- Compare local tumor control in women with ductal carcinoma in situ or stage I or II breast cancer treated with adjuvant whole breast vs partial breast irradiation following lumpectomy.
- Compare overall survival, recurrence-free survival, and distant disease-free survival in patients treated with these regimens.
- Compare the cosmetic result in patients treated with these regimens.
- Compare fatigue and treatment-related symptoms in patients treated with these regimens.
- Compare perceived convenience of care in patients treated with these regimens.
- Compare acute and late toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (ductal carcinoma in situ [DCIS] only vs invasive and node negative vs invasive with 1-3 positive nodes), menopausal status (premenopausal vs postmenopausal), hormone receptor status (estrogen receptor [ER]-positive and/or progesterone receptor [PR]-positive vs ER-negative and PR-negative), intention to receive chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. (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.)
- Arm I: Patients undergo whole-breast irradiation (WBI) once daily, 5 days a week, for 5-7 weeks.
- Arm II: Patients undergo partial-breast irradiation (PBI) twice daily on 5 days over a period of 5-10 days. This may be delivered by intracavitary brachytherapy or 3-D conformal radiotherapy.
Patients in both arms may receive adjuvant chemotherapy at least 2 weeks prior to initiation of WBI OR at least 2 weeks after completion of PBI at the discretion of the treating physician. Patients with ER-positive or PR-positive tumors may also receive hormonal therapy, beginning 3-12 weeks after completion of adjuvant chemotherapy (or before, during, or after completion of WBI or PBI for patients not receiving adjuvant chemotherapy) and continuing for at least 5 years.
After completion of study treatment, patients are followed at 1 and 6 months, every 6 months for 4.5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 4,300 patients (2,150 per treatment arm) will be accrued for this study within 4.6 years.
- 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
- 18 and over
- Premenopausal or postmenopausal
- Not specified
- At least 10 years, excluding diagnosis of breast cancer
- Not specified
- Not specified
- Not specified
- 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
- See Disease Characteristics
- No prior breast implants
- Patients who have had implants removed are eligible
- No other concurrent anticancer therapy
Last updated: 10/07/2012