Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer

Phase 2

Completed

• Conditions: Early-Stage Breast Cancer

• Registration Number: NCT00165243
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1998-09
• Primary Completion: 2004-01
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Study Completion: 2016-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.	5 years

Secondary Outcome Measures

Name	Time	Method
To determine the safety of this treatment.	5 years

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States