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Clinical Trial NCT06902311 (H-ASSIST) for Breast Cancer, Early-stage Breast Cancer, Ductal Carcinoma in Situ, DCIS is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST) Phase 2 90

Recruiting
Clinical Trial NCT06902311 (H-ASSIST) is designed to study Treatment for Breast Cancer, Early-stage Breast Cancer, Ductal Carcinoma in Situ, DCIS. It is a Phase 2 interventional study that is recruiting, having started on 19 February 2025, with plans to enroll 90 participants. Led by UNC Lineberger Comprehensive Cancer Center, it is expected to complete by 1 February 2028. The latest data from ClinicalTrials.gov was last updated on 30 March 2026.
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-...

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Detailed Description
Multiple recent studies demonstrate the noninferiority of a simultaneous integrated boost (SIB) approach. This study will include women aged 50 years and older who are recommended to receive whole breast irradiation with a standard dose boost and without regional nodal irradiation.

Radiation therapy will consist of 5 fractions delivered every other day (excluding weekends), with a total dose of 26 Gy to the whole br...

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Official Title

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

Conditions
Breast CancerEarly-stage Breast CancerDuctal Carcinoma in SituDCIS
Other Study IDs
  • H-ASSIST
  • LCCC2404
NCT ID Number
NCT06902311
Start Date (Actual)
2025-02-19
Last Update Posted
2026-03-30
Completion Date (Estimated)
2028-02
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
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
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalWBI-SIB
Five-fraction whole breast irradiation (WBI) with simultaneous integrated tumor bed boost (SIB).
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 Measures
Outcome MeasureMeasure DescriptionTime Frame
Rate of any moderate-marked adverse effects
The rate of moderate to marked adverse effects in the breast or chest wall at 1 year will be measured using a questionnaire called the Clinician Assessment of Radiation-Specific Toxicity by clinican. This will be compared against historical controls. The questionnaire includes 10 items: 4 Likert-type questions and 6 yes/no questions. Items are rated from 0 to 4, with higher scores indicating more adverse effects. A "yes" response indicates the occurrence of an adverse event.
1 year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
In-breast tumor recurrence
In-breast tumor recurrence at 2 years is defined according to the standard definition as the time from enrollment to any of the following events: invasive ipsilateral recurrence and/or ipsilateral DCIS recurrence. Recurrence will be measured via medical record abstraction and clinical evaluation.
2 years
Quality of life at measured by European Organization for Research and Treatment of Cancer ( EORTC QLQ-C30)
Quality of life at 12 months will be measured as defined by European Organization for Research and Treatment of Cancer ( EORTC QLQ-C30). The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.
12 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
Female
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
  • 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.

  • 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
UNC Lineberger Comprehensive Cancer Center logoUNC Lineberger Comprehensive Cancer Center
Study Central Contact
Contact: Jessica Buddenbaum, 919-966-4432, [email protected]
Contact: Cory Grreenwood, 919-445-4929, [email protected]
1 Study Locations in 1 Countries

North Carolina

University of North Carolina, Chapel Hill, North Carolina, 27599, United States
Jessica Buddenbaum, Contact, 919-966-4432, [email protected]
Dana Casey, MD, Principal Investigator
Recruiting