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Radiation Therapy

Radiation Therapy for Breast Cancer

Phase 2
Waitlist Available
Led By Benjamin Smith, 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
Pathologically confirmed ductal carcinoma in situ of the breast or early invasive breast cancer defined as pathologic stage Tis, T1, or T2, N0, N1mic, or N1a
Final surgical margins must be negative
Must not have
Pathologic or clinical evidence for a stage T3 or T4 breast cancer
Clinical or pathologic evidence for distant metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years after completing radiation therapy.
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two types of radiation therapy to see which is more effective in treating patients with ductal breast carcinoma in situ or early invasive breast cancer.

Who is the study for?
This trial is for patients who've had breast-conserving surgery for ductal carcinoma in situ or early invasive breast cancer, with no tumor cells at the surgical margin. It's not open to those pregnant, with bilateral or advanced-stage breast cancer, more than 4 affected lymph nodes, metastases, previous breast cancers or radiation therapy in relevant areas.
What is being tested?
The study compares two types of radiation therapy: hypofractionated (higher doses over a shorter period) and standard treatment. The goal is to see if the shorter-duration treatment is as effective while potentially causing fewer side effects.
What are the potential side effects?
Radiation therapy can cause skin irritation, fatigue, swelling in treated areas, and changes to breast appearance. Long-term risks include heart problems and secondary cancers but vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is in the early stages and has not spread widely.
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My last surgery showed no cancer at the edges of the tissue removed.
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I had surgery to remove part of my breast.
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My radiation treatment is planned for the whole breast only.
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I had cancer other than breast cancer, was treated, and now have no signs of it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast cancer is at an advanced stage (T3 or T4).
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My cancer has spread to distant parts of my body.
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I have been diagnosed with breast cancer before.
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I have been diagnosed with cancer in both breasts.
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My cancer has spread to 4 or more lymph nodes under my arm.
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I have received radiation therapy to specific parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years after completing radiation therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years after completing radiation therapy 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 Scores of Either <2.5 or >=2.5 on the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis
Secondary study objectives
Panel Physicians Rated Cosmesis

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 (HF-WBI)Experimental Treatment6 Interventions
Patients undergo HF-WBI comprising external beam RT 5 days a week for approximately 3 weeks.
Group II: Arm II (CF-WBI)Active Control5 Interventions
Patients undergo CF-WBI comprising external beam RT 5 days a week for approximately 5 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
2006
Completed Phase 3
~3300
Hypofractionated Radiation Therapy
2016
Completed Phase 3
~130
Whole Breast Irradiation
2017
N/A
~160

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,507 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,869 Total Patients Enrolled
Benjamin Smith, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Benjamin D SmithPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
928 Total Patients Enrolled

Media Library

Conventionally Fractionated Whole Breast Irradiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01266642 — Phase 2
Breast cancer Research Study Groups: Arm I (HF-WBI), Arm II (CF-WBI)
Breast cancer Clinical Trial 2023: Conventionally Fractionated Whole Breast Irradiation Highlights & Side Effects. Trial Name: NCT01266642 — Phase 2
Conventionally Fractionated Whole Breast Irradiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01266642 — Phase 2
~20 spots leftby Dec 2025
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