Breast Cancer Recurrent
Conditions
Keywords
Ipsilateral
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.
Interventions
RADIATIONReirradiation
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.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-associated toxicity | Within 1 year | Acceptably low acute treatment-associated adverse events following breast re-irradiation with aPBI. |
Countries
United States
Outcome results
None listed