RightFit
Not yet recruitingPhase 1 / Phase 2

aPBI Re-irradiation

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests giving radiation again to only part of the breast, called aPBI, for people with a second cancer in the same breast. It checks early side effects, how well treatment keeps cancer from returning in that breast, and changes in how the breast looks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a second cancer in the same breast, confirmed by a tissue test, more than 1 year after finishing treatment that kept the breast.
  • Have had radiation to that breast before, and still have the affected breast.
  • Be age 40 or older and meet ASTRO 2023 guidelines: grade 1 or 2 cancer (lower or medium grade), cancer that uses estrogen to grow (ER-positive), and a tumor no larger than 2 cm.
  • Plan to get breast radiation at D-H Lebanon, D-H St. Johnsbury, or Cheshire Medical Center.
  • Have an area where the lump was removed that can be clearly outlined on a CT scan.
  • Be able to understand the study and give consent to join.
  • If able to become pregnant, have a negative urine or blood pregnancy test within 14 days before joining.
  • If able to become pregnant, not be pregnant or breastfeeding, and agree to use medically accepted birth control during radiation.

Who can't join

  • Have not had radiation to the affected breast before.
  • Be younger than 40 or not meet the ASTRO 2023 guidelines for a strong recommendation for radiation to part of the breast.
  • Have breast implants or another type of breast rebuilding surgery.
  • Have had aPBI or radiation placed inside the affected breast (brachytherapy) before.
  • Be getting treatment for another cancer now or have had it within the past year, except for non-melanoma skin cancer.
  • Be pregnant.
  • Be unable to give consent or choose not to join.
  • Have active lupus, any history of scleroderma, or dermatomyositis with an active rash. These are immune system diseases that can affect the skin or other body parts.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

NH