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Status:

COMPLETED

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

Lead Sponsor:

NSABP Foundation Inc

Collaborating Sponsors:

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief 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 who...

Detailed Description

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 lum...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2018

    Estimated Enrollment :

    4216 Patients enrolled

    Trial Details

    Trial ID

    NCT00103181

    Start Date

    March 1 2005

    End Date

    August 1 2018

    Last Update

    April 14 2022

    Active Locations (387)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 97 (387 locations)

    1

    UAB Comprehensive Cancer Center

    Birmingham, Alabama, United States, 35294

    2

    Arizona Center for Cancer Care - Peoria

    Peoria, Arizona, United States, 85381

    3

    Arizona Oncology Services Foundation

    Phoenix, Arizona, United States, 85013

    4

    Arizona Breast Cancer Specialists

    Scottsdale, Arizona, United States, 85258