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

Alternate Title

Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	26 and over	NCI	RTOG-9804 CAN-NCIC-MA26, CALGB-49801, RTOG-DEV-1026, RTOG-98-04, NCT00003857, MA26

Special Category: CTSU trial

Objectives

1. Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast.
2. Compare distant disease-free survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis
  • Unicentric
  • Lesions ≤ 2.5 cm
  • Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in < one third of the involved ducts
  • Inked margins ≥ 3 mm
  • Clinically node negative
  • Non-palpable



• No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery



• No bloody nipple discharge



• No more than 12 weeks since prior final surgery (arm II only)



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills)

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• 26 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant or nursing
• No active connective tissue disorders (e.g., lupus or scleroderma)
• No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

Expected Enrollment

A total of 1,790 patients will be accrued for this study within 6 years.

Outcomes

Local recurrence (e.g., invasive or noninvasive recurrence)

Overall survival
Time to distant metastasis
Invasive local recurrence
Salvage mastectomy rate

Outline

This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years.



• Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Beryl McCormick, MD, Protocol chair		Ph: 212-639-6828; 800-525-2225
Clifford Hudis, MD, Protocol co-chair		Ph: 646-888-4551; 800-525-2225

Cancer and Leukemia Group B

Barbara Smith, MD, PhD, Protocol chair		Ph: 617-724-1074; 877-726-5130 Email: blsmith1@partners.org

NCIC-Clinical Trials Group

Timothy Whelan, MD, Protocol chair		Ph: 905-387-9711 ext. 64509
Eileen Rakovitch, MD, Protocol co-chair		Ph: 416-480-4806 Email: eileen.rakovitch@sunnybrook.ca

Registry Information
Official Title		Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus RT for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast
Trial Start Date		1999-12-13
Trial Completion Date		2004-02-24 (estimated)
Registered in ClinicalTrials.gov		NCT00003857
Date Submitted to PDQ		1999-04-07
Information Last Verified		2006-07-13
NCI Grant/Contract Number		CA21661