Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen

NCT05591547 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: SH APBI RISE
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

Brief Summary

This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day for five treatments, over ten calendar days. The APBI in this study is modified and will deliver five once daily treatments over consecutive treatment days, with a slightly lower dose of radiation each day as compared to the standard external beam-based APBI treatment.

Conditions

Breast Cancer

Keywords

Invasive Ductal Carcinoma; Ductal Carcinoma In-Situ; Intensity Modulated Radiation Therapy; Volumetric Modulated Arc Therapy; Accelerated Partial Breast Irradiation; External Beam Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Physician-Assessed Adverse Breast Cosmesis

  To evaluate the incidence of physician-assessed adverse breast cosmesis by utilizing the Harvard Breast Cosmesis survey. The survey scores breast cosmesis from 1 to 4, with 1 representing "excellent" cosmesis, 2 representing "good" cosmesis, 3 representing "fair" cosmesis, and 4 representing "poor" cosmesis. Adverse breast cosmesis is defined as a score of either 3 or 4 on the Harvard Breast Cosmesis survey.

  2 Years

Secondary Outcomes (6)

• Recurrence Rate

  2 Years

• Disease Free Survival Rate

  2 Years

• Acute Adverse Events

  12 Weeks

• Late Adverse Events

  2 Years

• Patient Quality of Life

  2 Years

Study Arms (1)

IMRT/VMAT-Based Accelerated Partial Breast Irradiation

EXPERIMENTAL

Patients will be treated with a novel IMRT/VMAT-based accelerated partial breast irradiation regimen.

Radiation: IMRT/VMAT-Based Accelerated Partial Breast Irradiation

Interventions

IMRT/VMAT-Based Accelerated Partial Breast Irradiation RADIATION

The lumpectomy bed will receive a total of 26 Gy in 5 fractions, with 1 fraction delivered per day. Ideally, the course of radiation therapy would be completed over 5 consecutive treatment days. Treatment must begin within 12 weeks of lumpectomy or re-excision of surgical margins and must be completed within 10 calendar days.

IMRT/VMAT-Based Accelerated Partial Breast Irradiation

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed written consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3 or a Karnofsky performance score of ≥ 30%.
• Willingness to return to Sanford Cancer Center for follow-up.
• Radiation therapy is planned as part of routine care.
• On histological examination, the tumor must be either ductal carcinoma in-situ (DCIS) or an invasive ductal carcinoma of the breast.
• Patients must be ≥ 50 years old.
• Presence of unifocal tumor.
• Surgical treatment of the breast must have been a lumpectomy. Placement of surgical clips to delineate the lumpectomy bed is highly recommended, though not required.
• The final margins of the resected specimen must be histologically free of tumor (≥ 2 mm for invasive adenocarcinoma and ≥ 3 mm for DCIS). Re-excision of surgical margins is permitted. Gross disease must be unifocal with a pathologic invasive tumor size tumor size ≤ 2.0 cm or pathologic DCIS size ≤ 2.5 cm.
• Patients with invasive breast cancer are required to have axillary staging consisting of a sentinel lymph node biopsy. The sentinel lymph node(s) must be negative for regionally metastatic disease, both on routine H\&E evaluation and immunohistochemical staining. Axillary staging is not required for patients with DCIS.
• Absence of lymphovascular space invasion.
• The tumor must be positive for either the presence of the estrogen or progesterone receptor, and either 0 or +1 for the HER-2/neu receptor on immunohistochemical staining.
• The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity to the whole breast reference volume ratio must be ≤ 30% based on the CT-simulation scan.
• Life expectancy of 5 years or longer excluding breast cancer diagnosis(co-morbid conditions taken into considerations by the PI)
• Women of child-bearing potential must have a negative pregnancy test before their CT simulation, and must agree to use an effective method of birth control during their radiation therapy treatment course.

You may not qualify if:

• Pregnant women, or women of childbearing potential who are unwilling to employ adequate contraception.
• Nuclear grade 3 DCIS or Nottingham grade 3 invasive ductal carcinoma.
• Invasive lobular carcinoma, any grade.
• Male sex.
• Any treatment with radiation therapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to study enrollment
• Prior breast or thoracic radiation treatment for any reason.
• History of prior invasive breast cancer or DCIS. (Patients with a history of LCIS treated by surgery alone are eligible.)
• Paget's disease of the nipple.
• Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
• Patients with a collagen vascular disease; specifically, SLE or scleroderma.
• Breast implants. (Patients who have had implants removed are eligible.)
• Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
• Women with a known or suspected predisposition to developing breast cancer (i.e., BRCA1/2 mutations, p53 mutation, etc...)
• Women who are pregnant, or women of child-bearing potential who refuse to use an effective method of birth control

Sponsors & Collaborators

• Sanford Health: lead
• University of North Dakota: collaborator

Study Sites (2)

Sanford Health

Worthington, Minnesota, 56187, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

Related Publications (33)

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MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Ryan Nowak, MD

  Sanford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single group non-randomized interventional prospective cohort study

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 24, 2022
• Study Start: March 30, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)