Trial · NCT00769379
Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy
NCT00769379, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2022-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy. Trials, record NCT00769379. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00769379
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy
- NCT number
- NCT00769379
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,014 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Breast Ductal Carcinoma In Situ
- Interventions
- Laboratory Biomarker Analysis, Trastuzumab, Whole Breast Irradiation
- First posted
- 2008-10-09
- Last updated
- 2025-06-12
- Results first posted
- 2022-02-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival | 5 years | Patients who are free from Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence or Ipsilateral DCIS as estimated by (1- cumulative incidence) x 100%. |
| Secondary | Invasive or DCIS Disease-free Survival | 5 years | Events for analysis of IDFS-DCIS include: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous and basal cell carcinoma of the skin, melanoma in situ, and carcinoma in situ of the colon and cervix), or death from any cause prior to recurrence or second primary cancer. Invasive breast cancer, ipsilateral recurrence, and contralateral breast cancer will be compared across treatment arms using cumulative incidence functions. Percentage of patients by a Kaplan-Meier analysis who are free of invasive or DCIS disease |
| Secondary | Invasive or DCIS Recurrence-free Interval | 5 years | Cox proportional hazards models will be used to evaluate the effect of treatment on time to event. The distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests. Compared across treatment arms using cumulative incidence functions.Percentage of patients who are invasive or DCIS recurrence free estimated by (1-cumulative incidence) x 100%. |
| Secondary | Invasive Regional or Distant-Free Recurrence | 5 years | Percentage of patients who are free of invasive regional or distant recurrence as estimated by (1 - cumulative incidence) x 100%. |
| Secondary | Contralateral Breast Cancer (Invasive or DCIS) - Free Survival | 5 years | Percentage of patients free of Contralateral Breast Cancer (Invasive or DCIS) as estimated by (1- cumulative incidence) x 100%. |
| Secondary | Overall Survival | 5 years | Percentage of patients surviving as estimated by a Kaplan-Meier |
| Secondary | Incidence of Post-treatment Amenorrhea in Women Who Were Premenopausal at the Time of Study Entry Premenopausal at the Time of Study Entry | 18 months | Proportion of patients who were pre-menopausal at randomization and who self-reported as not having menstrual periods afterwards |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival | 5 years | percentage of patients event free | NUMBER | |
| SECONDARY | Invasive or DCIS Disease-free Survival | 5 years | percentage of patients event free | NUMBER | |
| SECONDARY | Invasive or DCIS Recurrence-free Interval | 5 years | percentage of patients event free | NUMBER | |
| SECONDARY | Invasive Regional or Distant-Free Recurrence | 5 years | percentage of patients event free | NUMBER | |
| SECONDARY | Contralateral Breast Cancer (Invasive or DCIS) - Free Survival | 5 years | percentage of patients event free | NUMBER | |
| SECONDARY | Overall Survival | 5 years | percentage of patients surviving | NUMBER | |
| SECONDARY | Incidence of Post-treatment Amenorrhea in Women Who Were Premenopausal at the Time of Study Entry Premenopausal at the Time of Study Entry | 18 months | All patients who reported being postmenopausal at randomization who later self-reported as yes or no to whether or not they had menstrual periods. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival | Arm I (Standard WBI) | 95.1 | 95% Confidence Interval 93.8 to 96.5 | percentage of patients event free | |
| Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival | Arm II (WBI, Trastuzumab) | 96.1 | 95% Confidence Interval 94.9 to 97.3 | percentage of patients event free | |
| Invasive or DCIS Disease-free Survival | Arm I (Standard WBI) | 88.4 | 95% Confidence Interval 86.3 to 90.4 | percentage of patients event free | |
| Invasive or DCIS Disease-free Survival | Arm II (WBI, Trastuzumab) | 90.6 | 95% Confidence Interval 88.8 to 92.5 | percentage of patients event free | |
| Invasive or DCIS Recurrence-free Interval | Arm I (Standard WBI) | 94.4 | 95% Confidence Interval 92.9 to 95.8 | percentage of patients event free | |
| Invasive or DCIS Recurrence-free Interval | Arm II (WBI, Trastuzumab) | 95.8 | 95% Confidence Interval 94.5 to 97.1 | percentage of patients event free | |
| Invasive Regional or Distant-Free Recurrence | Arm I (Standard WBI) | 99.9 | 95% Confidence Interval 99.7 to 100.0 | percentage of patients event free | |
| Invasive Regional or Distant-Free Recurrence | Arm II (WBI, Trastuzumab) | 99.9 | 95% Confidence Interval 99.7 to 100.0 | percentage of patients event free | |
| Contralateral Breast Cancer (Invasive or DCIS) - Free Survival | Arm I (Standard WBI) | 97.9 | 95% Confidence Interval 97.0 to 98.8 | percentage of patients event free | |
| Contralateral Breast Cancer (Invasive or DCIS) - Free Survival | Arm II (WBI, Trastuzumab) | 98.4 | 95% Confidence Interval 97.6 to 99.2 | percentage of patients event free |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Standard WBI) | 1,008 | |
| Overall Study | STARTED | Arm II (WBI, Trastuzumab) | 1,006 | |
| Overall Study | COMPLETED | Arm I (Standard WBI) | 1,005 | |
| Overall Study | COMPLETED | Arm II (WBI, Trastuzumab) | 993 | |
| Overall Study | NOT COMPLETED | Arm I (Standard WBI) | 3 | |
| Overall Study | NOT COMPLETED | Arm II (WBI, Trastuzumab) | 13 |
Source ClinicalTrials.gov
Adverse events34
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 | Fatigue | General disorders | Standard WBI | 80 | 998 | |
| other | Fatigue | General disorders | WBI, Trastuzumab | 77 | 990 | |
| other | Dermatitis radiation | Injury, poisoning and procedural complications | Standard WBI | 261 | 998 | |
| other | Dermatitis radiation | Injury, poisoning and procedural complications | WBI, Trastuzumab | 208 | 990 | |
| serious | Atrial flutter | Cardiac disorders | Standard WBI | 0 | 998 | |
| serious | Atrial flutter | Cardiac disorders | WBI, Trastuzumab | 1 | 990 | |
| serious | Cardiac troponin I increased | Investigations | Standard WBI | 1 | 998 | |
| serious | Cardiac troponin I increased | Investigations | WBI, Trastuzumab | 0 | 990 | |
| serious | Cholecystitis | Hepatobiliary disorders | Standard WBI | 0 | 998 | |
| serious | Cholecystitis | Hepatobiliary disorders | WBI, Trastuzumab | 1 | 990 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard WBI | 11 | 1,005 |
| Total, all-cause mortality | WBI, Trastuzumab | 10 | 993 |
| Total, other adverse events | Standard WBI | 292 | 998 |
| Total, other adverse events | WBI, Trastuzumab | 254 | 990 |
| Total, serious adverse events | Standard WBI | 3 | 998 |
| Total, serious adverse events | WBI, Trastuzumab | 9 | 990 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants3
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| UG1CA189867 | NRG Oncology NCORP Research Base-BIQSFP | BRUNER, DEBORAH WATKINS; WALKER, JOAN LESLIE | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| U10CA012027 | NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT | WOLMARK, NORMAN | NSABP FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 1985 to 2012 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard WBI vs WBI, Trastuzumab: deaths from any cause | Trial comparisons |
| Standard WBI vs WBI, Trastuzumab: 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/NCT00769379
GET https://conductscience.org/api/trials/v1/NCT00769379/events?page=2