Whole Breast Irradiation vs Twice Daily vs. Once Daily Accelerated Partial Breast Irradiation

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Accelerated partial Breast Irradiation, Breast cosmesis, radiation Toxicity Read More

Inclusion Criteria:

Tumor characteristics

• Histologically confirmed invasive adenocarcinoma of the breast
• Tumors must be ≤ 3 cm. Gross disease must be unifocal. Negative lymph nodes
• Hormone receptor status:

Estrogen receptor (ER) status known Progesterone status known if ER analysis is negative Marginal or borderline results are considered positive Surgery

• Tumor removed with conservative breast surgery with adequate margin
• Re-excision of surgical margins allowed
• No prior breast implants

• Prior axillary staging required for patients including 1 of the following:

  • Sentinel node biopsy alone (if sentinel node is negative)
  • Sentinel node biopsy followed by axillary dissection if sentinel node is positive)
  • Axillary dissection alone with ≥ 6 axillary nodes
• Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume ≤ 30% based on postoperative pre-randomization CT scan
• Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days
• No prior biologic therapy for this malignancy Chemotherapy
• No prior chemotherapy for this malignancy
• No concurrent chemotherapy during study radiotherapy Endocrine therapy
• No prior hormonal therapy for this malignancy
• Concurrent hormonal therapy allowed provided it is not administered during chemotherapy
• No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulating drugs
• No concurrent hormone replacement therapy Radiotherapy
• No prior radiotherapy for this malignancy
• No prior breast or thoracic radiotherapy
• No concurrent regional nodal irradiation Other
• No other concurrent anticancer therapy Menopausal status
• Premenopausal or postmenopausal Performance status
• WHO 0-1 Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective non-hormonal contraception

Exclusion Criteria:

• Multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm.
• Non-epithelial breast malignancies (e.g., sarcoma or lymphoma).
• Positive axillary nodes.
• Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor.
• Suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign
• Paget's disease of the nipple
• Previous history of invasive breast cancer or DCIS.
• Synchronous bilateral invasive or non-invasive breast cancer
• Collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma), specifically dermatomyositis with a CPK level above normal, or active skin rash
• Psychiatric or addictive disorder that would preclude study therapy