Breast Re-irradiation After Second Ipsilateral Lumpectomy

Part of paid clinical trials in Boca Raton, Florida.

Sponsor
Youssef Zeidan
Study ID
NCT06867484
Status
Recruiting

Conditions

  • Breast Cancer
  • Cancer
  • Cancer of the Breast
  • ER+ Breast Cancer
  • Estrogen-receptor-positive Breast Cancer
  • HER2-negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intensity modulated radiation therapy (IMRT) — RADIATION
    40 Gy total in 15 consecutive weekday sessions to the partial breast

Study Details

The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.

Key Dates

Start date
Oct 27, 2025
Status verified
Nov 2025
Primary completion
May 31, 2028
Completion
May 31, 2033

Study Design

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

Arms

  • Experimental: Partial Breast Irradiation (PBI)

Primary Outcome Measure

Rate of grade 3 or higher treatment-related adverse events (AEs) [ Time Frame: 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Lynn Cancer Institute at Baptist Health, Inc.Boca RatonFlorida33486
Youssef Zeidan, M.D., Ph.D.
(561) 955-5966
MCI Multisite Research Program
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176
Joseph Panoff, M.D.
(786) 596-2000
MCI Multisite Research Program

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