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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 15Eligibility criteria met