CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 54 enrolled
Drug / intervention
External Beam Partial-Breast Irradiationradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01581619
NCT01581619N/ACompleted

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

Massachusetts General Hospital·interventional·Posted Apr 20, 2012·Updated Nov 2, 2020

In Brief

A clinical study evaluating External Beam Partial-Breast Irradiation for Breast Cancer. Completed, enrolled 54 participants across 4 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2012
Enrollment StartMay 1, 2012
Primary CompletionAug 1, 2016
Study CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 14.2 years ago

Interventions

External Beam Partial-Breast Irradiationradiation

40 Gy in ten daily fractions over two weeks