Ultra‑short whole-breast radiation with lumpectomy cavity boost for stage I–III breast cancer
Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost
This trial will test whether a very short course of whole‑breast radiation with a boost to the lumpectomy cavity works well and is safe for women age 40 and older with stage I–III breast cancer who had breast‑conserving surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Arcadia, California and 6 other locations) |
| Trial ID | NCT06954831 on ClinicalTrials.gov |
What this trial studies
Patients who had lumpectomy and surgical axillary staging receive ultra‑hypofractionated whole breast irradiation with a lumpectomy cavity boost delivered once daily for up to five fractions, with cone‑beam CT before each treatment. The primary outcome is patient‑reported global cosmesis at one year, and physicians will also report acute and late toxicities and cosmesis over time. Exploratory analyses will examine quality of life and dosimetric/volumetric factors tied to cosmetic outcomes and toxicity. Follow‑up visits occur at 1 month, 6 months, then annually for up to five years to capture recurrence and survival endpoints.
Who should consider this trial
Good fit: Women aged 40 or older with histologically confirmed epithelial stage I–III breast cancer who had breast‑conserving surgery, axillary staging, at least one physician‑determined high‑risk feature warranting a boost, and good baseline cosmesis are ideal candidates.
Not a fit: Patients with non‑epithelial breast malignancies, those who require mastectomy, have poor baseline cosmesis, cannot undergo daily radiation/CBCT, are pregnant, or otherwise medically ineligible are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could substantially shorten the radiation schedule while preserving breast appearance and keeping side effects low.
How similar studies have performed: Moderate hypofractionated whole‑breast radiation has broad evidence of safety and efficacy, but ultra‑hypofractionated whole‑breast schedules with a lumpectomy cavity boost are relatively novel and supported mainly by early or limited data.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Arcadia, California and 6 other locations
- City of Hope at Arcadia — Arcadia, California, United States (Recruiting)
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
- City of Hope at Irvine Lennar — Irvine, California, United States (Not_yet_recruiting)
- City of Hope Antelope Valley — Lancaster, California, United States (Recruiting)
- City of Hope South Pasadena — South Pasadena, California, United States (Recruiting)
- City of Hope at South Bay — Torrance, California, United States (Recruiting)
- City of Hope Upland — Upland, California, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie M Yoon — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.