NCT02276885

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
4mo left

Started Oct 2014

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Oct 2014Dec 2026

First Submitted

Initial submission to the registry

October 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

October 28, 2014

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 31, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2026

Expected
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

9.1 years

First QC Date

October 24, 2014

Results QC Date

December 6, 2024

Last Update Submit

December 8, 2025

Conditions

Breast Cancer

Keywords

breastcancerbreast cancerpronepartial breast irradiationPBI

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Grade 2 or 3 Fibrosis

    60 months

Secondary Outcomes (6)

  • Rate of Isolated Local/Regional Recurrences

    1 year post randomization

  • Rate of Concomitant Local/Regional and Distant Recurrences

    1 year post randomization

  • Rate of Isolated Local/Regional Recurrences

    2 years post randomization

  • Rate of Concomitant Local/Regional and Distant Recurrences

    2 years post randomization

  • Rate of Isolated Local/Regional Recurrences

    3 years post randomization

  • +1 more secondary outcomes

Study Arms (2)

PBI Radiotherapy 6 Gy

EXPERIMENTAL

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

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

Radiation: PBI Radiotherapy 8 Gy

Interventions

PBI Radiotherapy 6 GyRADIATION

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

Also known as: 3D-Conformal, Intensity Modulated Radiation Therapy, Prone partial breast irradiation
PBI Radiotherapy 6 Gy
PBI Radiotherapy 8 GyRADIATION

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

Also known as: 3D-Conformal, Intensity Modulated Radiation Therapy, Prone partial breast irradiation
PBI Radiotherapy 8 Gy

Eligibility Criteria

Age50 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

Radiotherapy, ConformalRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-AssistedRadiotherapyTherapeutics

Results Point of Contact

Title
Naamit Gerber, MD
Organization
NYU Langone Health
Naamit.Gerber@nyulangone.org
2127316338

Study Officials

  • Naamit Gerber, MD

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2014

First Posted

October 28, 2014

Study Start

October 28, 2014

Primary Completion

December 7, 2023

Study Completion (Estimated)

December 7, 2026

Last Updated

December 30, 2025

Results First Posted

December 31, 2024

Record last verified: 2025-12

Locations

US(1)