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Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Standard WBI) Arm II (WBI, Trastuzumab)
Hide Arm/Group Description

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
Arm/Group Title Standard WBI WBI, Trastuzumab Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 1008 participants 1006 participants 2014 participants
Female
1008
 100.0%
1006
 100.0%
2014
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1008 participants 1006 participants 2014 participants
American Indian or Alaska Native
5
   0.5%
5
   0.5%
10
   0.5%
Asian
33
   3.3%
43
   4.3%
76
   3.8%
Native Hawaiian or Other Pacific Islander
4
   0.4%
4
   0.4%
8
   0.4%
Black or African American
59
   5.9%
58
   5.8%
117
   5.8%
White
893
  88.6%
885
  88.0%
1778
  88.3%
More than one race
4
   0.4%
1
   0.1%
5
   0.2%
Unknown or Not Reported
10
   1.0%
10
   1.0%
20
   1.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1008 participants 1006 participants 2014 participants
Latino
45
   4.5%
47
   4.7%
92
   4.6%
Non-Latino
925
  91.8%
920
  91.5%
1845
  91.6%
Unknown
38
   3.8%
39
   3.9%
77
   3.8%
1.Primary Outcome
Title Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival
Hide Description Patients who are free from Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence or Ipsilateral DCIS as estimated by (1- cumulative incidence) x 100%.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard WBI) Arm II (WBI, Trastuzumab)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 1005 993
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients event free
95.1
(93.8 to 96.5)
96.1
(94.9 to 97.3)
2.Secondary Outcome
Title Invasive or DCIS Disease-free Survival
Hide Description 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
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard WBI) Arm II (WBI, Trastuzumab)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 1005 993
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients event free
88.4
(86.3 to 90.4)
90.6
(88.8 to 92.5)
3.Secondary Outcome
Title Invasive or DCIS Recurrence-free Interval
Hide Description 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%.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard WBI) Arm II (WBI, Trastuzumab)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 1005 993
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients event free
94.4
(92.9 to 95.8)
95.8
(94.5 to 97.1)
4.Secondary Outcome
Title Invasive Regional or Distant-Free Recurrence
Hide Description

Percentage of patients who are free of invasive regional or distant recurrence as estimated by

(1 - cumulative incidence) x 100%.

Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard WBI) Arm II (WBI, Trastuzumab)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 1005 993
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients event free
99.9
(99.7 to 100.0)
99.9
(99.7 to 100.0)
5.Secondary Outcome
Title Contralateral Breast Cancer (Invasive or DCIS) - Free Survival
Hide Description

Percentage of patients free of Contralateral Breast Cancer (Invasive or DCIS) as estimated by

(1- cumulative incidence) x 100%.

Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard WBI) Arm II (WBI, Trastuzumab)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 1005 993
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients event free
97.9
(97.0 to 98.8)
98.4
(97.6 to 99.2)
6.Secondary Outcome
Title Overall Survival
Hide Description Percentage of patients surviving as estimated by a Kaplan-Meier
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard WBI) Arm II (WBI, Trastuzumab)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 1005 993
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients surviving
98.9
(98.2 to 99.5)
99.0
(98.3 to 99.6)
7.Secondary Outcome
Title Incidence of Post-treatment Amenorrhea in Women Who Were Premenopausal at the Time of Study Entry Premenopausal at the Time of Study Entry
Hide Description Proportion of patients who were pre-menopausal at randomization and who self-reported as not having menstrual periods afterwards
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who reported being postmenopausal at randomization who later self-reported as yes or no to whether or not they had menstrual periods.
Arm/Group Title Arm I (Standard WBI) Arm II (WBI, Trastuzumab)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 126 121
Measure Type: Number
Unit of Measure: percentage of participants
63 72
Time Frame All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose.
Adverse Event Reporting Description All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
 
Arm/Group Title Standard WBI WBI, Trastuzumab
Hide Arm/Group Description standard WBI WBI, trastuzumab
All-Cause Mortality
Standard WBI WBI, Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   11/1005 (1.09%)   10/993 (1.01%) 
Hide Serious Adverse Events
Standard WBI WBI, Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   3/998 (0.30%)   9/990 (0.91%) 
Cardiac disorders     
Atrial flutter  1  0/998 (0.00%)  1/990 (0.10%) 
Myocardial infarction  1  1/998 (0.10%)  0/990 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/998 (0.00%)  1/990 (0.10%) 
Hepatobiliary disorders     
Cholecystitis  1  0/998 (0.00%)  1/990 (0.10%) 
Infections and infestations     
Urinary tract infection  1  0/998 (0.00%)  1/990 (0.10%) 
Lung infection  1  0/998 (0.00%)  1/990 (0.10%) 
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications - Other, specify  1  0/998 (0.00%)  1/990 (0.10%) 
Investigations     
Cardiac troponin I increased  1  1/998 (0.10%)  0/990 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/998 (0.00%)  1/990 (0.10%) 
Hyperglycemia  1  0/998 (0.00%)  1/990 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  0/998 (0.00%)  1/990 (0.10%) 
Leukemia secondary to oncology chemotherapy  1  1/998 (0.10%)  0/990 (0.00%) 
Treatment related secondary malignancy  1  2/998 (0.20%)  1/990 (0.10%) 
Vascular disorders     
Hypotension  1  0/998 (0.00%)  1/990 (0.10%) 
Thromboembolic event  1  0/998 (0.00%)  1/990 (0.10%) 
1
Term from vocabulary, CTCAE v4.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard WBI WBI, Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   292/998 (29.26%)   254/990 (25.66%) 
General disorders     
Fatigue  1  80/998 (8.02%)  77/990 (7.78%) 
Injury, poisoning and procedural complications     
Dermatitis radiation  1  261/998 (26.15%)  208/990 (21.01%) 
1
Term from vocabulary, CTCAE v4.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Department of Regulatory Affairs
Organization: NRG Oncology
Phone: 412-339-5300
EMail: langerj@nrgoncology.org
Layout table for additonal information
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