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
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|ClinicalTrials.gov Identifier: NCT00103181|
Recruitment Status : Unknown
Verified December 2018 by NSABP Foundation Inc.
Recruitment status was: Active, not recruiting
First Posted : February 8, 2005
Last Update Posted : January 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: 3-dimensional conformal accelerated partial breast irradiation Radiation: brachytherapy Radiation: whole breast irradiation Radiation: MammoSite or other single-entry intracavitary device||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2019|
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: MammoSite or other single-entry intracavitary device
- In-breast tumor recurrence (IBTR) [ Time Frame: every 6 months for 5 years; annually thereafter for up to 10 years ]
- Overall survival [ Time Frame: time from randomization to death due to any cause assessed up to 15 years ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103181
|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|