RECRUITING

Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\<13% grade \>3 toxicity).

Official Title

Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)

Quick Facts

Study Start:2023-06-27
Study Completion:2027-06-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05592938

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years
  2. * In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma)
  3. * Tumour \<3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components
  4. * \>5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted)
  5. * Clinically node negative
  6. * Negative margins (no tumour on ink)
  7. * Recovered from surgery with the incision completely healed and no signs of infection
  1. * Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)
  2. * Tumour histology limited to lobular carcinoma only
  3. * Extensive intraductal component
  4. * T4 disease
  5. * Node positive or distant metastatic disease
  6. * Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment
  7. * Currently pregnant or lactating
  8. * Presence of an ipsilateral breast implant or pacemaker
  9. * Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy
  10. * Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips).
  11. * Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol
  12. * Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0

Contacts and Locations

Study Contact

Danielle Rodin, MD
CONTACT
(416) 946-6513
danielle.rodin@uhn.ca
Anne Koch, MD
CONTACT
(416) 946-2919
anne.koch@uhn.ca

Principal Investigator

Danielle Rodin, MD
PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre
Anne Koch, MD
PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: University Health Network, Toronto

  • Danielle Rodin, MD, PRINCIPAL_INVESTIGATOR, Princess Margaret Cancer Centre
  • Anne Koch, MD, PRINCIPAL_INVESTIGATOR, Princess Margaret Cancer Centre

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-27
Study Completion Date2027-06-27

Study Record Updates

Study Start Date2023-06-27
Study Completion Date2027-06-27

Terms related to this study

Keywords Provided by Researchers

  • Hypofractionated

Additional Relevant MeSH Terms

  • Breast Cancer
  • Breast Cancer Recurrent