Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial

Breast Cancer Clinical Trial

Official title:

Prone Partial Breast Irradiation (PBI): A Prospective Randomized Trial Comparing Five Versus Three Fractions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02276885
• Other study ID #: 14-01306
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: August 2026

Study information

• Verified date: September 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: August 2026
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Post-menopausal women defined as either:

1. at least 2 years without menstrual period

2. patients older than 50 with serological evidence of post-menopausal status

3. 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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• PBI Radiotherapy 6 Gy
Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days
• PBI Radiotherapy 8 Gy
Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence rate at 5 years	We will measure non-inferiority to the current 1% local recurrence rate at 5 years	48 - 60 months
Primary	Fibrosis rate at 5 years	We will measure the non-inferiority to the 5 year fibrosis rate of 24-36%	60 months
Secondary	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	48-60 months