Trial Outcomes & Findings for Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer (NCT NCT00005957)
NCT ID: NCT00005957
Last Updated: 2023-08-21
Results Overview
Duration of study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1832 participants
Primary outcome timeframe
10 years
Results posted on
2023-08-21
Participant Flow
Participant milestones
| Measure |
Standard Breast Irradiation
radiation therapy: Standard Breast Irradiation - A dose of 5000 centigray (cGy) in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
|
Breast Radiation Plus Regional Radiation
regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
|
|---|---|---|
|
Overall Study
STARTED
|
916
|
916
|
|
Overall Study
COMPLETED
|
908
|
888
|
|
Overall Study
NOT COMPLETED
|
8
|
28
|
Reasons for withdrawal
| Measure |
Standard Breast Irradiation
radiation therapy: Standard Breast Irradiation - A dose of 5000 centigray (cGy) in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
|
Breast Radiation Plus Regional Radiation
regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
|
|---|---|---|
|
Overall Study
No treated
|
3
|
9
|
|
Overall Study
Crossover to the other arm
|
5
|
19
|
Baseline Characteristics
Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
Baseline characteristics by cohort
| Measure |
Standard Breast Irradiation
n=916 Participants
radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
|
Breast Radiation Plus Regional Radiation
n=916 Participants
regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
|
Total
n=1832 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 10 • n=5 Participants
|
54 years
STANDARD_DEVIATION 10 • n=7 Participants
|
54 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
916 Participants
n=5 Participants
|
916 Participants
n=7 Participants
|
1832 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: Intention-to-treat
Duration of study
Outcome measures
| Measure |
Standard Breast Irradiation
n=916 Participants
radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
|
Breast Radiation Plus Regional Radiation
n=916 Participants
regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
|
|---|---|---|
|
Overall Survival
|
82 percentage of alive at 10 years
Interval 79.0 to 84.0
|
83 percentage of alive at 10 years
Interval 80.0 to 85.0
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: Intention-to-treat
Disease-free survival (including locoregional and distant disease)
Outcome measures
| Measure |
Standard Breast Irradiation
n=916 Participants
radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
|
Breast Radiation Plus Regional Radiation
n=916 Participants
regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
|
|---|---|---|
|
Disease-free Survival
|
77 percentage of disease-free at 10 years
Interval 74.0 to 80.0
|
82 percentage of disease-free at 10 years
Interval 79.0 to 85.0
|
Adverse Events
Standard Breast Irradiation
Serious events: 1 serious events
Other events: 745 other events
Deaths: 0 deaths
Breast Radiation Plus Regional Radiation
Serious events: 3 serious events
Other events: 752 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Breast Irradiation
n=927 participants at risk
radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
Analysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment.
|
Breast Radiation Plus Regional Radiation
n=893 participants at risk
regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
Analysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
0.11%
1/927 • 10 years
|
0.34%
3/893 • 10 years
|
Other adverse events
| Measure |
Standard Breast Irradiation
n=927 participants at risk
radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
Analysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment.
|
Breast Radiation Plus Regional Radiation
n=893 participants at risk
regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
Analysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphedema
|
19.4%
180/927 • 10 years
|
25.3%
226/893 • 10 years
|
|
General disorders
Fatigue
|
38.1%
353/927 • 10 years
|
38.4%
343/893 • 10 years
|
|
General disorders
Pain due to radiation
|
27.2%
252/927 • 10 years
|
26.1%
233/893 • 10 years
|
|
General disorders
Joint
|
7.4%
69/927 • 10 years
|
10.0%
89/893 • 10 years
|
|
General disorders
Skin
|
33.8%
313/927 • 10 years
|
35.4%
316/893 • 10 years
|
|
General disorders
Subcutaneous tissue
|
18.0%
167/927 • 10 years
|
20.2%
180/893 • 10 years
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
13.6%
126/927 • 10 years
|
14.6%
130/893 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
14.1%
131/927 • 10 years
|
17.6%
157/893 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.3%
197/927 • 10 years
|
24.3%
217/893 • 10 years
|
|
Nervous system disorders
Neuropathy-sensory
|
20.2%
187/927 • 10 years
|
24.4%
218/893 • 10 years
|
|
Nervous system disorders
Neuropathic pain
|
11.9%
110/927 • 10 years
|
10.8%
96/893 • 10 years
|
|
Reproductive system and breast disorders
Gynecomastia
|
30.5%
283/927 • 10 years
|
28.7%
256/893 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
100/927 • 10 years
|
13.0%
116/893 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.7%
118/927 • 10 years
|
16.8%
150/893 • 10 years
|
|
Vascular disorders
Hot flashes/ flushes
|
7.0%
65/927 • 10 years
|
5.9%
53/893 • 10 years
|
Additional Information
Dr. Timothy J. Whelan
Juravinski Cancer Centre at Hamilton Health Sciences
Phone: 1(905) 387-9495
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place