aPBI Re-irradiation (REPEAT)

Dartmouth Health

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Breast Cancer Recurrent

Treatments: Radiation: Reirradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT07612254

25JAR817 (Other Identifier)

Study02002817

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

aPBI Re-irradiation

Experimental group

Description:

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.

Treatment:

Radiation: Reirradiation