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

NCT ID: NCT02276885

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-28
• Study Completion Date: 2026-12-07

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

Conditions

Breast Cancer

Keywords

PBI; breast; cancer; breast cancer; prone; partial breast irradiation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PBI Radiotherapy 6 Gy

Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days

Group Type: EXPERIMENTAL

PBI Radiotherapy 6 Gy

Intervention Type: RADIATION

Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days

PBI Radiotherapy 8 Gy

Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day

Group Type: EXPERIMENTAL

PBI Radiotherapy 8 Gy

Intervention Type: RADIATION

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

Interventions

PBI Radiotherapy 6 Gy

Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days

Intervention Type: RADIATION

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

Intervention Type: RADIATION

Other Intervention Names

3D-Conformal; Intensity Modulated Radiation Therapy; Prone partial breast irradiation; 3D-Conformal; Intensity Modulated Radiation Therapy; Prone partial breast irradiation

Eligibility Criteria

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. Criteria for low risk-pTis:

1. Screen-detected

2. Low to intermediate nuclear grade

3. < 2.5cm in size

4. Resected with negative margins at >3mm)

• 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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naamit Gerber, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

NYU Langone Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14-01306

Identifier Type: -

Identifier Source: org_study_id