Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

Part of paid clinical trials in New York, New York.

Sponsor
University Health Network, Toronto
Study ID
NCT05592938
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • rPBI — RADIATION
    External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week

Study Details

Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\<13% grade \>3 toxicity).

Key Dates

Start date
Jun 27, 2023
Status verified
May 2026
Primary completion
Jun 27, 2027
Completion
Jun 27, 2027

Study Design

Enrollment
171 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rPBI
    26Gy in 5 daily fractions over 1-week

Primary Outcome Measure

Grade ≥3 toxicity associated with treatment [ Time Frame: During accrual period, up to 3 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Eileen Connolly, MD
[email protected]
646-317-4244
Eileen Connolly, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Naamit K Gerber, MD
[email protected]
212-731-5304
Naamit K Gerber, MD (PRINCIPAL_INVESTIGATOR)
Virgina Community University Massey Comprehensive Cancer CenterRichmondVirginia23298-0037
Doug Arthur, M.D.
[email protected]
804.828.0539
Doug Arthur, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Columbia University Medical Center· New York, NYNYU Langone Health· New York, NYVirgina Community University Massey Comprehensive Cancer Center· Richmond, VA

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