Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

NCT05592938 | Recruiting

• 1 other identifier: 22-5074
• Study Type: interventional
• Target: 171
• Locations: 7 countries
• Sites: 15

Brief 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).

Conditions

Breast Cancer; Breast Cancer Recurrent

Keywords

Hypofractionated

Outcome Measures

Primary Outcomes (1)

• Grade ≥3 toxicity associated with treatment

  TThe primary endpoint, grade ≥3 toxicity associated with treatment will be summarized using frequency and percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.

  During accrual period, up to 3 years

Secondary Outcomes (15)

• Frequency radiation-associated toxicity (acute)

  3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI

• Percentage radiation-associated toxicity (acute)

  3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI

• Frequency radiation-associated toxicity (late)

  3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI

• Percentage radiation-associated toxicity (late)

  3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI

• Risk of local recurrence (invasive and DCIS)

  3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI

Study Arms (1)

rPBI

EXPERIMENTAL

26Gy in 5 daily fractions over 1-week

Radiation: rPBI

Interventions

rPBI RADIATION

External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week

rPBI

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• In-breast recurrence or new primary (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 (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

You may not qualify if:

• Multicentric disease (patients with multifocal breast cancer in the same quadrant are 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 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• Royal Victoria Regional Health Centre: collaborator
• AC Camargo Cancer Center: collaborator
• King Hussein Cancer Center: collaborator
• Tata Memorial Hospital: collaborator
• NYU Langone Health: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• Peter MacCallum Cancer Centre, Australia: collaborator
• CHU de Quebec-Universite Laval: collaborator
• l'Hopital Maisonneuve-Rosemont: collaborator
• L'Institut de recherche du Centre universitaire de sante McGill: collaborator
• Florence University Hospital: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator
• Virginia Commonwealth University: collaborator

Study Sites (15)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Virgina Community University Massey Comprehensive Cancer Center

Richmond, Virginia, 23298-0037, United States

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

A.C.Camargo Cancer Center

São Paulo, São Paulo, 105401, Brazil

RECRUITING

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

RECRUITING

Verspeeten Family Cancer Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2C4, Canada

RECRUITING

CHU de Québec-Université Laval

Montreal, Quebec, G1G 5X1, Canada

RECRUITING

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

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Tel-Aviv Sourasky Medical Centre

Tel Aviv, Israel

RECRUITING

Florence University Hospital

Florence, Italy

RECRUITING

King Hussein Cancer Centre

Amman, Jordan, Jordan

RECRUITING

Related Publications (12)

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  PMID: 29959283 BACKGROUND

• Arthur DW, Winter KA, Kuerer HM, Haffty B, Cuttino L, Todor DA, Anne PR, Anderson P, Woodward WA, McCormick B, Cheston S, Sahijdak WM, Canaday D, Brown DR, Currey A, Fisher CM, Jagsi R, Moughan J, White JR. Effectiveness of Breast-Conserving Surgery and 3-Dimensional Conformal Partial Breast Reirradiation for Recurrence of Breast Cancer in the Ipsilateral Breast: The NRG Oncology/RTOG 1014 Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320.

  PMID: 31750868 BACKGROUND

• Korzets Y, Lee G, Espin-Garcia O, Purdie T, Koch AC, Hodgson D, Barry A, Fyles A. The Role of Partial Breast Radiation in the Previously Radiated Breast. Am J Clin Oncol. 2019 Dec;42(12):932-936. doi: 10.1097/COC.0000000000000584.

  PMID: 31436745 BACKGROUND

• Brunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.

  PMID: 32663119 BACKGROUND

• Murray Brunt A, Haviland JS, Wheatley DA, Sydenham MA, Alhasso A, Bloomfield DJ, Chan C, Churn M, Cleator S, Coles CE, Goodman A, Harnett A, Hopwood P, Kirby AM, Kirwan CC, Morris C, Nabi Z, Sawyer E, Somaiah N, Stones L, Syndikus I, Bliss JM, Yarnold JR; FAST-Forward Trial Management Group. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. 2020 May 23;395(10237):1613-1626. doi: 10.1016/S0140-6736(20)30932-6. Epub 2020 Apr 28.

  PMID: 32580883 BACKGROUND

• Barrios CH, Reinert T, Werutsky G. Global Breast Cancer Research: Moving Forward. Am Soc Clin Oncol Educ Book. 2018 May 23;38:441-450. doi: 10.1200/EDBK_209183.

  PMID: 30231347 BACKGROUND

• Abdel-Razeq H, Mansour A, Jaddan D. Breast Cancer Care in Jordan. JCO Glob Oncol. 2020 Feb;6:260-268. doi: 10.1200/JGO.19.00279.

  PMID: 32083950 BACKGROUND

• Khader J, Glicksman RM, Mheid S, Mansour A, Giuliani ME, Gospodarowicz M, Almousa A, Abdel-Razeq H, Rodin D. Enhancing International Cancer Organization Collaborations: King Hussein Cancer Center and Princess Margaret Cancer Centre Model for Collaboration. J Cancer Educ. 2022 Jun;37(3):763-769. doi: 10.1007/s13187-020-01878-z. Epub 2020 Sep 14.

  PMID: 32926325 BACKGROUND

• Rodin D, Tawk B, Mohamad O, Grover S, Moraes FY, Yap ML, Zubizarreta E, Lievens Y. Hypofractionated radiotherapy in the real-world setting: An international ESTRO-GIRO survey. Radiother Oncol. 2021 Apr;157:32-39. doi: 10.1016/j.radonc.2021.01.003. Epub 2021 Jan 14.

  PMID: 33453312 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Danielle Rodin, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

• Anne Koch, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Rodin, MD

CONTACT

(416) 946-6513; danielle.rodin@uhn.ca

Anne Koch, MD

CONTACT

(416) 946-2919; anne.koch@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 25, 2022
• Study Start: June 27, 2023
• Primary Completion (Estimated): June 27, 2027
• Study Completion (Estimated): June 27, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); BR (1); IL (1); US (3); IT (1); JO (1); CA (7)