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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years after completing radiation therapy.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years after completing radiation therapy

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Scores of Either <2.5 or >=2.5 on the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis

Secondary outcome measures

Panel Physicians Rated Cosmesis

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

~3070

Hypofractionated Radiation Therapy

2016

Completed Phase 2

~130

Whole Breast Irradiation

2017

N/A

~160

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,480 Total Patients Enrolled

148 Trials studying Breast Cancer

63,286 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,852 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Benjamin Smith, MDPrincipal InvestigatorM.D. Anderson Cancer Center

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential hazards associated with Arm I (HF-WBI) for participants?

"Our analysis of Arm I (HF-WBI) yielded a score of 2 on the safety scale. This is because there exists some evidence indicating its security, however no conclusive results have been observed with regards to efficacy."

Answered by AI

How many U.S.-based hospitals are engaged in executing this research?

"Currently, 8 medical centres are recruiting participants for this trial. These locations range from Gilbert to Orlando and Conroe amongst other places nearby. To reduce the burden of travel, it is ideal to choose a site closest to your residence if you participate in the study."

Answered by AI

Does this research project still accept participants?

"According to clinicaltrials.gov, this research endeavour is not currently recruiting participants. First posted on February 8th 2011 and last modified on August 11th 2023, applications for inclusion in the project are no longer accepted at present. Fortunately, there exists 4790 other trials that actively welcome volunteers as of now."

Answered by AI

Recent research and studies

JAMA OncologyJournal

Acute and Short-term Toxic Effects of Conventionally Fractionated Vs Hypofractionated Whole-breast Irradiation

Shaitelman, Simona F., Pamela J. Schlembach, Isidora Arzu, Matthew Ballo, Elizabeth S. Bloom, Daniel Buchholz, Gregory M. Chronowski, et al.. 2015. “Acute and Short-term Toxic Effects of Conventionally Fractionated Vs Hypofractionated Whole-breast Irradiation”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2015.2666.

clinicaltrials.govStudy

Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer

2011. "Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01266642.