RECRUITING

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

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Conditions

Breast CancerEarly-stage Breast CancerDuctal Carcinoma in SituDCISwhole breast irradiationWBIsimultaneous integrated tumor bed boost (SIB)SIBConcurrent boostadverse effectstoxicityRadiation-specific toxicitypatient reported outcomePRO-CTCAE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-12
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06902311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  2. * Women ≥ 50 years of age with confirmed de novo invasive carcinoma of breast or ductal carcinoma in situ.
  3. * Subjects with completed breast-conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
  4. * 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.
  5. * 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.
  6. * Enrollment in another clinical trial is allowed if there is no interference with interventions on this trial per discretion of the Principal Investigator.
  1. * Receipt of concurrent breast reduction involving tissue rearrangement in the lumpectomy cavity (so that boost cannot be accurately targeted).
  2. * Synchronous bilateral breast cancer requiring bilateral radiation therapy.
  3. * Clinical or imaging evidence of distant metastases.
  4. * Prior ipsilateral breast or thoracic radiation.
  5. * Autoimmune conditions
  6. * Collagen Vascular Disease (such as systemic lupus erythematosus, scleroderma, dermatomyositis, among others)
  7. * Patients with pT4 tumors.
  8. * Patients recommended to receive regional nodal irradiation with associated radiation risks

Contacts and Locations

Study Contact

Jessica Buddenbaum
CONTACT
919-966-4432
jessica_buddenbaum@med.unc.edu
Cory Grreenwood
CONTACT
919-445-4929
cory_greenwood@med.unc.edu

Principal Investigator

Dana Casey, MD
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

University of North Carolina
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Dana Casey, MD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-12
Study Completion Date2028-02

Study Record Updates

Study Start Date2025-03-12
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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