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Active, not recruiting Phase 2 Interventional

Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer

ClinicalTrials.gov ID: NCT01203839

Public ClinicalTrials.gov record NCT01203839. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 5:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Study of Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Currently the standard of care is to treat early stage invasive breast cancer or ductal carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as "breast-conserving therapy" (BCT). The traditional method of giving radiation therapy after a lumpectomy is to the whole breast. However the investigators do not know if the whole breast needs to be receive radiation to better control your cancer or only a more limited area of the breast surrounding the tumor. The purpose of this study is to see the side effects of delivering partial breast irradiation (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the area of the breast where the cancer was removed. Another purpose of this study is to look long term at the rate at which cancer comes back in the same breast after PBI. WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a day, five days a week, for 2 weeks. In this study the investigators will learn about the good and bad effects of PBI radiation therapy. In this study, the investigators will also learn about how the breast looks after surgery and radiation therapy.

Study identification

NCT ID
NCT01203839
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
110 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2010
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026
Last update posted
Oct 5, 2025

2010 – 2026

United States locations

U.S. sites
8
U.S. states
2
U.S. cities
8
Facility City State ZIP Site status
Memorial Sloan Kettering at Basking Ridge (Follow-up Only) Basking Ridge New Jersey 07920
Memorial Sloan Kettering Monmouth (Follow-up Only) Middletown New Jersey 07748
Memorial Sloan Kettering Bergen (Follow-up Only) Montvale New Jersey 07645
Memorial Sloan Kettering Cancer Center @ Suffolk (Follow-up Only) Commack New York 11725
Memorial Sloan Kettering Westchester (Follow-up Only) Harrison New York 10604
Memorial Sloan Kettering Cancer Center New York New York 10065
Memorial Sloan Kettering at Mercy Medical Center (Follow-up Only) Rockville Centre New York
Memorial Sloan Kettering Nassau Uniondale New York 11553

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01203839, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 5, 2025 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01203839 live on ClinicalTrials.gov.

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