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4D Image-Guided Partial Breast Radiation in Stage 0 and l Breast Cancer

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ClinicalTrials.gov Identifier: NCT01646346
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Radiation: 4D Conformal Image-Guided Partial Breast RT
Enrollment 46
Recruitment Details 54 people were recruited to take part, however only 46 of those were treated and included in the study.
Pre-assignment Details  
Arm/Group Title 4D Conformal Image-Guided Partial Breast RT
Hide Arm/Group Description

This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.

4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.

Period Title: Overall Study
Started 46
Completed 46
Not Completed 0
Arm/Group Title 4D Conformal Image-Guided Partial Breast RT
Hide Arm/Group Description

This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.

4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.

Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 46 participants
64.0
(50 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
46
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Hispanic or Latino
1
   2.2%
Not Hispanic or Latino
45
  97.8%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Patients With Reduction in Incidental Radiation
Hide Description Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.
Time Frame 5 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 4D Conformal Image-Guided Partial Breast RT
Hide Arm/Group Description:

This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.

4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.

Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
46
 100.0%
2.Secondary Outcome
Title Cosmesis by Patient Report
Hide Description This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.
Time Frame Within no more than 8 weeks of surgery, but prior to the start of radiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 4D Conformal Image-Guided Partial Breast RT
Hide Arm/Group Description:

This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.

4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.

Overall Number of Participants Analyzed 46
Median (Full Range)
Unit of Measure: units on a scale
4
(0 to 16)
3.Secondary Outcome
Title Cosmesis by Patient Report
Hide Description This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.
Time Frame 1 year post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 4D Conformal Image-Guided Partial Breast RT
Hide Arm/Group Description:

This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.

4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.

Overall Number of Participants Analyzed 43
Median (Full Range)
Unit of Measure: units on a scale
8.5
(1 to 20)
4.Secondary Outcome
Title Cosmesis by Patient Report
Hide Description This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.
Time Frame 3 year post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 4D Conformal Image-Guided Partial Breast RT
Hide Arm/Group Description:

This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.

4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.

Overall Number of Participants Analyzed 39
Median (Full Range)
Unit of Measure: units on a scale
7.0
(0 to 29)
5.Secondary Outcome
Title Cosmesis by Medical Doctor Report
Hide Description Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.
Time Frame Within no more than 8 weeks of surgery, but prior to the start of radiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 4D Conformal Image-Guided Partial Breast RT
Hide Arm/Group Description:

This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.

4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.

Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
excellent
41
  89.1%
good
4
   8.7%
fair
1
   2.2%
poor
0
   0.0%
6.Secondary Outcome
Title Cosmesis by Medical Doctor Report
Hide Description Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.
Time Frame 1 yr post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 4D Conformal Image-Guided Partial Breast RT
Hide Arm/Group Description:

This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.

4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.

Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
excellent
20
  46.5%
good
20
  46.5%
fair
3
   7.0%
poor
0
   0.0%
7.Secondary Outcome
Title Cosmesis by Medical Doctor Report
Hide Description Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.
Time Frame 3 yr post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 4D Conformal Image-Guided Partial Breast RT
Hide Arm/Group Description:

This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.

4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.

Overall Number of Participants Analyzed 39
Measure Type: Count of Participants
Unit of Measure: Participants
excellent
16
  41.0%
good
17
  43.6%
fair
5
  12.8%
poor
1
   2.6%
Time Frame Through treatment completion, and up to 3 years follow up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 4D Conformal Image-Guided Partial Breast RT
Hide Arm/Group Description

This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.

4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.

All-Cause Mortality
4D Conformal Image-Guided Partial Breast RT
Affected / at Risk (%)
Total   0/46 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
4D Conformal Image-Guided Partial Breast RT
Affected / at Risk (%) # Events
Total   0/46 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
4D Conformal Image-Guided Partial Breast RT
Affected / at Risk (%) # Events
Total   45/46 (97.83%)    
Gastrointestinal disorders   
Abdominal pain  1  1/46 (2.17%)  1
Nausea  1  1/46 (2.17%)  1
General disorders   
Fatigue  1  14/46 (30.43%)  15
General disorders and administration site conditions  1  1/46 (2.17%)  1
Localized edema  1  14/46 (30.43%)  15
Non-cardiac chest pain  1  1/46 (2.17%)  1
Pain  1  3/46 (6.52%)  3
Injury, poisoning and procedural complications   
Bruising  1  2/46 (4.35%)  3
Dermatitis radiation  1  25/46 (54.35%)  31
Seroma  1  10/46 (21.74%)  12
Superficial soft tissue fibrosis  1  41/46 (89.13%)  57
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/46 (2.17%)  1
Chest wall pain  1  2/46 (4.35%)  2
Nervous system disorders   
Nervous system disorders - Other  1  1/46 (2.17%)  1
Reproductive system and breast disorders   
Breast pain  1  13/46 (28.26%)  16
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/46 (2.17%)  1
Dyspnea  1  3/46 (6.52%)  3
Skin and subcutaneous tissue disorders   
Fat atrophy  1  1/46 (2.17%)  1
Pruritus  1  1/46 (2.17%)  1
Rash maculo-papular  1  1/46 (2.17%)  1
Skin and subcutaneous tissue disorders - Other  1  5/46 (10.87%)  7
Skin atrophy  1  1/46 (2.17%)  1
Skin hyperpigmentation  1  38/46 (82.61%)  51
Skin hypopigmentation  1  2/46 (4.35%)  2
Skin induration  1  4/46 (8.70%)  4
Telangiectasia  1  5/46 (10.87%)  6
Ecchymosis  1  1/46 (2.17%)  1
Vascular disorders   
Thromboembolic event  1  1/46 (2.17%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Suzanne Evans, MD, MPH
Organization: Yale University
Phone: (203) 785-5175
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01646346     History of Changes
Other Study ID Numbers: 1110009173
First Submitted: March 11, 2012
First Posted: July 20, 2012
Results First Submitted: September 13, 2018
Results First Posted: November 22, 2018
Last Update Posted: November 22, 2018