← Back to Search

Radiation

APBI for Improved Breast Appearance in Breast Cancer

Phase 2
Recruiting
Led By Jose G Bazan
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have pathologic Tis or T1 disease
Patients must have undergone breast conserving surgery with resulting negative surgical margins (no tumor on ink). Re-excision for negative margins is allowed. Patients with pathologically involved surgical margins are excluded
Must not have
Any prior treatment with radiation therapy, anti-endocrine/hormone therapy, chemotherapy or biologic therapy for the currently diagnosed breast cancer PRIOR to surgical resection
Clinically significant uncontrolled illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post-apbi qd
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a shorter course of radiation therapy (APBI) on breast cancer patients for improved appearance.

Who is the study for?
This trial is for women over 40 with early-stage, hormone-sensitive breast cancer who've had surgery with clear margins and no lymph node involvement. They must not be pregnant, breastfeeding, or have had prior cancer treatments. Participants need to agree to birth control use and understand English or Spanish.
What is being tested?
The study tests a once-daily accelerated partial breast irradiation (APBI) regimen over consecutive business days for five treatments. APBI targets only the affected area of the breast rather than the whole breast, aiming for better cosmetic outcomes in low-risk patients.
What are the potential side effects?
While specific side effects are not listed here, APBI may include skin changes like redness or irritation, fatigue, discomfort at the treatment site, and potential long-term changes in breast size or shape.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is in the earliest stage.
Select...
I had breast surgery with all cancer removed, confirmed by tests.
Select...
My biopsy shows my cancer responds to hormones.
Select...
I am 40 years old or older.
Select...
I am female.
Select...
My cancer is of the epithelial type, not lymphoma or sarcoma.
Select...
My breast cancer is at an early stage (stage 0 or IA).
Select...
I can read and understand either English or Spanish.
Select...
My biopsy shows my cancer is not HER2 positive according to specific guidelines.
Select...
My doctor rated my appearance as good or excellent after my lumpectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have received treatments like radiation or hormone therapy for my current breast cancer before surgery.
Select...
I do not have any uncontrolled serious illnesses.
Select...
I have been diagnosed with Paget's disease of the nipple.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post-apbi qd
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-apbi qd for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of women that rate the cosmetic appearance of the breast as acceptable ("excellent" or "good")
Secondary study objectives
Cosmetic outcome assessed by the physician post-APBI QD
Cosmetic outcome by the patient post-APBI QD
Disease-free survival
+6 more

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: Supportive care (APBI)Experimental Treatment1 Intervention
Patients undergo APBI QD on consecutive business days for 5 treatments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Accelerated Partial Breast Irradiation
2015
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,532 Total Patients Enrolled
42 Trials studying Breast Cancer
4,877 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,916 Previous Clinical Trials
41,011,797 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,255 Patients Enrolled for Breast Cancer
Jose G BazanPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
18 Total Patients Enrolled
~23 spots leftby Nov 2025
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