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

NCT06008158 | Active Not Recruiting Phase 2 DMC FDA Device

• 3 other identifiers: 23037NCI-2023-05718P30CA033572
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Estrogen Receptor-Positive Breast Carcinoma; HER2-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  Measured by the 4-point Global Cosmetic Score (GCS). The exact test will be used to test the hypothesis that the rate of cosmesis is \>= 90% versus the null hypothesis that cosmesis is 74% or lower, at the 5% significance level.

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

Secondary Outcomes (10)

• Cosmetic outcome by the patient post-APBI QD

  Over time at baseline, day 5, 1 month, 6 months, 1 year, 2 years and 3 years

• Cosmetic outcome assessed by the physician post-APBI QD

  At 1 year

• Cosmetic outcome assessed by the physician post-APBI QD

  Over time at baseline, day 5, 1 month, 6 months 1 year, 2 years and 3 years

• Incidence of adverse events-patients reported

  Up to 3 years post-APBI

• Incidence of adverse events-treatment team reported

  Up to 3 years post-APBI

Study Arms (1)

Supportive care (APBI)

EXPERIMENTAL

Patients undergo APBI QD on consecutive business days for 5 treatments.

Radiation: Accelerated Partial Breast Irradiation

Interventions

Accelerated Partial Breast Irradiation RADIATION

Undergo APBI

Also known as: Accelerated Partial Breast Radiation Therapy, APBI

Supportive care (APBI)

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 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

You may not qualify if:

• Any prior treatment with radiation therapy, anti-endocrine/hormone therapy, chemotherapy or biologic therapy for the currently diagnosed breast cancer PRIOR to surgical resection
• Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude partial breast irradiation
• Clinically significant uncontrolled illness
• 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 (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jose G Bazan

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Cosmetic outcome assessed by blinded medical doctor review.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 23, 2023
• Study Start: September 29, 2023
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)