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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276885
Recruitment Status : Recruiting
First Posted : October 28, 2014
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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

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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

Resource links provided by the National Library of Medicine


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




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




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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276885


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

Locations
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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
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Principal Investigator: Carmen Perez, MD NYU Langone Medical Center
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02276885    
Other Study ID Numbers: 14-01306
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

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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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases