Radiation Therapy After Surgery, Chemotherapy, and/or Hormone Therapy in Treating Women With Stage II Breast Cancer

This study is ongoing, but not recruiting participants.

First Received: July 5, 2000 Last Updated: February 6, 2009 History of Changes

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group American College of Surgeons Eastern Cooperative Oncology Group Radiation Therapy Oncology Group Cancer and Leukemia Group B National Cancer Institute of Canada National Surgical Adjuvant Breast and Bowel Project (NSABP)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005983

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy, and/or hormone therapy with or without radiation therapy in treating women who have stage II breast cancer.

Condition	Intervention	Phase
Breast Cancer	Procedure: adjuvant therapy Radiation: radiation therapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy Radiation Therapy Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

June 2000

Detailed Description:

OBJECTIVES:

Compare overall and disease-free survival in women with stage II breast cancer with one to three positive nodes treated with radiotherapy vs observation only after mastectomy and adjuvant chemotherapy and/or hormonal therapy.
Compare local regional control in patients treated with these regimens.
Assess the potential toxic effects of radiotherapy in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior systemic hormonal therapy (chemotherapy with or without hormonal therapy vs hormonal therapy alone), prior taxane exposure (yes vs no), and duration of chemotherapy (no chemotherapy vs less than 3 months vs 3-5 months vs 6 months or more). Patients are randomized to one of two treatment arms.

Arm I: Patients undergo radiotherapy 5 days a week for 5 weeks.
Arm II: Patients are observed for disease progression. Patients are followed every 6 months for 2 years and then annually for 15 years.

PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per treatment arm) will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed stage II adenocarcinoma of the breast (T1-2, N1, M0)
- Primary tumor no greater than 5 cm
- At least 1 but no more than 3 positive axillary lymph nodes
- Nodes cannot be positive solely by cytokeratin staining
- No apocrine, adenocystic, or squamous cell carcinomas or sarcomas of the breast
- No bilateral breast cancer
- No active local regional disease
Must have undergone a modified radical mastectomy with a level I and II with or without a level III axillary dissection (at least 10 nodes examined) within the past 8 months
- Surgical margins negative for invasive and noninvasive ductal carcinoma
- No gross extracapsular disease or residual disease in the axilla
- Microscopic extracapsular extension allowed
No mastectomy after local failure following lumpectomy
Must have received adjuvant chemotherapy and/or hormonal therapy after mastectomy
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age:

21 and over

Sex:

Female

Menopausal status:

Pre- or post-menopausal

Performance status:

Zubrod 0-1

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No serious medical or psychiatric illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior trastuzumab (Herceptin)

Chemotherapy:

See Disease Characteristics
No more than 6 weeks since prior adjuvant chemotherapy
No other prior chemotherapy
Concurrent adjuvant chemotherapy allowed

Endocrine therapy:

See Disease Characteristics
Concurrent adjuvant hormonal therapy allowed

Radiotherapy:

No prior chest wall or nodal radiotherapy

Surgery:

See Disease Characteristics
Breast reconstruction allowed

Other:

Concurrent registration on another adjuvant chemotherapy or hormonal therapy study is allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005983

Locations

Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

North Central Cancer Treatment Group

American College of Surgeons

Eastern Cooperative Oncology Group

Radiation Therapy Oncology Group

Cancer and Leukemia Group B

National Cancer Institute of Canada

National Surgical Adjuvant Breast and Bowel Project (NSABP)

Investigators

Study Chair:	Lori J. Pierce, MD	University of Michigan Cancer Center
Study Chair:	Michael G. Haddock, MD	Mayo Clinic
Study Chair:	Stephen B. Edge, MD	Roswell Park Cancer Institute
Study Chair:	Eric A. Strom, MD, FACR	M.D. Anderson Cancer Center
Study Chair:	Lawrence J. Solin, MD, FACR	University of Pennsylvania
Study Chair:	Lawrence B. Marks, MD	Duke University
Study Chair:	Timothy J. Whelan, MD	Margaret and Charles Juravinski Cancer Centre
Study Chair:	Melvin Deutsch, MD	UPMC Cancer Center at UPMC Presbyterian

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067971, SWOG-S9927, ACOSOG-S9927, CAN-NCIC-MA25, CLB-49910, E-S9927, NCCTG-S9927, NSABP-SWOG-S9927, RTOG-9915, GUMC-00223
Study First Received:	July 5, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00005983 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II breast cancer

Study placed in the following topic categories:

Skin Diseases
Adjuvants, Immunologic
Breast Neoplasms
Hormones
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009