NCT06954831 · City of Hope Medical Center
Ultra-hypofractionated Whole Breast Irradiation With Lumpectomy Cavity Boost for the Treatment of Stage I-III Breast Cancer
What this study is about
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.
View original scientific 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.
Interventions
PROCEDURE
Cone-Beam Computed Tomography
Undergo CBCT
RADIATION
Hypofractionated External Beam Radiation Therapy
Undergo UF-WBI with CB
OTHER
Questionnaire Administration
Ancillary studies
RADIATION
Radiation Boost
Undergo UF-WBI with CB
RADIATION
Whole Breast Irradiation
Undergo UF-WBI with CB
Primary outcome measures
Response rate
Time frame: At 1 year
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Documented informed consent of the participant and/or legally authorized representative
- Age: ≥ 40 years
- 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 con
Where
- Arcadia, California
- Duarte, California
- Irvine, California
- Lancaster, California
- South Pasadena, California
- Torrance, California
- Upland, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations