Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Temporarily closed	18 and over	Other	DMS-9801 DMS-12752, NCI-V98-1442, NCT00003404

Objectives

1. 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.
2. Determine the survival rate in patients treated with this regimen.

Entry 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

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

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

Expected Enrollment

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

Outcomes

Local recurrence rate

Survival rate

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.

Barth RJ Jr, Wells WA, Mitchell SE, et al.: A prospective, multi-institutional study of adjuvant radiotherapy after resection of malignant phyllodes tumors. Ann Surg Oncol 16 (8): 2288-94, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Richard Barth, MD, Protocol chair		Ph: 603-650-7903; 800-639-6918 Email: richard.j.barth.jr@dartmouth.edu

Registry Information
Official Title		A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors
Trial Start Date		1998-01-15
Registered in ClinicalTrials.gov		NCT00003404
Date Submitted to PDQ		1998-06-29
Information Last Verified		2009-07-05
NCI Grant/Contract Number		P30-CA23108

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