aPBI Re-irradiation

NCT07612254 | Not Yet Recruiting Phase 1 DMC FDA Device

• 2 other identifiers: Study0200281725JAR817
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine whether acute treatment-associated adverse events following breast re-irradiation with aPBI are acceptably low and to assess local control following breast re-irradiation with aPBI. An exploratory aim is to assess cosmetic outcomes following breast re-irradiation with aPBI.

Conditions

Breast Cancer Recurrent

Keywords

Ipsilateral

Outcome Measures

Primary Outcomes (1)

• Treatment-associated toxicity

  Acceptably low acute treatment-associated adverse events following breast re-irradiation with aPBI.

  Within 1 year

Study Arms (1)

aPBI Re-irradiation

EXPERIMENTAL

Patients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy and have received or are receiving re-irradiation for in-breast recurrence of breast cancer.

Radiation: Reirradiation

Interventions

Reirradiation RADIATION

aPBI, which is routinely used to treat patients who have previously not been irradiated, with a dose of 30 Gy in 5 fractions using a VMAT technique.

aPBI Re-irradiation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy.
• Patients must have received prior radiotherapy to the breast
• Patients must have an intact, involved breast.
• Patients must meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation.
• Grade 1-2 disease
• ER-positive histology
• Tumor size up to 2 cm
• Patient's age 40 or older
• Patients who will undergo breast radiation therapy at D-H Lebanon, D-H St. Johnsbury, or Cheshire Medical Center.
• Patients must have a lumpectomy cavity that can be delineated on CT scan.
• Patients who are able to provide informed consent.
• Females of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry.
• Females of childbearing potential must not be pregnant and not lactating and willing to use medically acceptable form of contraception during radiation therapy.

You may not qualify if:

• Patients who meet any of the criteria below may NOT participate in this study:
• Patients who have not received prior radiotherapy to the ipsilateral breast.
• Patients who do not meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation, including those who meet criteria for conditionally recommended, conditionally not recommended, and not recommended for partial breast irradiation.
• Patients who are \< 40 years of age.
• Patients with breast implants or other breast reconstruction.
• Patients who received a prior course of aPBI or breast brachytherapy in the ipsilateral breast.
• Patients who are actively receiving treatment or within 1 year of treatment from another malignancy, excluding non-melanoma skin cancers.
• Patients who are pregnant.
• Patients who are unable to provide informed consent.
• Patients who decline participation in the study.
• Patients with active systemic lupus erythematosus, or any history of scleroderma, dermatomyositis with active rash are excluded.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Interventions

Re-Irradiation

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Retreatment

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Radiation Oncology

Model Details: This is a prospective, single-arm, phase I/II clinical trial. The study will be conducted in two stages. We plan to enroll the first 11 participants into the phase 1 portion of the trial and follow them for toxicities for 1 year. Once toxicity assessment is complete and safety is determined, an additional 22 participants

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 28, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): April 28, 2032
• Study Completion (Estimated): April 1, 2033
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

US (1)