Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06902311
Phase
PHASE2
Status
Recruiting

Conditions

  • Breast Cancer
  • DCIS
  • Ductal Carcinoma in Situ
  • Early-stage Breast Cancer

Eligibility Criteria

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

Interventions

  • Breast Radiotherapy — RADIATION
    The tumor bed boost when given at the same time (called a simultaneous integrated boost, SIB) with whole breast irradiation (WBI).

Study Details

This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy. The FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.

Key Dates

Start date
Feb 19, 2025
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

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

Arms

  • Experimental: WBI-SIB
    Five-fraction whole breast irradiation (WBI) with simultaneous integrated tumor bed boost (SIB).

Primary Outcome Measure

Rate of any moderate-marked adverse effects [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27599
Jessica Buddenbaum
919-966-4432
Dana Casey, MD (PRINCIPAL_INVESTIGATOR)

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