Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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Early-Stage Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tangential radiation

Radiation given over 6 1/2 weeks

Intervention Type PROCEDURE

Eligibility Criteria

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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