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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05592938




Registration number
NCT05592938
Ethics application status
Date submitted
14/10/2022
Date registered
25/10/2022

Titles & IDs
Public title
Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
Scientific title
Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)
Secondary ID [1] 0 0
22-5074
Universal Trial Number (UTN)
Trial acronym
PRESERVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Breast Cancer Recurrent 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - rPBI

Experimental: rPBI - 26Gy in 5 daily fractions over 1-week


Treatment: Other: rPBI
External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Grade =3 toxicity associated with treatment
Timepoint [1] 0 0
During accrual period, up to 3 years
Secondary outcome [1] 0 0
Frequency radiation-associated toxicity (acute)
Timepoint [1] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [2] 0 0
Percentage radiation-associated toxicity (acute)
Timepoint [2] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [3] 0 0
Frequency radiation-associated toxicity (late)
Timepoint [3] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [4] 0 0
Percentage radiation-associated toxicity (late)
Timepoint [4] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [5] 0 0
Risk of local recurrence (invasive and DCIS)
Timepoint [5] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [6] 0 0
Risk of distant recurrence (invasive and DCIS)
Timepoint [6] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [7] 0 0
Location of local recurrence (in-field) (frequency)
Timepoint [7] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [8] 0 0
Location of local recurrence (in-field) (percentage)
Timepoint [8] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [9] 0 0
Location of local recurrence (out-of-field) (frequency)
Timepoint [9] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [10] 0 0
Location of local recurrence (out-of-field) (percentage)
Timepoint [10] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [11] 0 0
Risk of local recurrence after rPBI requiring mastectomy
Timepoint [11] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [12] 0 0
Invasive breast cancer free survival
Timepoint [12] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [13] 0 0
Overall survival
Timepoint [13] 0 0
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Secondary outcome [14] 0 0
Satisfaction with breasts
Timepoint [14] 0 0
Baseline, 1 year, 3 years, and 5 years post rPBI
Secondary outcome [15] 0 0
Financial toxicity associated with treatment
Timepoint [15] 0 0
Baseline, 3 months, 1 year, and 3 years post rPBI

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/06/2027
Actual
Sample size
Target
171
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Brazil
State/province [2] 0 0
SP
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Jordan
State/province [5] 0 0
Amman

Funding & Sponsors
Primary sponsor type
Other
Name
University Health Network, Toronto
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sunnybrook Health Sciences Centre
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Victoria Regional Health Centre
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
AC Camargo Cancer Center
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
King Hussein Cancer Center
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Tata Memorial Hospital
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
NYU Langone Health
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Centre hospitalier de l'Université de Montréal (CHUM)
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Peter MacCallum Cancer Centre, Australia
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
CHU de Quebec (Université Laval)
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
l'Hopital Maisonneuve-Rosemont
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
L'Institut de recherche du Centre universitaire de sante McGill
Address [11] 0 0
Country [11] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Danielle Rodin, MD
Address 0 0
Princess Margaret Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Danielle Rodin, MD
Address 0 0
Country 0 0
Phone 0 0
(416) 946-6513
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05592938