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Radiation Therapy

Radiation Therapy Schedules for Breast Cancer

Phase 2

Recruiting

Led By Karen Hoffman, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If receiving preoperative radiation therapy: History of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration, and the patient must have no evidence of disease for this prior non-breast cancer

If receiving preoperative radiation therapy: Pathologically-confirmed invasive breast cancer. The clinical stage must be T0-T3, N0-N3b

Must not have

If receiving preoperative radiation therapy: Prior diagnosis of invasive breast cancer in the contralateral breast

If receiving postoperative radiation therapy: Clinical or pathologic evidence for distant metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 126 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two different treatment schedules for women who need radiation therapy to their lymph nodes as part of their breast cancer treatment. One schedule takes 6 weeks and the other takes 4 weeks. The purpose of the trial is to see if the shorter schedule will lower the risk of developing arm swelling, also known as lymphedema, after radiation treatment.

Who is the study for?

This trial is for adults with invasive breast cancer who are planning or have had surgery and recommend radiation to lymph nodes near the breast. They must not be pregnant, have no other active cancers, and should not have received certain prior treatments that overlap with this study's area.

What is being tested?

The trial tests if a shorter 3-week course of radiation therapy to the lymph nodes is as effective in preventing cancer recurrence as the conventional 5-week course. It also examines side effects like arm swelling.

What are the potential side effects?

Potential side effects include skin changes, fatigue, discomfort at the treatment site, and arm swelling (lymphedema), which will be closely monitored during and after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had cancer other than breast cancer, treated it fully, and now show no signs of that cancer.

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My breast cancer is confirmed and falls within early to mid stages before spreading widely.

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I am scheduled for a mastectomy and an axillary evaluation after preoperative radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had breast cancer in my other breast before starting preoperative radiation.

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I have signs of cancer spread to distant parts of my body after surgery.

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I am pregnant and will undergo radiation therapy after surgery.

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I am cognitively impaired and will undergo a brief exam before postoperative radiation.

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I will have a cognitive assessment before my preoperative radiation therapy.

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I am pregnant and receiving preoperative radiation therapy.

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My breast cancer is at stage T4 and I am receiving preoperative radiation therapy.

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My breast cancer has spread to nearby lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 126 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 126 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 126 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lymphedema rate as assessed by perometry

Secondary study objectives

Volume of affected and unaffected arm as assessed by perometry

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

Active Control

Group I: Arm I: Hypofractionated Regional Nodal Irradiation (RNI)Experimental Treatment4 Interventions

Patients undergo hypofractionated RNI in 15 fractions 5 consecutive days a week for 3 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.

Group II: Arm II: Standard Regional Nodal Irradiation (RNI)Active Control4 Interventions

Patients undergo standard RNI in 25 fractions 5 consecutive days a week for 5 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated Radiation Therapy

2016

Completed Phase 3

~130

0 / 11Eligibility criteria met