3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection

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.

OBJECTIVES:

* Determine the technical feasibility and reproducibility of three-dimensional conformal radiotherapy confined to the region of the lumpectomy cavity in women with stage I or II breast cancer.
* 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.

Eligibility 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 eligible:

    * 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