Trial Outcomes & Findings for 4D Image-Guided Partial Breast Radiation in Stage 0 and l Breast Cancer (NCT NCT01646346)

Last Updated: 2018-11-23

Results Overview

Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

5 day

Results posted on

2018-11-23

Participant Flow

54 people were recruited to take part, however only 46 of those were treated and included in the study.

Participant milestones

Participant milestones
Measure	4D Conformal Image-Guided Partial Breast RT 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 Study STARTED	46
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4D Conformal Image-Guided Partial Breast RT n=46 Participants 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.
Age, Continuous	64.0 years n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 day

Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.

Outcome measures

Outcome measures
Measure	4D Conformal Image-Guided Partial Breast RT n=46 Participants 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.
Patients With Reduction in Incidental Radiation	46 Participants

SECONDARY outcome

Timeframe: Within no more than 8 weeks of surgery, but prior to the start of radiation

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.

Outcome measures

Outcome measures
Measure	4D Conformal Image-Guided Partial Breast RT n=46 Participants 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.
Cosmesis by Patient Report	4 units on a scale Interval 0.0 to 16.0

SECONDARY outcome

Timeframe: 1 year post treatment

Outcome measures

Outcome measures
Measure	4D Conformal Image-Guided Partial Breast RT n=43 Participants 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.
Cosmesis by Patient Report	8.5 units on a scale Interval 1.0 to 20.0

SECONDARY outcome

Timeframe: 3 year post treatment

Outcome measures

Outcome measures
Measure	4D Conformal Image-Guided Partial Breast RT n=39 Participants 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.
Cosmesis by Patient Report	7.0 units on a scale Interval 0.0 to 29.0

SECONDARY outcome

Timeframe: Within no more than 8 weeks of surgery, but prior to the start of radiation

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.

Outcome measures

Outcome measures
Measure	4D Conformal Image-Guided Partial Breast RT n=46 Participants 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.
Cosmesis by Medical Doctor Report excellent	41 Participants
Cosmesis by Medical Doctor Report good	4 Participants
Cosmesis by Medical Doctor Report fair	1 Participants
Cosmesis by Medical Doctor Report poor	0 Participants

SECONDARY outcome

Timeframe: 1 yr post treatment

Outcome measures

Outcome measures
Measure	4D Conformal Image-Guided Partial Breast RT n=43 Participants 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.
Cosmesis by Medical Doctor Report excellent	20 Participants
Cosmesis by Medical Doctor Report good	20 Participants
Cosmesis by Medical Doctor Report fair	3 Participants
Cosmesis by Medical Doctor Report poor	0 Participants

SECONDARY outcome

Timeframe: 3 yr post treatment

Outcome measures

Outcome measures
Measure	4D Conformal Image-Guided Partial Breast RT n=39 Participants 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.
Cosmesis by Medical Doctor Report excellent	16 Participants
Cosmesis by Medical Doctor Report good	17 Participants
Cosmesis by Medical Doctor Report fair	5 Participants
Cosmesis by Medical Doctor Report poor	1 Participants

Adverse Events

4D Conformal Image-Guided Partial Breast RT

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	4D Conformal Image-Guided Partial Breast RT n=46 participants at risk 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.
Gastrointestinal disorders Abdominal pain	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
Gastrointestinal disorders Nausea	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
General disorders Fatigue	30.4% 14/46 • Number of events 15 • Through treatment completion, and up to 3 years follow up.
General disorders General disorders and administration site conditions	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
General disorders Localized edema	30.4% 14/46 • Number of events 15 • Through treatment completion, and up to 3 years follow up.
General disorders Non-cardiac chest pain	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
General disorders Pain	6.5% 3/46 • Number of events 3 • Through treatment completion, and up to 3 years follow up.
Injury, poisoning and procedural complications Bruising	4.3% 2/46 • Number of events 3 • Through treatment completion, and up to 3 years follow up.
Injury, poisoning and procedural complications Dermatitis radiation	54.3% 25/46 • Number of events 31 • Through treatment completion, and up to 3 years follow up.
Injury, poisoning and procedural complications Seroma	21.7% 10/46 • Number of events 12 • Through treatment completion, and up to 3 years follow up.
Musculoskeletal and connective tissue disorders Arthralgia	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
Musculoskeletal and connective tissue disorders Chest wall pain	4.3% 2/46 • Number of events 2 • Through treatment completion, and up to 3 years follow up.
Injury, poisoning and procedural complications Superficial soft tissue fibrosis	89.1% 41/46 • Number of events 57 • Through treatment completion, and up to 3 years follow up.
Nervous system disorders Nervous system disorders - Other	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
Reproductive system and breast disorders Breast pain	28.3% 13/46 • Number of events 16 • Through treatment completion, and up to 3 years follow up.
Respiratory, thoracic and mediastinal disorders Cough	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.5% 3/46 • Number of events 3 • Through treatment completion, and up to 3 years follow up.
Skin and subcutaneous tissue disorders Fat atrophy	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
Skin and subcutaneous tissue disorders Pruritus	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	10.9% 5/46 • Number of events 7 • Through treatment completion, and up to 3 years follow up.
Skin and subcutaneous tissue disorders Skin atrophy	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	82.6% 38/46 • Number of events 51 • Through treatment completion, and up to 3 years follow up.
Skin and subcutaneous tissue disorders Skin hypopigmentation	4.3% 2/46 • Number of events 2 • Through treatment completion, and up to 3 years follow up.
Skin and subcutaneous tissue disorders Skin induration	8.7% 4/46 • Number of events 4 • Through treatment completion, and up to 3 years follow up.
Skin and subcutaneous tissue disorders Telangiectasia	10.9% 5/46 • Number of events 6 • Through treatment completion, and up to 3 years follow up.
Vascular disorders Thromboembolic event	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.
Skin and subcutaneous tissue disorders Ecchymosis	2.2% 1/46 • Number of events 1 • Through treatment completion, and up to 3 years follow up.

Additional Information

Dr. Suzanne Evans, MD, MPH

Yale University

Phone: (203) 785-5175

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place