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

NCT00005957 | Completed Results DMC

• 8 other identifiers: MA20CAN-NCIC-MA20NSABP-CAN-NCIC-MA20NCCTG-CAN-NCIC-MA20RTOG-CAN-NCIC-MA20SWOG-CAN-NCIC-MA20TROG-CAN-NCIC-MA20CDR0000067938
• Study Type: interventional
• Target: 1,832
• Locations: 1 country
• Sites: 26

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Duration of study

  10 years

Secondary Outcomes (1)

• Disease-free Survival

  10 years

Study Arms (2)

Standard Breast Irradiation

ACTIVE COMPARATOR

Radiation: Standard Breast Irradiation

Breast Radiation plus regional radiation

EXPERIMENTAL

regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)

Radiation: Breast Radiation plus Regional Radiation

Interventions

Standard Breast Irradiation RADIATION

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.

Standard Breast Irradiation

Breast Radiation plus Regional Radiation RADIATION

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.

Breast Radiation plus regional radiation

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven invasive carcinoma of the breast * No evidence of T4, N2-3, or M1 disease prior to surgery * Node positive or high-risk node negative * Prior breast-conserving therapy (BCT) (e.g., lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy required and must be a candidate for breast radiotherapy after BCT * Normally patients should have microscopically clear resection margins and those with positive margins should undergo reexcision * Patients with microscopically focally positive margins (defined as no greater than 3 times high power fields) are candidates for breast radiotherapy plus a boost to the lumpectomy site * Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria * If node positive, then a level I and II axillary dissection must be performed * No evidence of residual disease in axilla after dissection * Must be treated with currently accepted adjuvant systemic chemotherapy and/or hormonal therapy * High risk of regional and systemic recurrence due to one of the following: * Pathologically positive axillary lymph nodes * Pathologically negative axillary lymph nodes with one of the following: * Primary tumor greater than 5 cm * Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following: * Estrogen receptor negative * Skarf-Bloom-Richardson grade 3 * Lymphovascular invasion * Hormone receptor status: * Estrogen and progesterone receptor status known PATIENT CHARACTERISTICS: Age: * 16 and over Sex: * Female Menopausal status: * Premenopausal or postmenopausal Performance status: * ECOG 0-2 Life expectancy: * At least 5 years Hematopoietic: * Not specified Hepatic: * SGOT and/or SGPT no greater than 3 times upper limit of normal (ULN)\* * Alkaline phosphatase no greater than 3 times ULN\* NOTE: \* Patients with laboratory values greater than 3 times ULN may still be eligible if no metastatic disease by imaging examinations Renal: * No serious nonmalignant renal disease Cardiovascular: * No serious nonmalignant cardiovascular disease Pulmonary: * No serious nonmalignant pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other serious nonmalignant disease (e.g., systemic lupus erythematosus or scleroderma) that would preclude definitive surgery or radiotherapy * No other malignancy except: * Nonmelanomatous skin cancer * Carcinoma in situ of the cervix or endometrium * Contralateral noninvasive breast cancer (unless prior radiotherapy to the contralateral breast) * Invasive carcinoma of the cervix, endometrium, colon, thyroid, or melanoma that was curatively treated at least 5 years prior to study participation * No psychiatric or addictive disorder that would preclude informed consent or study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * Concurrent standard adjuvant chemotherapy allowed Endocrine therapy: * See Disease Characteristics * Concurrent standard adjuvant hormonal therapy allowed Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• National Cancer Institute (NCI): collaborator
• NSABP Foundation Inc: collaborator
• Radiation Therapy Oncology Group: collaborator
• SWOG Cancer Research Network: collaborator
• Trans Tasman Radiation Oncology Group: collaborator
• North Central Cancer Treatment Group: collaborator

Study Sites (26)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BCCA - Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

The Vitalite Health Network - Dr. Leon Richard

Moncton, New Brunswick, E1C 8X3, Canada

Location

Atlantic Health Sciences Corporation

Saint John, New Brunswick, E2L 4L2, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, AIB 3V6, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Northeast Cancer Center Health Sciences

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Niagara Health System

St. Catharines, Ontario, L2R 7C6, Canada

Location

Thunder Bay Regional Health Science Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

CHA-Hopital Du St-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (2)

• 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.

  PMID: 26200977 RESULT

• Gross JP, Whelan TJ, Parulekar WR, Chen BE, Rademaker AW, Helenowski IB, Donnelly ED, Strauss JB. Development and Validation of a Nomogram to Predict Lymphedema After Axillary Surgery and Radiation Therapy in Women With Breast Cancer From the NCIC CTG MA.20 Randomized Trial. Int J Radiat Oncol Biol Phys. 2019 Sep 1;105(1):165-173. doi: 10.1016/j.ijrobp.2019.05.002. Epub 2019 May 11.

  PMID: 31085285 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Timothy J. Whelan
• Organization: Juravinski Cancer Centre at Hamilton Health Sciences

twhelan@HHSC.CA

1(905) 387-9495

Study Officials

• Timothy J. Whelan, MD

  Margaret and Charles Juravinski Cancer Centre

  STUDY CHAIR

• David S. Parda

  Allegheny Cancer Center at Allegheny General Hospital

  STUDY CHAIR

• Julia R. White, MD

  Medical College of Wisconsin

  STUDY CHAIR

• Lori J. Pierce, MD

  University of Michigan Rogel Cancer Center

  STUDY CHAIR

• Boon Chua, MD

  Peter MacCallum Cancer Centre, Australia

  STUDY CHAIR

• Laura A. Vallow, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: March 9, 2000
• Primary Completion: November 20, 2014
• Study Completion: April 19, 2017
• Last Updated: August 21, 2023
• Results First Posted: June 15, 2016

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (26)