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Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study
The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.
* In this study, radiotherapy is given only to a portion of the breast around the tumor bed using external radiation treatments. This approach is called "partial breast irradiation". * Participants will undergo a planning session for the radiation treatments. This planning will be done by CT scan days or weeks before the start of treatment. This planning process is the same as that used to plan conventional radiation therapy treatments. * Radiation therapy will begin 4-12 weeks after the last surgery of the breast in individuals not receiving chemotherapy first. For individuals receiving chemotherapy before radiation therapy, radiation therapy will start 2-6 weeks after ending chemotherapy. * We will be studying three levels of radiation doses to see which is best. The dose the participant receives will depend upon when they are enrolled on the trial. * Participants will receive radiation treatment twice each day for 4 or 5 treatment days, with an overall treatment time of one week.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Start Date
September 1, 2003
Primary Completion Date
June 1, 2021
Completion Date
June 1, 2021
Last Updated
November 14, 2022
324
ACTUAL participants
Partial Breast Irradiation using 32 Gy / 8 fractions
RADIATION
Partial Breast Irradiation using 36 Gy / 9 fractions
RADIATION
Partial Breast Irradiation using 40 Gy /10 fractions
RADIATION
Lead Sponsor
Massachusetts General Hospital
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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