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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06888388




Registration number
NCT06888388
Ethics application status
Date submitted
15/03/2025
Date registered
21/03/2025

Titles & IDs
Public title
Long-term Safety of Nipple Sparing Mastectomy in Women With GPV in Breast Cancer
Scientific title
Long-term Oncologic Safety of Nipple Sparing Mastectomy in Women With High Penetrance Germline Pathogenic Variants in Breast Cancer Susceptibility Genes
Secondary ID [1] 0 0
MP-05-2025-4291 (MP)
Universal Trial Number (UTN)
Trial acronym
NSM
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Nipple Sparing Mastectomy (NSM)
Treatment: Surgery - Skin-Sparing Mastectomy (SSM)
Treatment: Surgery - Total (Simple) Mastectomy

Risk Reducing Mastectomy -

Active surveillance -


Treatment: Surgery: Nipple Sparing Mastectomy (NSM)
Nipple sparing mastectomy (NSM) is a surgical procedure which removes all macroscopic breast glandular tissue while retaining the skin as well as the nipple areola complex.

Treatment: Surgery: Skin-Sparing Mastectomy (SSM)
Skin sparing mastectomy (SSM) is a procedure that removes the nipple and areola complex along with all visible macroscopic breast glandular tissue.

Treatment: Surgery: Total (Simple) Mastectomy
Total (Simple) Mastectomy is a traditional mastectomy approach that removes the breast glandular tissue with a large overlying area of skin including the nipple and areola complex to allow for flat closure.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of breast cancer following RRM
Timepoint [1] 0 0
10 years
Secondary outcome [1] 0 0
Incidence of RRM
Timepoint [1] 0 0
10 years
Secondary outcome [2] 0 0
Incidence of post-operative complications
Timepoint [2] 0 0
10 years
Secondary outcome [3] 0 0
Incidence of pathologic outcomes following NSM
Timepoint [3] 0 0
10 years
Secondary outcome [4] 0 0
Number of participants using endocrine prevention
Timepoint [4] 0 0
10 years
Secondary outcome [5] 0 0
Number of participants who have undergone pre-mastectomy imaging and post-mastectomy surveillance
Timepoint [5] 0 0
10 years

Eligibility
Key inclusion criteria
* Assigned female sex at birth
* Age 18 years or older
* Confirmed GPV in BRCA1, BRCA2, PALB2, TP53, CDH1 or PTEN identified on pre-symptomatic genetic testing
Minimum age
18 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of breast cancer prior to genetic testing
* History of ovarian cancer prior to genetic testing
* History of bilateral mastectomy performed prior to genetic testing
* Presence of a variant of uncertain significance (VUS) in the absence of another GPV in BRCA1, BRCA2, PALB2, TP53, CDH1 or PTEN.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
4700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Melbourne, Peter MacCallum Cancer Center - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Belgium
State/province [5] 0 0
Antwerpen
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Portugal
State/province [9] 0 0
Lisbon

Funding & Sponsors
Primary sponsor type
Other
Name
Sir Mortimer B. Davis - Jewish General Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Research Society
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Quebec Breast Cancer Foundation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stephanie Wong, MD
Address 0 0
Country 0 0
Phone 0 0
5143408222
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06888388