Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00165243

Enrollment

100

Registered

2005-09-14

Start date

1998-09-30

Completion date

2016-12-31

Last updated

2017-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-Stage Breast Cancer

Keywords

Axillary Dissection, Tangential Radiation, Breast Cancer

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.

Interventions

PROCEDURETangential radiation

Radiation given over 6 1/2 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To determine the safety of this treatment.	5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026