RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation therapy in treating women who have undergone lumpectomy and axillary node dissection for stage I or stage II breast cancer.

Condition	Treatment or Intervention	Phase
stage I breast cancer stage II breast cancer	Procedure: radiation therapy	Phase I Phase II

OBJECTIVES:

• Determine the technical feasibility and reproducibility of three-dimensional conformal radiotherapy in women with stage I or II breast cancer previously treated with lumpectomy and axillary node dissection.
• Determine the cosmetic results in patients treated with this regimen.
• Determine the complication rates in patients treated with this regimen.
• Determine the local control rate in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning within 8 weeks after surgery.

Patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-46 patients will be accrued for this study within 6.3 to 15.3 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer
• Stage I or II (T1, N0; T1, N1; T2, N0; or T2, N1)
• Unifocal disease (single focus that can be encompassed by one lumpectomy)
• The following histologies are eligilble:
• Invasive ductal
• Medullary
• Papillary
• Colloid (mucinous)
• Tubular
• No invasive or extensive in situ lobular carcinoma or pure ductal carcinoma in situ (DCIS)
• No nonepithelial breast malignancies such as sarcoma or lymphoma
• Previously treated with lumpectomy of a lesion no greater than 3 cm and axillary dissection of at least 6 lymph nodes or a sentinel node biopsy
• Six surgical clips in place delineating the margins of the tylectomy cavity
• Negative, inked histologic margins of lumpectomy (greater than 2 mm) OR re-excision specimen available for confirmation
• Negative mammography post-lumpectomy or post-excision if malignancy-associated microcalcifications were initially present
• No prior lumpectomy so extensive that the cosmetic result is low or poor prior to radiotherapy
• No more than 3 positive axillary nodes
• No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless negative by biopsy
• No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless nodes are histologically negative
• No extensive intraductal carcinoma, indicated by one of the following according to the Harvard definition:
• More than 25 % of invasive tumor is DCIS and DCIS is in adjacent breast tissue
• Intraductal carcinoma with microinvasion
• No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
• No evidence of suspicious microcalcifications
• No Paget's disease of the nipple
• No skin involvement by disease, regardless of tumor size
• No distant metastases
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• At least 2 years

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Technically suitable for breast radiotherapy
• No collagenous diseases (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis)
• No other medical condition that would limit life expectancy
• No psychiatric or addictive disorders that would preclude giving informed consent
• No other malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• At least 2 weeks since prior chemotherapy
• No concurrent chemotherapy during and for at least 2 weeks after completion of study therapy

Endocrine therapy

• Concurrent anastrozole or tamoxifen allowed

Radiotherapy

• No prior radiotherapy for the current malignancy

Surgery

• See Disease Characteristics

Other

• No prior nonhormonal therapy for the current malignancy

Arizona
      Foundation for Cancer Research and Education, Phoenix,  Arizona,  85013,  United States; Recruiting
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting

Study chairs or principal investigators

Frank Vicini, MD,  Study Chair,  William Beaumont Hospital - Royal Oak   

Study ID Numbers:  CDR0000316246; RTOG-0319
Record last reviewed:  May 2004
Record first received:  September 10, 2003
ClinicalTrials.gov Identifier:  NCT00068263
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-16