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Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedTreatmentClosed18 and overNCI, OtherCASE2104
P30CA043703, NCT00527293

Trial Description

Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.

Further Study Information

OBJECTIVES:

  • To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques.
  • To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire.
  • To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique.
  • To evaluate wound healing and overall complication rate after partial breast irradiation.
  • To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.

OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days.

After completion of study therapy, patients are followed periodically for up to 5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer, including the following histologic subtypes:
  • Invasive ductal carcinoma
  • Medullary ductal carcinoma
  • Papillary ductal carcinoma
  • Colloid (mucinous) ductal carcinoma
  • Tubular ductal carcinoma
  • The following histologic subtypes are not allowed:
  • Invasive lobular carcinoma
  • Extensive lobular carcinoma in situ
  • Ductal carcinoma in situ (DCIS)
  • Nonepithelial breast malignancies, such as lymphoma or sarcoma
  • No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue)
  • Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)
  • Lesion ≤ 3 cm
  • No more than 3 positive lymph nodes
  • Patients with 4 or more positive axillary lymph nodes found at the time of axillary lymph node dissection/sentinel lymph node biopsy are not eligible
  • Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy)
  • Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR a negative re-excision margin
  • Unifocal breast cancer
  • No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm)
  • No palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative
  • No skin involvement of disease
  • No Paget's disease of the nipple
  • No distant metastatic disease
  • Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • Not pregnant or lactating
  • Negative pregnancy test
  • Fertile patients must use effective contraception for ≥ 1 week prior to, during, and for ≥ 2 weeks after completion of study treatment
  • No collagen vascular disorders, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
  • No psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent
  • No other malignancy within the past 5 years, except non-melanomatous skin cancer

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy to the breast
  • No chemotherapy for at least 2 weeks before and 2 weeks after completion of study radiotherapy
  • Concurrent hormonal therapy allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

Case Comprehensive Cancer Center

National Cancer Institute

Janice Lyons, MDStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00527293
ClinicalTrials.gov processed this data on December 19, 2013

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.

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