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Hypofractionated Radiation for Breast Cancer

N/A
Recruiting
Led By Joshua Dilworth, MD
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG (Zubrod) performance status 0-1
Clinical N stage of cN0, cN1, or cN2a
Must not have
Clinical N stage of cN2b, cN3 disease, pathologic N stage of pN2b, pN3b, or pN3c disease, or if receiving neoadjuvant chemotherapy, ypN2b, ypN3b, or ypN3c disease
Radiologic evidence of gross residual disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial will study a new treatment for breast cancer patients involving regional nodal irradiation. Patients will be divided into two groups based on their surgery. They will undergo assessments before and after treatment at specified

Who is the study for?
This trial is for women over 18 with breast cancer who have a life expectancy of more than 5 years and are in good physical condition. They must not be pregnant, breastfeeding, or refuse contraception if of child-bearing potential. Participants should have certain stages of tumor and node involvement but no history of radiation to the neck, breast, or thorax.
What is being tested?
The study tests hypofractionated regional nodal irradiation's effectiveness and safety in breast cancer patients post-surgery. It involves two groups based on axillary surgery extent, with follow-ups from 1-2 weeks up to 3 years after treatment completion.
What are the potential side effects?
While specific side effects are not listed here, typical ones from radiation may include skin changes, fatigue, swelling (lymphedema), pain or stiffness in the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all my pre-disease activities without restriction.
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My cancer has not spread to more than a few nearby lymph nodes.
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My cancer has not spread to distant parts of my body.
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My breast cancer is at an early to mid-stage, according to pathology reports.
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I am female.
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I am 18 years old or older.
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My breast cancer diagnosis is confirmed by tissue analysis.
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My breast cancer is in an early to locally advanced stage.
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I had breast surgery with all cancer removed.
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My breast cancer has spread to certain lymph nodes but not beyond.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to nearby lymph nodes but not to distant parts of my body.
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My scans show visible signs of cancer.
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I have had breast cancer or DCIS in the same breast before.
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I have a history of diseases like lupus with high CK levels.
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My breast cancer is at an advanced stage or inflammatory.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with chronic arm lymphedema
Secondary study objectives
Cosmetic Outcome
Lymphedema requiring intervention
Number acute toxicities
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2: axillary lymph node dissectionExperimental Treatment1 Intervention
Group 2: axillary lymph node dissection (with or without sentinel lymph node procedure). Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.
Group II: Group 1: sentinel lymph node procedure with or without select removal of clipped lymph nodesExperimental Treatment1 Intervention
Group 1: sentinel lymph node procedure with or without select removal of clipped (clinically involved) lymph nodes. Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hypofractionated radiation
2014
N/A
~20

Find a Location

Who is running the clinical trial?

William Beaumont HospitalsLead Sponsor
150 Previous Clinical Trials
112,518 Total Patients Enrolled
1 Trials studying Breast Cancer
3,028 Patients Enrolled for Breast Cancer
Joshua Dilworth, MDPrincipal InvestigatorWilliam Beaumont Hospitals
~9 spots leftby May 2025
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