NCT00165243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
11.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

5.3 years

First QC Date

September 9, 2005

Last Update Submit

June 6, 2017

Conditions

Early-Stage Breast Cancer

Keywords

Axillary DissectionTangential RadiationBreast Cancer

Outcome Measures

Primary Outcomes (1)

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

    5 years

Secondary Outcomes (1)

  • To determine the safety of this treatment.

    5 years

Interventions

Tangential radiationPROCEDURE

Radiation given over 6 1/2 weeks

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Julia S. Wong, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

September 1, 1998

Primary Completion

January 1, 2004

Study Completion

December 1, 2016

Last Updated

June 7, 2017

Record last verified: 2017-06

Locations

US(2)