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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overNCI, OtherNSABP B-39/RTOG 0413
NSABP-B-39, RTOG-0413, SWOG-NSABP-B-39, NCI-2009-00698, NCT00103181

Trial Description

Summary

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.

Further Study Information

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Eligibility 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:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Premenopausal or postmenopausal

Performance status

  • Not specified

Life expectancy

  • At least 10 years, excluding diagnosis of breast cancer

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • 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 creatine phosphokinase (CPK) level above normal, or active skin rash
  • No psychiatric or addictive disorder that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for this malignancy

Chemotherapy

  • No prior chemotherapy for this malignancy
  • No concurrent chemotherapy during study radiotherapy

Endocrine therapy

  • 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^®

Radiotherapy

  • 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

Surgery

  • See Disease Characteristics
  • No prior breast implants
  • Patients who have had implants removed are eligible

Other

  • No other concurrent anticancer therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

National Surgical Adjuvant Breast and Bowel Project

National Cancer Institute

Radiation Therapy Oncology Group

Southwest Oncology Group

Norman WolmarkPrincipal Investigator

Trial Sites

U.S.A.
California
  Stanford
 Stanford Cancer Center
 Irene L. Wapnir Ph: 650-498-7061
  Email: clinicaltrials@med.stanford.edu
Connecticut
  Torrington
 Connecticut Oncology & Hematology - Torrington
 Michael C. Magnifico Ph: 860-482-5384
Florida
  Daytona Beach
 Herbert D. Kerman Regional Oncology Center - Daytona Beach
 Ruby Anne E Deveras Ph: 386-254-4211
Illinois
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
  Indianapolis
 Community Regional Cancer Care at Community Hospital East
 Shih J Wei Ph: 800-777-7775
 St. Vincent Indianapolis Hospital
 Ruemu E Birhiray Ph: 317-338-2194
Michigan
  Flint
 Genesys Hurley Cancer Institute
 Samir Narayan Ph: 734-712-3456
New Jersey
  Long Branch
 Monmouth Medical Center
 Mitchell F Weiss Ph: 732-923-7689
  Somerville
 Somerset Medical Center
 Laura R Bond Ph: 908-685-2481
Ohio
  Lima
 St. Rita's Medical Center
 Henry Gerad Ph: 419-226-9617
Pennsylvania
  Pittsburgh
 National Surgical Adjuvant Breast and Bowel Project
 Frank Vicini Ph: 248-551-7695
  Email: fvicini@beaumont.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00103181
ClinicalTrials.gov processed this data on March 16, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.