Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Early-Stage Breast Cancer

Treatments

Procedure: Tangential radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT00165243

98-101

Details and patient eligibility

About

The purpose of this study is to evaluate whether treatment to the axilla (area under the arm) can be safely minimized by omitting axillary surgery and full axillary radiation therapy and replacing it with radiation therapy to the breast and lower axilla.

Full description

Patients will have undergone conservative breast surgery without axillary dissection prior to enrollment in this study.
Patients will receive radiation therapy to the breast, including the lowest axillary lymph nodes, over a period of 6 1/2 weeks.
No radiation will be specifically directed toward the upper axilla or supraclavicular lymph nodes.
Patients will also receive 5 years of tamoxifen or another type of hormone therapy determined by the medical oncologist.
Follow-up visits will occur every 6 months and mammograms every 12 months.

Enrollment

100 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must have clinical stage I or II breast cancer, clinically uninvolved axillary nodes.
Patients must be 55 years or older.
Patients must undergo total excision of the primary invasive tumor
Final pathologic margin status must be negative
Only estrogen receptor (ER) or progesterone receptor (PR) positive tumors will be permitted

Exclusion criteria