Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

Trial Title: Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

NCT ID: NCT05592938

Condition: Breast Cancer
Breast Cancer Recurrent

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Hypofractionated

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: rPBI
Description: External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week
Arm group label: rPBI

Summary: 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 they can accrue sufficient patient with rPBI who will be treated using 26 Gray(Gy) in 5 daily fractions over 1-week. Planned interim analysis after the 15 recruited patients for early toxicity evaluation with stopping rule for unacceptable toxicity.

Detailed description: Breast cancer is the leading cause of cancer in women worldwide, with over 2 million cases diagnosed every year. Although advances in treatment have led to an overall reduction in breast cancer mortality, survivors continue to have an ongoing risk of disease recurrence. For women who experience breast recurrence, mastectomy has historically been the only treatment approach offered. However, it has been associated with negative health outcomes, including reduced quality of life, depression and anxiety, and impaired sexual functioning. Fear of mastectomy has also been associated with delays in seeking appropriate and timely management of disease. As a result, there is increasing interest to identify treatment options that include breast preservation. 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. However, previously published studies have used long fractionation regimens for rPBI delivered over 3 to 5 weeks, which can present a challenge for both patients and health systems. This is particularly true in low- and middle-income countries, where more than half of new breast cancer cases now occur. 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 they can accrue sufficient patient with rPBI who will be treated using 26Gy in 5 daily fractions over 1-week. Planned interim analysis after the 15 recruited patients for early toxicity evaluation with stopping rule for unacceptable toxicity. Using an international network of comprehensive cancer centers, this study will advance global knowledge of how to optimally treat woman with this disease.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age > 18 years - In-breast recurrence (ductal carcinoma in situ (DCIS) or invasive carcinoma) - Tumour <3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components - >5 years after completion of prior adjuvant whole or partial breast radiotherapy - Clinically node negative - Negative margins (no tumour on ink) - Recovered from surgery with the incision completely healed and no signs of infection Exclusion Criteria: - Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible) - Extensive intraductal component - T4 disease - Node positive or distant metastatic disease - Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment - Currently pregnant or lactating - Presence of an ipsilateral breast implant or pacemaker - 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 - Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips). - Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol - Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Princess Margaret Cancer Centre

Address:
City: Toronto
Zip: M5G2C4
Country: Canada

Status: Recruiting

Contact:
Last name: Danielle Rodin, MD
Email: danielle.rodin@uhn.ca

Start date: June 27, 2023

Completion date: June 27, 2027

Lead sponsor:
Agency: University Health Network, Toronto
Agency class: Other

Collaborator:
Agency: Sunnybrook Health Sciences Centre
Agency class: Other

Collaborator:
Agency: Royal Victoria Regional Health Centre
Agency class: Other

Collaborator:
Agency: AC Camargo Cancer Center
Agency class: Other

Collaborator:
Agency: King Hussein Cancer Center
Agency class: Other

Collaborator:
Agency: Tata Memorial Hospital
Agency class: Other

Collaborator:
Agency: NYU Langone Health
Agency class: Other

Collaborator:
Agency: Centre hospitalier de l'Université de Montréal (CHUM)
Agency class: Other

Collaborator:
Agency: Peter MacCallum Cancer Centre, Australia
Agency class: Other

Collaborator:
Agency: CHU de Quebec (Université Laval)
Agency class: Other

Collaborator:
Agency: l'Hopital Maisonneuve-Rosemont
Agency class: Other

Collaborator:
Agency: L'Institut de recherche du Centre universitaire de sante McGill
Agency class: Other

Source: University Health Network, Toronto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05592938