Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer

Early-Stage Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165243
• Other study ID #: 98-101
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: June 6, 2017
• Start date: September 1998
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-Stage Breast Cancer

Intervention

Procedure:
• Tangential radiation
Radiation given over 6 1/2 weeks

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.		5 years
Secondary	To determine the safety of this treatment.		5 years