Radiation Therapy (WBI Versus PBI) in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer.
PURPOSE: 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.
Radiation: 3-dimensional conformal accelerated partial breast irradiation
Radiation: whole breast irradiation
Radiation: MammoSite or other single-entry intracavitary device
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- In-breast tumor recurrence (IBTR) [ Time Frame: every 6 months for 5 years; annually thereafter for up to 10 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: time from randomization to death due to any cause assessed up to 15 years ] [ Designated as safety issue: No ]
- Recurrence-free survival [ Time Frame: time from randomization to recurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years ] [ Designated as safety issue: No ]
- Distant disease-free survival [ Time Frame: time from randomization to event occurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years ] [ Designated as safety issue: No ]
- Quality of life and patient-reported cosmesis by Breast Cancer Treatment Outcome Scale, MOS SF-36 Vitality, Convenience of Care scale, and symptoms [ Time Frame: measured at baseline, and 1 and 6 months and 1, 2, and 3 years after completion of study treatment ] [ Designated as safety issue: No ]
- Toxicity as assessed by adverse events during treatment [ Time Frame: at end of RT, and 4 weeks, 6 months, 12 months; every 6 months for years 2 through 5; and annually thereafter for up to 10 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||April 2020|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Group 1: WBI
Patients undergo whole breast irradiation (WBI) once daily, 5 days a week for 5-7 weeks.
Radiation: whole breast irradiation
Patients undergo radiation therapy once daily (days 1-5) for up to 7 weeks
Experimental: Group 2: PBI
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, MammoSite or other single-entry intracavitary device, or 3-dimensional conformal accelerated partial breast irradiation.
|Radiation: 3-dimensional conformal accelerated partial breast irradiation Radiation: brachytherapy Radiation: MammoSite or other single-entry intracavitary device|
- 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.)
- Group 1: Patients undergo whole-breast irradiation (WBI) once daily, 5 days a week, for 5-7 weeks.
- Group 2: Patients undergo partial-breast irradiation (PBI) twice daily on 5 days over a period of 5-10 days. This may be delivered by multi-catheter brachytherapy, single-entry 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. Note: Accrual closed on April 16, 2013, following approval of the Data Monitoring Committee to reduce the sample size from 4,300 to 4,214 patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103181
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|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|