Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy
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ClinicalTrials.gov Identifier: NCT00769379 |
Recruitment Status :
Active, not recruiting
First Posted : October 9, 2008
Results First Posted : February 23, 2022
Last Update Posted : May 2, 2022
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Sponsor:
National Cancer Institute (NCI)
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Breast Ductal Carcinoma In Situ |
Interventions |
Other: Laboratory Biomarker Analysis Biological: Trastuzumab Radiation: Whole Breast Irradiation |
Enrollment | 2014 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Arm I (Standard WBI) | Arm II (WBI, Trastuzumab) |
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Patients undergo standard WBI over 5-6 weeks. Laboratory Biomarker Analysis: Correlative studies Whole Breast Irradiation: Undergo standard whole breast irradiation |
Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. Laboratory Biomarker Analysis: Correlative studies Trastuzumab: Given IV Whole Breast Irradiation: Undergo standard whole breast irradiation |
Period Title: Overall Study | ||
Started | 1008 | 1006 |
Completed | 1005 | 993 |
Not Completed | 3 | 13 |
Reason Not Completed | ||
No follow up data mapped to Other. | 3 | 13 |
Baseline Characteristics
Arm/Group Title | Standard WBI | WBI, Trastuzumab | Total | |
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Standard WBI (Radiation Therapy) | WBI, trastuzumab (Radiation Therapy + Trastuzumab x 2 doses. Dose 1: 8 mg/kg IV Dose 2: 6 mg/kg IV-given 3 weeks after dose 1 | Total of all reporting groups | |
Overall Number of Baseline Participants | 1008 | 1006 | 2014 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 1008 participants | 1006 participants | 2014 participants | |
56 (9.3) | 56 (8.7) | 56 (9.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1008 participants | 1006 participants | 2014 participants | |
Female |
1008 100.0%
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1006 100.0%
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2014 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1008 participants | 1006 participants | 2014 participants | |
American Indian or Alaska Native |
5 0.5%
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5 0.5%
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10 0.5%
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Asian |
33 3.3%
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43 4.3%
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76 3.8%
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Native Hawaiian or Other Pacific Islander |
4 0.4%
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4 0.4%
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8 0.4%
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Black or African American |
59 5.9%
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58 5.8%
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117 5.8%
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White |
893 88.6%
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885 88.0%
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1778 88.3%
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More than one race |
4 0.4%
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1 0.1%
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5 0.2%
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Unknown or Not Reported |
10 1.0%
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10 1.0%
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20 1.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 1008 participants | 1006 participants | 2014 participants |
Latino |
45 4.5%
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47 4.7%
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92 4.6%
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Non-Latino |
925 91.8%
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920 91.5%
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1845 91.6%
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Unknown |
38 3.8%
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39 3.9%
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77 3.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Director, Department of Regulatory Affairs |
Organization: | NRG Oncology |
Phone: | 412-339-5300 |
EMail: | langerj@nrgoncology.org |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00769379 |
Other Study ID Numbers: |
NCI-2009-00702 NCI-2009-00702 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000615085 B-43 NSABP-B-43 ( Other Identifier: NRG Oncology ) NSABP-B-43 ( Other Identifier: CTEP ) U10CA012027 ( U.S. NIH Grant/Contract ) U10CA180868 ( U.S. NIH Grant/Contract ) |
First Submitted: | October 8, 2008 |
First Posted: | October 9, 2008 |
Results First Submitted: | March 23, 2021 |
Results First Posted: | February 23, 2022 |
Last Update Posted: | May 2, 2022 |