Recruiting
Phase 2

WBI with SIB

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06902311

Conditions

Breast Cancer

Early-stage Breast Cancer

Ductal Carcinoma in Situ

DCIS

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Breast Radiotherapy

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Early-stage Breast Cancer

Ductal Carcinoma in Situ

DCIS

Study ID

NCT06902311

Start date

Feb 19, 2025

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

  • Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  • Women ≥ 50 years of age with confirmed de novo invasive carcinoma of breast or ductal carcinoma in situ.
  • Subjects with completed breast-conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
  • Subjects planned to receive either SOC whole breast 3D conformal radiation therapy (3D CRT) or SOC whole breast intensity modulated radiation therapy (IMRT) with standard dose tumor bed boost.
  • Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, per the discretion of the treating radiation oncologist.
  • Enrollment in another clinical trial is allowed if there is no interference with interventions on this trial per discretion of the Principal Investigator.

Exclusion Criteria:

  • Receipt of concurrent breast reduction involving tissue rearrangement in the lumpectomy cavity (so that boost cannot be accurately targeted).
  • Synchronous bilateral breast cancer requiring bilateral radiation therapy.
  • Clinical or imaging evidence of distant metastases.
  • Prior ipsilateral breast or thoracic radiation.
  • Autoimmune conditions
  • Collagen Vascular Disease (such as systemic lupus erythematosus, scleroderma, dermatomyositis, among others)
  • Patients with pT4 tumors.
  • Patients recommended to receive regional nodal irradiation with associated radiation risks

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: WBI-SIB

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

Interventions

Breast Radiotherapy

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Chasity McCue

919-966-4432chasity_mccue@med.unc.edu

Cory Grreenwood

919-445-4929cory_greenwood@med.unc.edu

Locations

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Claire Kowalczyk

919-966-4432claire_kowalczyk@med.unc.edu

Chasity McCue

chasity_mccue@med.unc.edu

Principal Investigator:

Ethan Steele, MD, MS

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Sep 3, 2026

Last verified

Mar, 2026

Keywords

  • whole breast irradiation
  • WBI
  • simultaneous integrated tumor bed boost (SIB)
  • SIB
  • Concurrent boost
  • adverse effects
  • toxicity
  • Radiation-specific toxicity
  • patient reported outcome
  • PRO-CTCAE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-09-03.