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

NCT06954831 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 23860NCI-2025-02185P30CA033572
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 7

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 This has now been replaced by moderate hypofractionated radiation.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

Outcome Measures

Primary Outcomes (1)

• Response rate

  Responding patients are defined as patients with a rating of either "excellent" or "good" on the 4-point Global Cosmesis Score (GCS). Will be estimated along with the 95% exact binomial confidence interval.

  At 1 year

Secondary Outcomes (12)

• Patient-reported cosmetic outcome using GCS - Baseline

  At baseline

• Patient-reported cosmetic outcome using GCS - 6 months

  At 6 months

• Patient-reported cosmetic outcome using GCS - 1 year

  At 1 year

• Patient-reported cosmetic outcome using GCS - 2 years

  At 2 years

• Patient-reported cosmetic outcome using GCS - 3 years

  At 3 years

Study Arms (1)

Treatment (UF-WBI with CB)

EXPERIMENTAL

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.

Procedure: Cone-Beam Computed Tomography; Radiation: Hypofractionated External Beam Radiation Therapy; Other: Questionnaire Administration; Radiation: Radiation Boost; Radiation: Whole Breast Irradiation

Interventions

Cone-Beam Computed Tomography PROCEDURE

Undergo CBCT

Also known as: Cone Beam Computed Tomography, Cone Beam CT

Treatment (UF-WBI with CB)

Hypofractionated External Beam Radiation Therapy RADIATION

Undergo UF-WBI with CB

Treatment (UF-WBI with CB)

Questionnaire Administration OTHER

Ancillary studies

Treatment (UF-WBI with CB)

Radiation Boost RADIATION

Undergo UF-WBI with CB

Also known as: BOOST, Boost Radiation, Boost Radiation Therapy, Boost Radiotherapy, Radiation Therapy Boost, Radiotherapy Boost

Treatment (UF-WBI with CB)

Whole Breast Irradiation RADIATION

Undergo UF-WBI with CB

Treatment (UF-WBI with CB)

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

City of Hope at Arcadia

Arcadia, California, 91007, United States

RECRUITING

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

NOT YET RECRUITING

City of Hope Antelope Valley

Lancaster, California, 93534, United States

RECRUITING

City of Hope South Pasadena

South Pasadena, California, 91030, United States

RECRUITING

City of Hope at South Bay

Torrance, California, 90503, United States

RECRUITING

City of Hope Upland

Upland, California, 91786, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stephanie M Yoon

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 2, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (7)