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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Breast Radiotherapy

Treatment groups

90 Participants
are divided into 1 treatment group