RECRUITING

Ultra-hypofractionated Whole Breast Irradiation With Lumpectomy Cavity Boost for the Treatment of Stage I-III Breast Cancer

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 clinical trial tests how well ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) works in treating patients with stage I-III breast cancer. Breast conservation therapy (BCT) is the recommended treatment for patients with early stage breast cancer. BCT involves a lumpectomy followed by breast radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Traditionally, WBI has been given once daily over 5-6 weeks and then those at high-risk for recurrence receive additional radiation (boost) to the lumpectomy cavity daily over 4-8 days. This has now been replaced by moderate hypofractionated radiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Although moderate hypofractionated radiation therapy reduces the length of treatment from 6-7 weeks to 3-4 weeks, the length of treatment still remains a barrier for many patients. UF-WBI with CB delivers radiation to the whole breast and the surgical cavity at the same time over 5 daily treatments. Giving UF-WBI with CB may prevent recurrence and prolong survival as well as improve the quality of life in patients with stage I-III breast cancer.

Official Title

Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost

Quick Facts

Study Start:2025-10-05
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06954831

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:40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent of the participant and/or legally authorized representative
  2. * Age: ≥ 40 years
  3. * Female
  4. * Ability to read and understand English for questionnaires
  5. * Histologically confirmed breast cancer
  6. * Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed
  7. * Patients must have undergone breast conserving surgery. Re-excision for negative margins is allowed
  8. * Patients must have undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection)
  9. * Must have at least one-high risk feature that would necessitate a lumpectomy cavity boost by the treating radiation oncologist
  10. * Patient must have physician-reported "Excellent" or "Good" cosmesis post-lumpectomy and prior to radiation therapy based on the 4-point Global Cosmetic Score
  11. * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
  12. * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  13. * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
  1. * Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude breast irradiation
  2. * Pathologically or clinically involved regional lymph nodes necessitating comprehensive regional nodal irradiation that includes the supraclavicular fossa
  3. * Clinically significant uncontrolled illness
  4. * Stage IV breast cancer
  5. * Diagnosis of Paget's disease of the nipple
  6. * Other prior or active malignancy. Patients 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
  7. * Pregnant or breastfeeding
  8. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Contacts and Locations

Principal Investigator

Stephanie M Yoon
PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center

Study Locations (Sites)

City of Hope at Arcadia
Arcadia, California, 91007
United States
City of Hope Medical Center
Duarte, California, 91010
United States
City of Hope at Irvine Lennar
Irvine, California, 92618
United States
City of Hope Antelope Valley
Lancaster, California, 93534
United States
City of Hope South Pasadena
South Pasadena, California, 91030
United States
City of Hope at South Bay
Torrance, California, 90503
United States
City of Hope Upland
Upland, California, 91786
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Stephanie M Yoon, PRINCIPAL_INVESTIGATOR, City of Hope 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 Date2025-10-05
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2025-10-05
Study Completion Date2028-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Breast Carcinoma