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Breast CancerNCT00005957

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

A study testing Standard Breast Irradiation and Breast Radiation plus Regional Radiation in people with Breast Cancer, run by NCIC Clinical Trials Group at 26 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 120 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Standard Breast Irradiation and Breast Radiation plus Regional Radiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,832 participants
Where
26 sitesCanada
Study dates
9 Mar 2000to 19 Apr 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 120 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Canada26 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Northeast Cancer Center Health Sciences

    Greater Sudbury, Ontario, P3E 5J1

  • QEII Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • The Vitalite Health Network - Dr. Leon Richard

    Moncton, New Brunswick, E1C 8X3

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • McGill University - Dept. Oncology

    Montreal, Quebec, H2W 1S6

  • Ottawa Health Research Institute - General Division

    Ottawa, Ontario, K1H 8L6

  • CHUQ-Pavillon Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • CHA-Hopital Du St-Sacrement

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Atlantic Health Sciences Corporation

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Niagara Health System

    St. Catharines, Ontario, L2R 7C6

  • Dr. H. Bliss Murphy Cancer Centre

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

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • BCCA - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Phase III Study of Regional Radiation Therapy in Early Breast Cancer

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.

Read the detailed description

OBJECTIVES:

  • Compare the overall survival, disease-free survival, isolated local regional disease-free survival, and distant disease-free survival in women with previously resected, early stage, invasive breast cancer treated with breast radiotherapy with or without regional radiotherapy.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the quality of life of patients (in certain participating centers) treated with these regimens.
  • Compare the cosmetic outcomes in patients (in certain participating centers) treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs more than 3), number of axillary nodes removed (<10, > or equal to 10); type of chemotherapy (anthracycline containing vs other vs none), hormonal therapy (yes vs no), number of axillary lymph nodes excised*, and participating center. Patients are randomized to one of two treatment arms.

NOTE: * Patients with a negative sentinel node dissection with or without an axillary dissection will be stratified according to the total number of nodes removed

  • Arm I: Patients undergo standard breast radiotherapy alone 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo breast and regional radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.

Radiotherapy in both arms begins as soon as possible after randomization. Radiotherapy must begin within 8 weeks after completion of adjuvant IV chemotherapy, unless radiotherapy is administered concurrently with chemotherapy (i.e., cyclophosphamide, methotrexate, and fluorouracil [CMF]), or within 16 weeks after the last breast surgery for patients treated with hormonal therapy alone.

Quality of life is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 and 9 months after completion of radiotherapy, and then annually until first distant disease recurrence.

Cosmetic outcome is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, and then at 3 and 5 years after completion of radiotherapy or until first distant disease recurrence.

Patients are followed at 3, 6, and 9 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 1,822 patients will be accrued for this study within approximately 4 years.

Conditions
Breast Cancer
Being tested
Standard Breast Irradiation, Breast Radiation plus Regional Radiation
Keywords
stage I breast cancer, stage II breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Breast IrradiationRadiation

    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 RadiationRadiation

    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.

Study groups in NCT00005957
Study groupRoleWhat they receive
Standard Breast IrradiationActive comparatorNot described
Receives: Radiation: Standard Breast Irradiation
Breast Radiation plus regional radiationExperimentalregional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Receives: Radiation: Breast Radiation plus Regional Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Duration of study

    Measured: 10 years

Secondary outcomes (1)

  1. Disease-free Survival

    Disease-free survival (including locoregional and distant disease)

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start9 Mar 2000
  3. Primary completion20 Nov 2014
  4. Study completion19 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,832 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005957
Sponsor's protocol ID
MA20
Other IDs
CAN-NCIC-MA20, NSABP-CAN-NCIC-MA20, NCCTG-CAN-NCIC-MA20, RTOG-CAN-NCIC-MA20, SWOG-CAN-NCIC-MA20, TROG-CAN-NCIC-MA20, CDR0000067938
Status last verified
Mar 2020
First submitted
5 Jul 2000
Last updated
21 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26200977

  • 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.

    PubMed 31085285

Questions about this trial

What is this clinical trial studying?

A study testing Standard Breast Irradiation and Breast Radiation plus Regional Radiation in people with Breast Cancer, run by NCIC Clinical Trials Group at 26 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005957, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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