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Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed18 and overNCI, OtherCDR0000066410
P30CA023108, DMS-9801, DMS-12752, NCI-V98-1442, NCT00003404

Trial Description

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.

PURPOSE: This phase II trial is studying how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast.

Further Study Information

OBJECTIVES:

  • Determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy.
  • Determine the survival rate in patients treated with this regimen.

OUTLINE: Within 12 weeks after prior local excision or breast reexcision, patients undergo adjuvant radiotherapy 5 days a week for a total of 28 treatments.

Patients are followed every 6 months for 10 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within approximately 6-7 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:
  • Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia
  • Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia
  • Must have been excised with breast-conserving resection
  • No positive margins
  • Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision
  • No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the ipsilateral breast

Surgery

  • See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

National Cancer Institute

Richard J. BarthStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003404
ClinicalTrials.gov processed this data on January 15, 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.

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