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Completed Not applicable Interventional Results available

External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks

ClinicalTrials.gov ID: NCT01581619

Public ClinicalTrials.gov record NCT01581619. 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 23, 2026, 9:52 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 I Study of Once-Daily External-Beam Partial-Breast Irradiation (PBI) for Selected Patients With Early Invasive N0 or Non-Invasive Breast Cancer

Brief summary

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

Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy. One question regarding radiation therapy for early stage breast cancer is whether the entire breast needs to be radiated or only a more limited area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed (called the "tumor bed"). The investigators hope the option of PBI will reduce side effects from radiation therapy and shorten the radiation treatment process when compared to WBI, since only part of the breast is being treated. The investigators also hope that this will make such treatment more convenient for breast cancer patients. The purpose of the study is to evaluate the the safety of external-beam PBI in selected early breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators will also evaluate the local control and the cosmetic results.

Study identification

NCT ID
NCT01581619
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
54 participants

Conditions and interventions

Conditions

Interventions

Radiation

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
Apr 30, 2012
Primary completion
Jul 31, 2016
Completion
Jul 31, 2019
Last update posted
Nov 1, 2020

2012 – 2019

United States locations

U.S. sites
4
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Beth Isreal Deaconness Medical Center Boston Massachusetts 02215
Brigham and Women's Hosptial Boston Massachusetts 02215
Dana-Farber Cancer Institute Boston Massachusetts 02215
Massachusetts General Hospital Boston Massachusetts 02215

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 NCT01581619, 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 Nov 1, 2020 · Synced Sep 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01581619 live on ClinicalTrials.gov.

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