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

Phase 3
16 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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


- 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

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

Inclusion Criteria


- 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

- 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



- 16 and over


- Female

Menopausal status:

- Premenopausal or postmenopausal

Performance status:

- ECOG 0-2

Life expectancy:

- At least 5 years


- Not specified


- 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


- No serious nonmalignant renal disease


- No serious nonmalignant cardiovascular disease


- No serious nonmalignant pulmonary disease


- 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


Biologic therapy:

- Not specified


- See Disease Characteristics

- Concurrent standard adjuvant chemotherapy allowed

Endocrine therapy:

- See Disease Characteristics

- Concurrent standard adjuvant hormonal therapy allowed


- See Disease Characteristics


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

Duration of study

Outcome Time Frame:

13 years

Safety Issue:


Principal Investigator

Timothy J. Whelan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Margaret and Charles Juravinski Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

April 2000

Completion Date:

July 2014

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms