Clinical trial NCT02276885: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast
cancer
breast cancer
prone
partial breast irradiation
PBI
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 284
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Percentage of Participants With Grade 2 or 3 Fibrosis
timeFrame: 60 months
Secondary outcomes:
measure: Rate of Isolated Local/Regional Recurrences
timeFrame: 1 year post randomization
measure: Rate of Concomitant Local/Regional and Distant Recurrences
timeFrame: 1 year post randomization
measure: Rate of Isolated Local/Regional Recurrences
timeFrame: 2 years post randomization
measure: Rate of Concomitant Local/Regional and Distant Recurrences
timeFrame: 2 years post randomization
measure: Rate of Isolated Local/Regional Recurrences
timeFrame: 3 years post randomization
measure: Rate of Concomitant Local/Regional and Distant Recurrences
timeFrame: 3 years post randomization
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Naamit Gerber, MD
role: PRINCIPAL_INVESTIGATOR
References: