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A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women With Stage 0, I, or II Breast Cancer




A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women With Stage 0, I, or II Breast Cancer (USON RTOG 0413)

Study Description:

This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.

Inclusion Criteria:

» DISEASE CHARACTERISTICS:
» Histologically confirmed ductal carcinoma in situ (DCIS*) or invasive* adenocarcinoma of the breast - Stage 0, I, or II disease (Stage II tumors must be ≤ 3 cm); Gross disease must be unifocal (Microscopic multifocality allowed provided total pathological tumor size is ≤ 3 cm); No proven multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm; No non-epithelial breast malignancies (e.g., sarcoma or lymphoma) NOTE: *Patients who are 50 years of age and over with DCIS regardless of hormone receptor status AND patients with invasive breast cancer meeting all of the following criteria: ≥ 50 years of age, node-negative, and hormone-receptor positive status will not be enrolled in study after 12/30/2006
» Prior axillary staging required for patients with invasive breast cancer, including 1 of the following - Sentinel node biopsy alone (if sentinel node is negative); Sentinel node biopsy followed by axillary dissection or sampling with ≥ 6 axillary nodes (if sentinel node is positive); Axillary dissection alone with ≥ 6 axillary nodes
» No more than 3 positive axillary nodes - No axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension; No positive non-axillary sentinel nodes (intramammary nodes are staged as axillary nodes); No 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
» Must have undergone lumpectomy - Resected margins histologically free of tumor; Re-excision of surgical margins allowed; 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 suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign
» No Paget's disease of the nipple
» No history of invasive breast cancer or DCIS - Prior lobular carcinoma in situ treated by surgery alone allowed
» No synchronous bilateral invasive or non-invasive breast cancer
» Partial breast irradiation deemed technically deliverable by radiation oncologist at a credentialed facility
» Must have undergone a history and physical exam within the past 4 months AND a bilateral mammogram within the past 6 months
» Hormone receptor status - Estrogen receptor (ER) status known; Progesterone status known if ER analysis is negative; Marginal or borderline results are considered positive
» PATIENT CHARACTERISTICS:
» 18 and over
» Female
» Premenopausal or postmenopausal
» Life expectancy at least 10 years, excluding diagnosis of breast cancer
» Not pregnant or nursing
» Negative pregnancy test
» Fertile patients must use effective non-hormonal contraception
» No other malignancy within the past 5 years except previously treated carcinoma in situ of the cervix or colon, melanoma in situ, or basal cell or squamous cell skin cancer - Deemed to be at low risk for recurrence
» No collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma), specifically dermatomyositis with a CPK level above normal, or active skin rash
» No psychiatric or addictive disorder that would preclude study therapy
» PRIOR CONCURRENT THERAPY:
» No prior biologic therapy for this malignancy
» No prior chemotherapy for this malignancy
» No concurrent chemotherapy during study radiotherapy
» No prior hormonal therapy for this malignancy unless total duration of hormonal therapy was no more than 28 days before randomization
» 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
» No concurrent Femring^®
» No prior radiotherapy for this malignancy
» No prior breast or thoracic radiotherapy
» No concurrent brachytherapy boosts
» No concurrent intensity modulated radiotherapy
» No concurrent regional nodal irradiation
» No prior breast implants - Patients who have had implants removed are eligible
» No other concurrent anticancer therapy

Exclusion Criteria:


Location:


Texas Oncology - Baylor All Saints Medical Center at Fort Worth
1400 Eighth Avenue
Fort Worth , TX 76104

Lead Principal Investigator:

Stephen Sorgen, MD



For further information regarding this study, please contact the Office of Clinical Oncology Research Coordination at 214-818-8472 or via email at cancer.trials@baylorhealth.edu.

Last update: December 31, 2012
† Baylor Research Institute and Texas Oncology are not affiliated. Each reviews, approves, and conducts clinical trials independently. Their clinical trials are listed together on this website for the convenience of patients.