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Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer

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: NCT00005957
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : June 15, 2016
Last Update Posted : August 21, 2023
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NSABP Foundation Inc
Radiation Therapy Oncology Group
SWOG Cancer Research Network
Trans Tasman Radiation Oncology Group
North Central Cancer Treatment Group
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Radiation: Standard Breast Irradiation
Radiation: Breast Radiation plus Regional Radiation
Enrollment 1832
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Breast Irradiation Breast Radiation Plus Regional Radiation
Hide Arm/Group Description 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.

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.
Period Title: Overall Study
Started 916 916
Completed 908 888
Not Completed 8 28
Reason Not Completed
No treated             3             9
Crossover to the other arm             5             19
Arm/Group Title Standard Breast Irradiation Breast Radiation Plus Regional Radiation Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 916 916 1832
Hide Baseline Analysis Population Description
Intention-to-treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 916 participants 916 participants 1832 participants
54  (10) 54  (10) 54  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 916 participants 916 participants 1832 participants
Female
916
 100.0%
916
 100.0%
1832
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Overall Survival
Hide Description Duration of study
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Standard Breast Irradiation Breast Radiation Plus Regional Radiation
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 916 916
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of alive at 10 years
82
(79 to 84)
83
(80 to 85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Breast Irradiation, Breast Radiation Plus Regional Radiation
Comments It was estimated that the actuarial five year survival of patients on the control arm of this trial would be 80% and a 5% increase in five year survival with experiment arm is clinically interesting to detect. A sample size of 1832 will ensure 80% power to detect such a difference with two-sided alpha of 0.05.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.72 to 1.13
Estimation Comments Hazard ratio (HR) estimation is for Standard Breast Irradiation arm versus Breast Radiation plus regional radiation arm.
2.Secondary Outcome
Title Disease-free Survival
Hide Description Disease-free survival (including locoregional and distant disease)
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Standard Breast Irradiation Breast Radiation Plus Regional Radiation
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 916 916
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of disease-free at 10 years
77
(74 to 80)
82
(79 to 85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Breast Irradiation, Breast Radiation Plus Regional Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.61 to 0.94
Estimation Comments [Not Specified]
Time Frame 10 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Breast Irradiation Breast Radiation Plus Regional Radiation
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Standard Breast Irradiation Breast Radiation Plus Regional Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Standard Breast Irradiation Breast Radiation Plus Regional Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   1/927 (0.11%)   3/893 (0.34%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Secondary Malignancy † 1  1/927 (0.11%)  3/893 (0.34%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Breast Irradiation Breast Radiation Plus Regional Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   745/927 (80.37%)   752/893 (84.21%) 
Blood and lymphatic system disorders     
Lymphedema † 1  180/927 (19.42%)  226/893 (25.31%) 
General disorders     
Fatigue † 1  353/927 (38.08%)  343/893 (38.41%) 
Pain due to radiation † 1  252/927 (27.18%)  233/893 (26.09%) 
Joint † 1  69/927 (7.44%)  89/893 (9.97%) 
Skin † 1  313/927 (33.76%)  316/893 (35.39%) 
Subcutaneous tissue † 1  167/927 (18.02%)  180/893 (20.16%) 
Injury, poisoning and procedural complications     
Radiation dermatitis † 1  126/927 (13.59%)  130/893 (14.56%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness † 1  131/927 (14.13%)  157/893 (17.58%) 
Myalgia † 1  197/927 (21.25%)  217/893 (24.30%) 
Nervous system disorders     
Neuropathy-sensory † 1  187/927 (20.17%)  218/893 (24.41%) 
Neuropathic pain † 1  110/927 (11.87%)  96/893 (10.75%) 
Reproductive system and breast disorders     
Gynecomastia † 1  283/927 (30.53%)  256/893 (28.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  100/927 (10.79%)  116/893 (12.99%) 
Dyspnea † 1  118/927 (12.73%)  150/893 (16.80%) 
Vascular disorders     
Hot flashes/ flushes † 1  65/927 (7.01%)  53/893 (5.94%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Timothy J. Whelan
Organization: Juravinski Cancer Centre at Hamilton Health Sciences
Phone: 1(905) 387-9495
EMail: twhelan@HHSC.CA
Publications of Results:
Whelan TJ, Olivotto IA, Parulekar WR, Ackerman I, Chua BH, Nabid A, Vallis KA, White JR, Rousseau P, Fortin A, Pierce LJ, Manchul L, Chafe S, Nolan MC, Craighead P, Bowen J, McCready DR, Pritchard KI, Gelmon K, Murray Y, Chapman JA, Chen BE, Levine MN; MA.20 Study Investigators. Regional Nodal Irradiation in Early-Stage Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):307-16. doi: 10.1056/NEJMoa1415340.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Canadian Cancer Trials Group ( NCIC Clinical Trials Group )
ClinicalTrials.gov Identifier: NCT00005957    
Other Study ID Numbers: MA20
CAN-NCIC-MA20
NSABP-CAN-NCIC-MA20 ( Other Identifier: NSABP )
NCCTG-CAN-NCIC-MA20 ( Other Identifier: NCCTG )
RTOG-CAN-NCIC-MA20 ( Other Identifier: RTOG )
SWOG-CAN-NCIC-MA20 ( Other Identifier: SWOG )
TROG-CAN-NCIC-MA20 ( Other Identifier: TROG )
CDR0000067938 ( Other Identifier: PDQ )
First Submitted: July 5, 2000
First Posted: January 27, 2003
Results First Submitted: April 5, 2016
Results First Posted: June 15, 2016
Last Update Posted: August 21, 2023