Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

Last updated: February 4, 2025
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

rPBI

Clinical Study ID

NCT05592938
22-5074
  • Ages 18-99
  • All Genders

Study 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 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years

  • In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasivecarcinoma)

  • Tumour <3.0 cm in greatest diameter on pathologic examination, including bothinvasive and non-invasive components

  • >5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted)

  • Clinically node negative

  • Negative margins (no tumour on ink)

  • Recovered from surgery with the incision completely healed and no signs of infection

Exclusion

Exclusion Criteria:

  • Multicentric disease (patients with multifocal breast cancer in the same quadrantare eligible)

  • Tumour histology limited to lobular carcinoma only

  • Extensive intraductal component

  • T4 disease

  • Node positive or distant metastatic disease

  • Serious non-malignant disease (cardiovascular, pulmonary, systemic lupuserythematosus, 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 lastsurgical procedure on the breast) or within 12 weeks from last cycle of adjuvantchemotherapy

  • Unable to clearly define the surgical cavity (oncoplastic procedures are permittedprovided the tumor bed is well delineated with surgical clips).

  • Psychiatric disorders which would preclude obtaining informed consent or adherenceto protocol

  • Grade II or more late skin toxicity from prior radiation evaluated and graded usingCTCAE v5.0

Study Design

Total Participants: 171
Treatment Group(s): 1
Primary Treatment: rPBI
Phase:
Study Start date:
June 27, 2023
Estimated Completion Date:
June 27, 2027

Study Description

Most women affected by breast cancer are treated with breast-conserving surgery to remove the tumour, followed by radiation to reduce the risk of recurrence. Unfortunately, some women will experience recurrence of the cancer in the previously treated breast. These recurrences have historically been treated by removing the whole breast or a second breast-conserving surgery followed by 3 to 5 weeks of radiation. These treatments can negatively impact mental health and quality of life or lead to harmful side effects that could impact the skin, breast, ribs, heart and lungs.

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).

The target population for this study is women with localized recurrent or new primary breast cancer in the previously irradiated breast. This is a prospective single arm phase 2 trial of external beam rPBI using 26Gy in 5 fractions delivered daily over 1-week after a second lumpectomy for LR following prior BCS and adjuvant whole or partial breast irradiation. Using a multi-institutional and international network of comprehensive cancer centers, this study will advance global knowledge of how to optimally treat women with this disease.

Connect with a study center

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • A.C.Camargo Cancer Center

    São Paulo, SP 105401
    Brazil

    Active - Recruiting

  • Odette Cancer Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G2C4
    Canada

    Active - Recruiting

  • CHU de Québec-Université Laval

    Montreal, Quebec G1G 5X1
    Canada

    Active - Recruiting

  • Centre hospitalier de l'Université de Montréal

    Montreal, Quebec H2X 3E4
    Canada

    Active - Recruiting

  • Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal

    Montreal, Quebec H1T 2M4
    Canada

    Active - Recruiting

  • King Hussein Cancer Centre

    Amman,
    Jordan

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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