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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
Must not have
T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer
More than 3 histologically positive axillary nodes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My breast cancer is at an advanced stage (larger than 3 cm, or stage III/IV).
Select...
I have more than 3 lymph nodes in my armpit area affected by cancer.
Select...
My breast cancer is not the common type; it's a rare form like sarcoma or lymphoma.
Select...
I am a man.
Select...
I have cancer in both breasts at the same time.
Select...
My surgery showed that cancer may still be at the edge of the removed tissue.
Select...
My treatment plan includes radiation therapy to the lymph nodes.
Select...
I have Paget's disease of the nipple.
Select...
My breast cancer is in more than one area or is spread out.
Select...
I have had radiation therapy on the breast with cancer before.
Select...
I agree to use effective birth control without hormones during treatment.
Select...
I have a collagen vascular disease like dermatomyositis, lupus, or scleroderma.
Select...
I have suspicious lymph nodes near my breast without confirmed cancer.
Select...
My cancer has spread outside the lymph nodes in my armpit.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient-Reported Cosmesis Score
Secondary study objectives
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%
Fibrosis deep connective tissue
14%
Dermatitis radiation
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,074 Previous Clinical Trials
1,803,391 Total Patients Enrolled
147 Trials studying Breast Cancer
63,202 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,380 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,132 Patients Enrolled for Breast Cancer
Eric A StromPrincipal InvestigatorM.D. Anderson Cancer Center
~72 spots leftby Dec 2032
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