General disorders | Breast Radiation Plus Regional Radiation | 89 | 893 | |
| other | Skin | General disorders | Standard Breast Irradiation | 313 | 927 | |
| other | Skin | General disorders | Breast Radiation Plus Regional Radiation | 316 | 893 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Breast Irradiation | ||
| Total, all-cause mortality | Breast Radiation Plus Regional Radiation | ||
| Total, other adverse events | Standard Breast Irradiation | 745 | 927 |
| Total, other adverse events | Breast Radiation Plus Regional Radiation | 752 | 893 |
| Total, serious adverse events | Standard Breast Irradiation | 1 | 927 |
| Total, serious adverse events | Breast Radiation Plus Regional Radiation | 3 | 893 |
Source ClinicalTrials.gov
Papers2
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 |
|---|
| Standard Breast Irradiation vs Breast Radiation Plus Regional Radiation: 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/NCT00005957
GET https://conductscience.org/api/trials/v1/NCT00005957/events?page=2