aPBI Re-irradiation (REPEAT)

REPEAT: RE-irradiation With a Partial brEast, Accelerated Technique: A Single-Center, Multi-site, Prospective, Phase I/II Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Recurrent
• Intervention / Treatment: Radiation: Reirradiation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Patients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy.
2. Patients must have received prior radiotherapy to the breast
3. Patients must have an intact, involved breast.

4. 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
5. Patients who will undergo breast radiation therapy at D-H Lebanon, D-H St. Johnsbury, or Cheshire Medical Center.
6. Patients must have a lumpectomy cavity that can be delineated on CT scan.
7. Patients who are able to provide informed consent.
8. Females of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry.
9. Females of childbearing potential must not be pregnant and not lactating and willing to use medically acceptable form of contraception during radiation therapy.

Exclusion Criteria

Patients who meet any of the criteria below may NOT participate in this study:

1. Patients who have not received prior radiotherapy to the ipsilateral breast.
2. 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.
3. Patients who are < 40 years of age.
4. Patients with breast implants or other breast reconstruction.
5. Patients who received a prior course of aPBI or breast brachytherapy in the ipsilateral breast.
6. Patients who are actively receiving treatment or within 1 year of treatment from another malignancy, excluding non-melanoma skin cancers.
7. Patients who are pregnant.
8. Patients who are unable to provide informed consent.
9. Patients who decline participation in the study.
10. Patients with active systemic lupus erythematosus, or any history of scleroderma, dermatomyositis with active rash are excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aPBI Re-irradiation; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-associated toxicity	Acceptably low acute treatment-associated adverse events following breast re-irradiation with aPBI.	Within 1 year

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 3, 2026
• Primary Completion (Estimated): April 28, 2032
• Study Completion (Estimated): April 1, 2033

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Ipsilateral
• Additional Relevant MeSH Terms: Therapeutics; Radiotherapy; Retreatment; Re-Irradiation
• Other Study ID Numbers: Study02002817; 25JAR817 (Other Identifier: DH Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No