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| Sponsor: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Radiation Therapy Oncology Group Southwest Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00103181 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Radiation: 3-dimensional conformal accelerated partial breast irradiation Radiation: brachytherapy Radiation: whole breast irradiation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 |
| Estimated Enrollment: | 4300 |
| Study Start Date: | March 2005 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
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: 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.
|
Radiation: 3-dimensional conformal accelerated partial breast irradiation
Patients undergo radiation therapy twice daily (days 1-5) for up to 7 weeks
Radiation: brachytherapy
Patients undergo brachtherapy as PBI
|
OBJECTIVES:
Primary
Secondary
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.)
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ductal carcinoma in situ (DCIS*) or invasive* adenocarcinoma of the breast
Stage 0, I, or II disease
Gross disease must be unifocal
Prior axillary staging required for patients with invasive breast cancer, including 1 of the following:
No more than 3 positive axillary nodes
Must have undergone lumpectomy
No history of invasive breast cancer or DCIS
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
No prior breast implants
Other
Contacts and Locations
Show 361 Study Locations| Study Chair: | Frank Vicini, MD, FACR | William Beaumont Hospital - Royal Oak Campus |
| Investigator: | Douglas W. Arthur, MD | Massey Cancer Center |
| Investigator: | Robert R. Kuske, MD | University of Wisconsin, Madison |
| Study Chair: | Julia R. White, MD | Medical College of Wisconsin |
| Investigator: | Rachel A. Rabinovitch, MD | University of Colorado, Denver |
| Study Chair: | Lori J. Pierce, MD | University of Michigan Cancer Center |
More Information
| Responsible Party: | Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project |
| ClinicalTrials.gov Identifier: | NCT00103181 History of Changes |
| Other Study ID Numbers: | CDR0000409590, NSABP-B-39, RTOG-0413, SWOG-NSABP-B-39 |
| Study First Received: | February 7, 2005 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Unspecified |
|
stage II breast cancer ductal breast carcinoma in situ breast cancer in situ stage IA breast cancer stage IB breast cancer |
|
Breast Neoplasms Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary |