Ultra‑short whole-breast radiation with lumpectomy cavity boost for stage I–III breast cancer
Official title: Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost
Run by City of Hope Medical Center · NCT06954831 · Data updated 2026-11-12
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 |
| Ages | 40 Years and up |
| Sex | Women only |
| Enrollment | 82 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Arcadia, California and 6 other locations) |
| Status | Recruiting |
| Started | August 28, 2025 |
| Main results expected | January 31, 2028 |
| Study ends | January 31, 2028 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT06954831 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
City of Hope at Arcadia
Arcadia, California, United States Recruiting -
City of Hope Medical Center
Duarte, California, United States 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
Show 1 more location
-
City of Hope at Irvine Lennar
Irvine, California, United States Not yet recruiting
Study contacts
- Principal investigator: Stephanie M Yoon — City of Hope Medical Center
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Blended e-Health Program to Help Women with Breast or Gynecologic Cancer Manage Fear of Cancer Progression
This trial tests a blended online and group program to see if it helps women with breast or gynecologic cancer feel less fear that their cancer could grow or spread.
-
Personalized Exercise Plan for Breast Cancer Survivors on Chemotherapy
This trial tests whether adding a guided exercise program to a healthy-lifestyle education plan helps breast cancer patients undergoing chemotherapy maintain fitness, heart health, and quality of life.
-
Sleep Changes and Biomarkers After Breast Cancer Treatment
This project will see how sleep patterns and stress-related biological markers change from treatment through survivorship in people with stage I–III hormone receptor–positive breast cancer.
-
Hypofractionated radiotherapy for non-metastatic breast cancer treatment
This study is testing if giving a shorter course of radiation therapy before or after surgery can help women with non-metastatic breast cancer while causing fewer severe side effects.
-
Navigation program to boost survivorship support participation for non-metastatic breast cancer survivors
This program tests whether a patient navigation service helps non-metastatic breast cancer survivors use survivorship support services more often.
-
Goserelin Injections: Is Upper-Gluteal Dosing as Good as Abdominal Dosing for OFS in Localized and Locally Advanced HR+ Breast Cancer
This phase 2 trial tests whether giving goserelin acetate injections in the upper gluteal region works as well as abdominal injections for suppressing ovarian function in premenopausal women with localized or locally advanced hormone receptor–positive breast cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.