A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I and II Breast Carcinoma
Inclusion 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