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Brachytherapy

PBI Radiotherapy for Breast Cancer

N/A
Waitlist Available
Led By Naamit Gerber, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically N0 or pN0 or sentinel node negative breast cancer
pT1 breast cancer, excised with negative margins
Must not have
Previous radiation therapy to the ipsilateral breast
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new, more intensive radiation therapy regimen to see if it is as effective and safe as the standard treatment.

Who is the study for?
This trial is for post-menopausal women with a specific early-stage breast cancer (pT1), who have had the tumor surgically removed with clear margins and no spread to lymph nodes. Women must not have had previous radiation on the same breast or a high proportion of DCIS, which suggests extensive intraductal component.
What is being tested?
The study is comparing two different doses of partial breast irradiation (PBI) radiotherapy in treating breast cancer: one group receives 8 Gy over three sessions every other day for five days, while another gets 6 Gy over five consecutive days. The goal is to see if the higher dose given less frequently is as safe and effective.
What are the potential side effects?
Potential side effects from PBI radiotherapy can include skin irritation at the treatment site, fatigue, changes in breast size or shape, pain or discomfort in the treated area, and rarely more serious complications like heart problems or secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer has not spread to my lymph nodes.
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My breast cancer was removed with clear margins.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had radiation therapy on the same side breast before.

Timeline

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

Treatment Details

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
Group I: PBI Radiotherapy 8 GyExperimental Treatment1 Intervention
Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
Group II: PBI Radiotherapy 6 GyExperimental Treatment1 Intervention
Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,495 Total Patients Enrolled
37 Trials studying Breast Cancer
7,104 Patients Enrolled for Breast Cancer
Naamit Gerber, MDPrincipal InvestigatorNYU Langone Medical Center
2 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Breast Cancer
40 Patients Enrolled for Breast Cancer
Carmen Perez, MDPrincipal InvestigatorNYU Langone Medical Center
2 Previous Clinical Trials
726 Total Patients Enrolled
2 Trials studying Breast Cancer
726 Patients Enrolled for Breast Cancer

Media Library

PBI Radiotherapy 6 Gy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02276885 — N/A
~29 spots leftby Nov 2025
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