Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer

June 6, 2017 updated by: Julia S. Wong, MD, Dana-Farber Cancer Institute

Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Early-Stage Breast Cancer

Intervention / Treatment

Procedure: Tangential radiation

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02115
    - Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation. Time Frame: 5 years	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the safety of this treatment. Time Frame: 5 years	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital

Brigham and Women's Hospital

Investigators

Principal Investigator: Julia S. Wong, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria