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

• ClinicalTrials.gov Identifier: NCT02276885
• Recruitment Status: Recruiting
• First Posted: October 28, 2014
• Last Update Posted: October 23, 2020
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

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

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Radiation: PBI Radiotherapy 6 Gy; Radiation: PBI Radiotherapy 8 Gy	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 284 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prone Partial Breast Irradiation (PBI): A Prospective Randomized Trial Comparing Five Versus Three Fractions
• Actual Study Start Date: August 2014
• Estimated Primary Completion Date: June 11, 2021
• Estimated Study Completion Date: September 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: PBI Radiotherapy 6 Gy; Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days	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; Other Names: 3D-Conformal; Intensity Modulated Radiation Therapy; Prone partial breast irradiation
Experimental: PBI Radiotherapy 8 Gy; Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day	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; Other Names: 3D-Conformal; Intensity Modulated Radiation Therapy; Prone partial breast irradiation

Outcome Measures

Primary Outcome Measures :

1. Local recurrence rate at 5 years [ Time Frame: 48 - 60 months ]
   We will measure non-inferiority to the current 1% local recurrence rate at 5 years
2. Fibrosis rate at 5 years [ Time Frame: 60 months ]
   We will measure the non-inferiority to the 5 year fibrosis rate of 24-36%

Secondary Outcome Measures :

1. Isolated local/regional recurrences [ Time Frame: 48-60 months ]

   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

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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
• 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)

Contacts and Locations

Contacts

Contact: Carmen Perez, M.D.; (212) 731-5003; carmen.perez@nyumc.org

Locations

United States, New York

NYU Langone Medical Center; Recruiting

New York, New York, United States, 10016

Contact: Carmen Perez, M.D. 212-731-5003 carmen.perez@nyumc.org

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: Carmen Perez, MD; NYU Langone Medical Center

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02276885
• Other Study ID Numbers: 14-01306
• First Posted: October 28, 2014
• Last Update Posted: October 23, 2020
• Last Verified: October 2020

• 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

Keywords provided by NYU Langone Health:

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

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases