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Completed

NCT Number: NCT00165243

Tangential Radiation Therapy Without Axillary Dissection in 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.

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Key information

Conditions

Early-Stage Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tangential radiation

Procedure

Radiation given over 6 1/2 weeks

Primary outcomes

  1. To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.

    Time frame: 5 years

Secondary outcomes

  1. To determine the safety of this treatment.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Brigham and Women's Hospital
  • Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2004
Study completion
2016
First posted
Sep 14, 2005
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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