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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48-60 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My breast cancer has not spread to my lymph nodes.

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My breast cancer was removed with clear margins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48-60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48-60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48-60 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Fibrosis rate at 5 years

Local recurrence rate at 5 years

Secondary outcome measures

Isolated local/regional recurrences

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,441 Total Patients Enrolled

37 Trials studying Breast Cancer

6,947 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

Frequently Asked Questions

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

Are further participants currently being sought for this research endeavor?

"As viewed on clinicaltrials.gov, this trial is no longer enrolling candidates; it was initially posted in August 2014 and the most recent update occurred May 25th 2022. However, an abundance of other trials are actively recruiting participants at present - 2601 to be exact."

Answered by AI

Does the study recruit individuals aged 45 and over?

"The minimum age for enrolment in this trial is 50, with a maximum allowable age of 90."

Answered by AI

Is it possible to be admitted into this health study?

"With a target sample size of 320, this clinical trial is accepting those aged between 50 and 90 years old who have been diagnosed with breast cancer."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial

2014. "Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02276885.

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