Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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

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 - 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

Timothy J. Whelan, MD

David S. Parda

Julia R. White, MD

Lori J. Pierce, MD

Boon Chua, MD

Laura A. Vallow, MD

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.

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.

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

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

Disease-free survival (including locoregional and distant disease)

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

NCIC Clinical Trials Group

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.

Breast Radiation Plus Regional Radiation

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

Age, Continuous

Sex: Female, Male

Dr. Timothy J. Whelan

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.

Overall Survival

Disease-free Survival

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer	NCT00005957	Breast Cancer	Standard Breast... Breast Radiatio...	16 Years - 120 Years	Canadian Cancer Trials Group
Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer	NCT00005957	Breast Cancer	Standard Breast... Breast Radiatio...	16 Years - 120 Years	Canadian Cancer Trials Group

Spots Global Cancer Trial Database for standard breast irradiation