Trial Outcomes & Findings for Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer (NCT NCT01266642)
NCT ID: NCT01266642
Last Updated: 2025-08-17
Results Overview
BCTOS cosmesis score range from 1 to 4, and scores of 2.5 or more indicate adverse cosmetic outcomes.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
301 participants
Primary outcome timeframe
3 years after completing radiation therapy
Results posted on
2025-08-17
Participant Flow
Participants were recruited from provider clinics at 3 academic medical centers between February 2011 and February 2014. Women with stage 0 to II breast cancer were randomly assigned to CF-WBI or HF-WBI, stratified by chemotherapy, margin status, cosmesis, and breast size.
Of the 301 participants enrolled, 287 were fully eligible and were randomized to protocol, 13 were excluded (8) Insurance would not cover protocol therapy, (4) withdrew consent and (1) became ineligible due to finding of other primary cancer on simulation CT. 1 participant was registered twice.
Participant milestones
| Measure |
CF-WBI
50 Gy in 25 fractions to the whole breast, plus a tumor bed boost of 10Gy in 5 fractions or of 14Gy in 7 fractions (dependent on surgical margins).
|
HF-WBI
42.56 Gy in 16 fractions to the whole breast, plus tumor bed boost of 10Gy in 4 fractions or 12.5Gy in 5 fractions (dependent on surgical margins).
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
138
|
|
Overall Study
COMPLETED
|
149
|
137
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
CF-WBI
50 Gy in 25 fractions to the whole breast, plus a tumor bed boost of 10Gy in 5 fractions or of 14Gy in 7 fractions (dependent on surgical margins).
|
HF-WBI
42.56 Gy in 16 fractions to the whole breast, plus tumor bed boost of 10Gy in 4 fractions or 12.5Gy in 5 fractions (dependent on surgical margins).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer
Baseline characteristics by cohort
| Measure |
CF-WBI
n=149 Participants
50 Gy in 25 fractions to the whole breast, plus a tumor bed boost of 10Gy in 5 fractions or of 14Gy in 7 fractions (dependent on surgical margins).
|
HF-WBI
n=138 Participants
42.56 Gy in 16 fractions to the whole breast, plus tumor bed boost of 10Gy in 4 fractions or 12.5Gy in 5 fractions (dependent on surgical margins).
|
Total
n=287 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 8 • n=5 Participants
|
60 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
287 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
133 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
149 participants
n=5 Participants
|
138 participants
n=7 Participants
|
287 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 years after completing radiation therapyPopulation: Intent to treat population (all participants assigned to CF-WBI or HF-WBI).
BCTOS cosmesis score range from 1 to 4, and scores of 2.5 or more indicate adverse cosmetic outcomes.
Outcome measures
| Measure |
CF-WBI
n=149 Participants
50 Gy in 25 fractions to the whole breast, plus a tumor bed boost of 10Gy in 5 fractions or of 14Gy in 7 fractions (dependent on surgical margins).
|
HF-WBI
n=138 Participants
42.56 Gy in 16 fractions to the whole breast, plus tumor bed boost of 10Gy in 4 fractions or 12.5Gy in 5 fractions (dependent on surgical margins).
|
|---|---|---|
|
Number of Participants With Scores of Either <2.5 or >=2.5 on the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis
BCTOS cosmesis < 2.5
|
97 Participants
|
88 Participants
|
|
Number of Participants With Scores of Either <2.5 or >=2.5 on the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis
BCTOS cosmesis >= 2.5
|
17 Participants
|
15 Participants
|
|
Number of Participants With Scores of Either <2.5 or >=2.5 on the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis
Unknown
|
35 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 3 years after completing radiation therapy.Population: Intent to treat population (all participants assigned to CF-WBI or HF-WBI).
A group of three attending physicians blinded to the treatment scored the photographs using the Radiation Therapy and Oncology Group (RTOG) criteria. RTOG scale range from 1 (excellent), 2 (good), 3 (fair), and 4 (poor).
Outcome measures
| Measure |
CF-WBI
n=149 Participants
50 Gy in 25 fractions to the whole breast, plus a tumor bed boost of 10Gy in 5 fractions or of 14Gy in 7 fractions (dependent on surgical margins).
|
HF-WBI
n=138 Participants
42.56 Gy in 16 fractions to the whole breast, plus tumor bed boost of 10Gy in 4 fractions or 12.5Gy in 5 fractions (dependent on surgical margins).
|
|---|---|---|
|
Panel Physicians Rated Cosmesis
Excellent/Good
|
86 Participants
|
72 Participants
|
|
Panel Physicians Rated Cosmesis
Fair/Poor
|
28 Participants
|
31 Participants
|
|
Panel Physicians Rated Cosmesis
Unknown
|
35 Participants
|
35 Participants
|
Adverse Events
CF-WBI
Serious events: 0 serious events
Other events: 149 other events
Deaths: 0 deaths
HF-WBI
Serious events: 0 serious events
Other events: 138 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CF-WBI
n=149 participants at risk
50 Gy in 25 fractions to the whole breast, plus a tumor bed boost of 10Gy in 5 fractions or of 14Gy in 7 fractions (dependent on surgical margins).
|
HF-WBI
n=138 participants at risk
42.56 Gy in 16 fractions to the whole breast, plus tumor bed boost of 10Gy in 4 fractions or 12.5Gy in 5 fractions (dependent on surgical margins).
|
|---|---|---|
|
General disorders
Fatigue
|
90.6%
135/149 • From the time radiotherapy was completed until 5-years post treatment.
|
82.6%
114/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
88.6%
132/149 • From the time radiotherapy was completed until 5-years post treatment.
|
79.0%
109/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
26.2%
39/149 • From the time radiotherapy was completed until 5-years post treatment.
|
32.6%
45/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
99.3%
148/149 • From the time radiotherapy was completed until 5-years post treatment.
|
94.2%
130/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
11.4%
17/149 • From the time radiotherapy was completed until 5-years post treatment.
|
13.0%
18/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Vascular disorders
Lymphedema
|
8.1%
12/149 • From the time radiotherapy was completed until 5-years post treatment.
|
5.1%
7/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
59.7%
89/149 • From the time radiotherapy was completed until 5-years post treatment.
|
57.2%
79/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
33.6%
50/149 • From the time radiotherapy was completed until 5-years post treatment.
|
37.0%
51/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Injury, poisoning and procedural complications
Seroma
|
24.2%
36/149 • From the time radiotherapy was completed until 5-years post treatment.
|
29.0%
40/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
82.6%
123/149 • From the time radiotherapy was completed until 5-years post treatment.
|
72.5%
100/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
9/149 • From the time radiotherapy was completed until 5-years post treatment.
|
6.5%
9/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nipple deformity
|
40.9%
61/149 • From the time radiotherapy was completed until 5-years post treatment.
|
35.5%
49/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Reproductive system and breast disorders
Breast atrophy
|
70.5%
105/149 • From the time radiotherapy was completed until 5-years post treatment.
|
69.6%
96/138 • From the time radiotherapy was completed until 5-years post treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
80.5%
120/149 • From the time radiotherapy was completed until 5-years post treatment.
|
54.3%
75/138 • From the time radiotherapy was completed until 5-years post treatment.
|
Additional Information
Dr. Benjamin Smith, Professor, Radiation Oncology Department
UT MD Anderson Cancer Center
Phone: (713) 563-2380
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place