This trial is active, not recruiting.

Condition early-stage breast cancer
Treatment tangential radiation
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator Brigham and Women's Hospital
Start date September 1998
End date January 2004
Trial size 100 participants
Trial identifier NCT00165243, 98-101


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.
time frame: 5 years

Secondary Outcomes

To determine the safety of this treatment.
time frame: 5 years

Eligibility Criteria

Male or female participants at least 55 years old.

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: - Prior history of malignancy, except for non-melanoma skin cancers and carcinoma in situ fo the cervix

Additional Information

Official title Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer
Principal investigator Julia S. Wong, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.