Active — Not RecruitingPhase 2

Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Pts w/Low Risk, Hormone Responsive Brst Ca

United States48 participantsStarted 2023-09-29

Plain-language summary

This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells in a smaller area of the breast (partial breast) instead of the whole breast or chest area as in standard therapy. Additionally, APBI is given in a shorter course of treatment than whole breast radiation therapy, over fewer days instead of several weeks, with a lower total dose of radiation. APBI is currently given every other business day for a total of 5 treatments with excellent results; however, a shorter treatment duration could have similar or even better results. Undergoing APBI every day on consecutive business days for 5 treatments may result in an improved breast appearance for patients with low risk hormone responsive breast cancer.

Who can participate

Age range40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Age: \>= 40 years * Female * Ability to read and understand English or Spanish for questionnaires * Anatomic pathologic stage 0 (ductal carcinoma in situ \[DCIS\]) or stage IA (invasive) breast cancer * Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed * Tissue from core biopsy or resection must show hormone sensitive receptors. Hormone sensitive receptors are defined as the following: * \- DCIS: Estrogen receptor (ER) positive (\>= 60%) * Invasive breast cancer: * Oncotype DX =\< 25 (if performed) OR * If Oncotype DX is not performed an Allred score of 7 or 8. The following combinations of proportion of ER positive cells and staining intensity are allowed: * ER positive (34-66% of cells) and staining intensity is strong (Allred 7) * ER positive (\>= 67% of cells) and staining intensity is intermediate (Allred 7) * ER positive (\>= 67% of cells) and staining intensity is strong (Allred 8) * Tissue from core biopsy or resection must be HER2 negative by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines * Patients must have undergone breast conserving surgery with resulting negative surgical margins (no tumor on ink). Re-excision for negative margins is allowed. Patients with pathologically involved surgical margins are excl…

What they're measuring

Proportion of women that rate the cosmetic appearance of the breast as acceptable ("excellent" or "good")

Timeframe: At 1 year post accelerated partial breast irradiation once daily (APBI QD)

Trial details

NCT IDNCT06008158

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-15