← Back to Search

Radiation Therapy

Radiation Therapy for Early-Stage Breast Cancer

Phase 2
Waitlist Available
Led By Eric A Strom
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
Patients with stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less
The target lumpectomy cavity/whole breast reference volume must be < 30% based on the postoperative/pre-enrollment CT scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

This trial studies how well radiation therapy works in treating patients with early-stage breast cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

Who is the study for?
This trial is for women over 18 with stage 0-II breast cancer, where the tumor is no larger than 3 cm and located in one area. They must have had a lumpectomy with clear margins and be at low risk of recurrence if they've had non-breast cancers before. Men, pregnant or breastfeeding women, those with advanced cancer stages or certain other conditions are excluded.Check my eligibility
What is being tested?
The study tests high-dose radiation therapy aimed directly at the tumor to see if it's more effective and less harmful to healthy tissue. It involves Accelerated Partial Breast Irradiation (APBI) using Proton Beam Radiation Therapy while also assessing patients' quality of life.See study design
What are the potential side effects?
Potential side effects may include skin changes like redness or irritation, fatigue, breast pain, swelling in the treated area, and rare risks such as heart problems or secondary cancers due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer is in an early stage and, if stage II, my tumor is 3 cm or less.
Select...
The area treated by lumpectomy is less than 30% of my whole breast.
Select...
I had a lumpectomy with clear margins.
Select...
My breast cancer is either DCIS or invasive adenocarcinoma.
Select...
My cancer is in one spot and the tumor is 3 cm or smaller.
Select...
My breast cancer diagnosis included checking the lymph nodes under my arm.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-Reported Cosmesis Score
Secondary outcome measures
Percent of Patients with Local Failure
Rate of CTCAE Grade 3+ Confluent Moist Desquamation

Side effects data

From 2021 Phase 2 trial • 200 Patients • NCT02526498
22%
Musculoskeletal and connective tissue disorders
20%
Injury, poisoning and procedural complications
18%
Reproductive system and breast disorder
15%
Breast Pain
14%
Dermatitis radiation
14%
Fibrosis deep connective tissue
10%
Superficial soft tissue fibrosis
6%
Seroma
5%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (APBI Using HDR Brachytherapy)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (APBI)Experimental Treatment3 Interventions
Within 10 weeks of last breast cancer surgery, patients undergo APBI delivered with proton radiation BID for 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Accelerated Partial Breast Irradiation
2015
Completed Phase 2
~200
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,308 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,171 Total Patients Enrolled
941 Trials studying Breast Cancer
1,543,396 Patients Enrolled for Breast Cancer
Eric A StromPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer
2010. "Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01245712.
All > Breast Cancer Houston > Texas
~78 spots leftby Dec 2032
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top