Recruiting
Phase 2

UF-WBI with CB

Sponsor:

City of Hope Medical Center

Code:

NCT06954831

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Cone-Beam Computed Tomography

Hypofractionated External Beam Radiation Therapy

Questionnaire Administration

Radiation Boost

Whole Breast Irradiation

Study Details

Brief summary:

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 This has now been replaced by moderate hypofractionated radiation.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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Breast Carcinoma

Study ID

NCT06954831

Start date

Aug 28, 2025

Status verified date

Oct, 2025

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Documented informed consent of the participant and/or legally authorized representative
  • Age: ≥ 40 years
  • Female
  • Ability to read and understand English for questionnaires
  • Histologically confirmed breast cancer
  • Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed
  • Patients must have undergone breast conserving surgery. Re-excision for negative margins is allowed
  • Patients must have undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection)
  • Must have at least one-high risk feature that would necessitate a lumpectomy cavity boost by the treating radiation oncologist
  • Patient must have physician-reported "Excellent" or "Good" cosmesis post-lumpectomy and prior to radiation therapy based on the 4-point Global Cosmetic Score
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test

  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Exclusion Criteria:

  • Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude breast irradiation
  • Pathologically or clinically involved regional lymph nodes necessitating comprehensive regional nodal irradiation that includes the supraclavicular fossa
  • Clinically significant uncontrolled illness
  • Stage IV breast cancer
  • Diagnosis of Paget's disease of the nipple
  • 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
  • Pregnant or breastfeeding
  • 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)

Study Design

Enrollment

82 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (UF-WBI with CB)

Patients undergo UF-WBI with CB QD on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CBCT prior to each radiation treatment.

Interventions

Cone-Beam Computed Tomography

Undergo CBCT

Hypofractionated External Beam Radiation Therapy

Undergo UF-WBI with CB

Questionnaire Administration

Ancillary studies

Radiation Boost

Undergo UF-WBI with CB

Whole Breast Irradiation

Undergo UF-WBI with CB

Primary outcome measure

  • Response rate [ Time Frame: At 1 year ]

Central Contacts and Locations

Locations

City of Hope at Arcadia

Recruiting

Arcadia, California, United States, 91007

Contacts

Stephanie M. Yoon

626-873-5241styoon@coh.org

Principal Investigator:

Stephanie M. Yoon

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Stephanie M. Yoon

626-873-5241styoon@coh.org

Principal Investigator:

Stephanie M. Yoon

City of Hope Antelope Valley

Recruiting

Lancaster, California, United States, 93534

Contacts

Stephanie M. Yoon

626-873-5241styoon@coh.org

Principal Investigator:

Stephanie M. Yoon

City of Hope South Pasadena

Recruiting

South Pasadena, California, United States, 91030

Contacts

Stephanie M. Yoon

626-873-5241styoon@coh.org

Principal Investigator:

Stephanie M. Yoon

City of Hope at South Bay

Recruiting

Torrance, California, United States, 90503

Contacts

Stephanie Yoon, MD

626-359-8111styoon@coh.org

City of Hope Upland

Recruiting

Upland, California, United States, 91786

Contacts

Stephanie M. Yoon

626-873-5241styoon@coh.org

Principal Investigator:

Stephanie M. Yoon

More Information

Sponsor

City of Hope Medical Center

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-10-29.