Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	21 and over	NCI	SWOG-S9927 ACOSOG-S9927, CAN-NCIC-MA25, CLB-49910, E-S9927, NCCTG-S9927, NSABP-SWOG-S9927, RTOG-9915, GUMC-00223, NCT00005983, S9927

Objectives

1. 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.
2. Compare local regional control in patients treated with these regimens.
3. Assess the potential toxic effects of radiotherapy in this patient population.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Lori Pierce, MD, Protocol chair		Ph: 734-764-9922; 800-865-1125

North Central Cancer Treatment Group

Michael Haddock, MD, Protocol chair		Ph: 507-284-2511

American College of Surgeons Oncology Group

Stephen Edge, MD, Protocol chair		Ph: 716-845-2918; 800-685-6825

Eastern Cooperative Oncology Group

Eric Strom, MD, FACR, Protocol chair		Ph: 713-563-2300; 800-392-1611

Radiation Therapy Oncology Group

Lawrence Solin, MD, FACR, Protocol chair		Ph: 215-662-7267

Cancer and Leukemia Group B

Lawrence Marks, MD, Protocol chair(Contact information may not be current)		Ph: 919-660-2127 Email: marks@radonc.duke.edu

NCIC-Clinical Trials Group

Timothy Whelan, MD, Protocol chair		Ph: 905-387-9711 ext. 64509

National Surgical Adjuvant Breast and Bowel Project

Melvin Deutsch, MD, Protocol chair		Ph: 412-647-3600 Email: deutschm@upmc.edu

Registry Information
Official Title		Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women with One to Three Positive Axillary Nodes Phase III
Trial Start Date		2000-06-15
Registered in ClinicalTrials.gov		NCT00005983
Date Submitted to PDQ		2000-05-12
Information Last Verified		2003-09-24
NCI Grant/Contract Number		CA32102

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