Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial
Primary Purpose
Breast Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PBI Radiotherapy 6 Gy
PBI Radiotherapy 8 Gy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast, cancer, breast cancer, prone, partial breast irradiation, PBI
Eligibility Criteria
Inclusion Criteria:
Post-menopausal women defined as either:
- at least 2 years without menstrual period
- patients older than 50 with serological evidence of post-menopausal status
- hysterectomized patients of any age with FSH confirmation of post- menopausal status
- pT1 breast cancer, excised with negative margins
- clinically N0 or pN0 or sentinel node negative breast cancer
Exclusion Criteria:
- previous radiation therapy to the ipsilateral breast
- presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
Sites / Locations
- NYU Langone Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PBI Radiotherapy 6 Gy
PBI Radiotherapy 8 Gy
Arm Description
Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
Outcomes
Primary Outcome Measures
Local recurrence rate at 5 years
We will measure non-inferiority to the current 1% local recurrence rate at 5 years
Fibrosis rate at 5 years
We will measure the non-inferiority to the 5 year fibrosis rate of 24-36%
Secondary Outcome Measures
Isolated local/regional recurrences
At the time of local recurrence, patients will undergo disease assessment and will be further grouped as:
Isolated local/regional recurrence Concomitant local/regional and distant recurrence
Full Information
NCT ID
NCT02276885
First Posted
October 24, 2014
Last Updated
September 12, 2023
Sponsor
NYU Langone Health
1. Study Identification
Unique Protocol Identification Number
NCT02276885
Brief Title
Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial
Official Title
Prone Partial Breast Irradiation (PBI): A Prospective Randomized Trial Comparing Five Versus Three Fractions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2014 (Actual)
Primary Completion Date
August 22, 2023 (Actual)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days
Detailed Description
Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator.
The women in this study will receive either 5 or 3 radiation fractions to the tumor bed. We have chosen to study T1 post menopausal women because in this subset: 1) the tumor is small enough to be treated by partial breast radiation 2) the odds of having multicentric disease are low, making it ethical to avoid whole breast irradiation, 3) the most benefit from reducing the radiation schedule from 5 to 3 could be expected.
All patients will receive either 8 Gy x 3 over 5 days, every other day or 6 Gy x 5 over 5 days, on five consecutive days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast, cancer, breast cancer, prone, partial breast irradiation, PBI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PBI Radiotherapy 6 Gy
Arm Type
Experimental
Arm Description
Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
Arm Title
PBI Radiotherapy 8 Gy
Arm Type
Experimental
Arm Description
Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
Intervention Type
Radiation
Intervention Name(s)
PBI Radiotherapy 6 Gy
Other Intervention Name(s)
3D-Conformal, Intensity Modulated Radiation Therapy, Prone partial breast irradiation
Intervention Description
Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days
Intervention Type
Radiation
Intervention Name(s)
PBI Radiotherapy 8 Gy
Other Intervention Name(s)
3D-Conformal, Intensity Modulated Radiation Therapy, Prone partial breast irradiation
Intervention Description
Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day
Primary Outcome Measure Information:
Title
Local recurrence rate at 5 years
Description
We will measure non-inferiority to the current 1% local recurrence rate at 5 years
Time Frame
48 - 60 months
Title
Fibrosis rate at 5 years
Description
We will measure the non-inferiority to the 5 year fibrosis rate of 24-36%
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Isolated local/regional recurrences
Description
At the time of local recurrence, patients will undergo disease assessment and will be further grouped as:
Isolated local/regional recurrence Concomitant local/regional and distant recurrence
Time Frame
48-60 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-menopausal women defined as either:
at least 2 years without menstrual period
patients older than 50 with serological evidence of post-menopausal status
hysterectomized patients of any age with FSH confirmation of post- menopausal status
pT1 breast cancer, excised with negative margins
clinically N0 or pN0 or sentinel node negative breast cancer
Exclusion Criteria:
previous radiation therapy to the ipsilateral breast
presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naamit Gerber, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial
We'll reach out to this number within 24 hrs