Breast CancerNCT02276885
Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial
A study testing PBI Radiotherapy 6 Gy and PBI Radiotherapy 8 Gy in people with Breast Cancer, run by NYU Langone Health at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 50 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PBI Radiotherapy 6 Gy and PBI Radiotherapy 8 Gy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2014to 7 Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women defined as either:
- at least 2 years without menstrual period
- patients older than 50 with serological evidence of post-menopausal status
- hysterectomized patients of any age with FSH confirmation of post- menopausal status
- pT1 breast cancer, excised with negative margins. Criteria for low risk-pTis:
- Screen-detected
Show all 10Show fewer
- Low to intermediate nuclear grade
- < 2.5cm in size
- Resected with negative margins at >3mm)
- clinically N0 or pN0 or sentinel node negative breast cancer
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: Prone Partial Breast Irradiation (PBI): A Prospective Randomized Trial Comparing Five Versus Three Fractions
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
Read the 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
- Being tested
- PBI Radiotherapy 6 Gy, PBI Radiotherapy 8 Gy
- Keywords
- breast, cancer, breast cancer, prone, partial breast irradiation, PBI
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBI Radiotherapy 6 GyRadiation
Also called 3D-Conformal, Intensity Modulated Radiation Therapy, Prone partial breast irradiation
Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days
PBI Radiotherapy 8 GyRadiation
Also called 3D-Conformal, Intensity Modulated Radiation Therapy, Prone partial breast irradiation
Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day
| Study group | Role | What they receive |
|---|---|---|
| PBI Radiotherapy 6 Gy | Experimental | Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days Receives: Radiation: PBI Radiotherapy 6 Gy |
| PBI Radiotherapy 8 Gy | Experimental | Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day Receives: Radiation: PBI Radiotherapy 8 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Grade 2 or 3 Fibrosis
Measured: 60 months
Secondary outcomes (6)
Rate of Isolated Local/Regional Recurrences
Measured: 1 year post randomization
Rate of Concomitant Local/Regional and Distant Recurrences
Measured: 1 year post randomization
Rate of Isolated Local/Regional Recurrences
Measured: 2 years post randomization
Rate of Concomitant Local/Regional and Distant Recurrences
Measured: 2 years post randomization
Rate of Isolated Local/Regional Recurrences
Measured: 3 years post randomization
Rate of Concomitant Local/Regional and Distant Recurrences
Measured: 3 years post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study start28 Oct 2014
- Primary completion7 Dec 2023
- Study completion7 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naamit Gerber, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276885
- Sponsor's protocol ID
- 14-01306
- Status last verified
- Dec 2025
- First submitted
- 24 Oct 2014
- Last updated
- 30 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Partial Breast Irradiation (PBI): A Prospective Randomized Trial Comparing Five Versus Three Fractions
- ClinicalTrials.gov ID
- NCT02276885
- Acronym / sponsor ID
- 14-01306
- Conditions
- Breast Cancer
- Keywords
- breast, cancer, breast cancer, prone, partial breast irradiation, PBI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 284 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 28 Oct 2014 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2026 (estimated)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Posted 31 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBI Radiotherapy 6 Gy | Experimental | Radiation: PBI Radiotherapy 6 GyProne partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days |
| PBI Radiotherapy 8 Gy | Experimental | Radiation: PBI Radiotherapy 8 GyProne partial breast irradiation of 8 Gy x 3 over 5 days, every other day |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Post-menopausal women defined as either:
- pT1 breast cancer, excised with negative margins. Criteria for low risk-pTis:
- clinically N0 or pN0 or sentinel node negative breast cancer
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBI Radiotherapy 6 GyAlso: 3D-Conformal, Intensity Modulated Radiation Therapy, Prone partial breast irradiationPatients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days | Radiation | PBI Radiotherapy 6 Gy |
| PBI Radiotherapy 8 GyAlso: 3D-Conformal, Intensity Modulated Radiation Therapy, Prone partial breast irradiationPatients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day | Radiation | PBI Radiotherapy 8 Gy |
Primary outcome
Percentage of Participants With Grade 2 or 3 Fibrosis
Time frame: 60 months
6 secondary outcomes
Rate of Isolated Local/Regional Recurrences
Time frame: 1 year post randomization
Rate of Concomitant Local/Regional and Distant Recurrences
Time frame: 1 year post randomization
Rate of Isolated Local/Regional Recurrences
Time frame: 2 years post randomization
Rate of Concomitant Local/Regional and Distant Recurrences
Time frame: 2 years post randomization
Rate of Isolated Local/Regional Recurrences
Time frame: 3 years post randomization
Rate of Concomitant Local/Regional and Distant Recurrences
Time frame: 3 years post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naamit Gerber, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBI Radiotherapy 6 Gy and PBI Radiotherapy 8 Gy in people with Breast Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Grade 2 or 3 Fibrosis (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.