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Trial registered on ANZCTR


Registration number
ACTRN12622000991718
Ethics application status
Approved
Date submitted
27/06/2022
Date registered
14/07/2022
Date last updated
27/09/2023
Date data sharing statement initially provided
14/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Does hormonal contraception use increase breast cancer risk for BRCA1 and BRCA2 mutation carriers?
Scientific title
Assessing the association between hormonal contraception and breast cancer risk for BRCA1 and BRCA2 mutation carriers using prospective data
Secondary ID [1] 305681 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 324155 0
Condition category
Condition code
Cancer 321629 321629 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
30
Target follow-up type
Years
Description of intervention(s) / exposure
Exposure: Any form of hormonal contraception including oral, implants or IUD
Duration of observation: Up to 30 years

Note: The data has already been collected therefore no active participant enrolment will occur for the current study.

The kConFab Clinical Follow-Up Study – Australia and New Zealand. Years of data collection: 1997 - 2019
The Breast Cancer Family Registry – Australia, United States and Canada. Years of data collection: 1993 -2018
Risk Factor Analysis of Hereditary Breast and Ovarian Cancer - Austria, Canada, Italy, Norway, Poland and United States. Years of data collection: 1991 - 2020
Basser Center/UPenn Registry – United States. Years of data collection: 1992 - 2020
Intervention code [1] 322079 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329399 0
Breast cancer - diagnosis of invasive breast cancer or Ductal Carcinoma In Situ (DCIS) Note: this is a composite primary outcome. Primary outcome was assessed through pathology reports/records and linkages to cancer registries.
Timepoint [1] 329399 0
Any time during follow-up up to 30 years after year of enrolment

Note: The time point is when the event happens, therefore it is different for every participant.
Secondary outcome [1] 402451 0
Nil
Timepoint [1] 402451 0
Nil

Eligibility
Key inclusion criteria
Pathogenic (class 4 or 5) BRCA1 or BRCA2 germline mutation
Follow-up information available
Born after 1920
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Personal history of cancer at cohort entry (except non-melanoma skin or CIN cervix)
History of bilateral mastectomy at cohort entry

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Cox regression will be applied, with age as the timescale and entry at study entry (baseline questionnaire date) and exit with breast cancer, bilateral mastectomy, death, diagnosis of other cancer, or last follow-up, whichever happens first. A cluster option will be used in the regression to model the non-independent observations due to family membership. Separate analyses will be undertaken for carriers of mutations in (i) BRCA1 (or both BRCA1 and BRCA2) and (ii) BRCA2. We will calculate unadjusted estimates and estimates adjusting for confounders. Multiple imputation using predictive mean matching, incorporating in the imputation process the various types of interval censoring information, will be used to deal with missing data. Sensitivity analyses will be conducted to assess the influence of potential biases.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/07/2022
Actual
19/07/2022
Date of last participant enrolment
Anticipated
19/07/2022
Actual
19/07/2022
Date of last data collection
Anticipated
14/09/2022
Actual
14/09/2022
Sample size
Target
5391
Accrual to date
Final
5391
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21077 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 21078 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 21079 0
Westmead Hospital - Westmead
Recruitment hospital [4] 21080 0
King Edward Memorial Hospital - Subiaco
Recruitment hospital [5] 21081 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [6] 21082 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [7] 21083 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [8] 22437 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [9] 22438 0
St George Hospital - Kogarah
Recruitment hospital [10] 22439 0
John Hunter Hospital - New Lambton
Recruitment hospital [11] 22440 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [12] 22441 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [13] 22442 0
Nepean Hospital - Kingswood
Recruitment hospital [14] 22443 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [15] 22444 0
Wollongong Hospital - Wollongong
Recruitment hospital [16] 22452 0
The Canberra Hospital - Garran
Recruitment hospital [17] 22453 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [18] 22454 0
The Wesley Hospital - Auchenflower
Recruitment hospital [19] 22455 0
Royal Hobart Hospital - Hobart
Recruitment hospital [20] 22456 0
Launceston General Hospital - Launceston
Recruitment hospital [21] 22457 0
North West Regional Hospital - Burnie
Recruitment postcode(s) [1] 35930 0
3000 - Melbourne
Recruitment postcode(s) [2] 35931 0
2031 - Randwick
Recruitment postcode(s) [3] 35932 0
2145 - Westmead
Recruitment postcode(s) [4] 35933 0
6008 - Subiaco
Recruitment postcode(s) [5] 35934 0
5006 - North Adelaide
Recruitment postcode(s) [6] 35935 0
3168 - Clayton
Recruitment postcode(s) [7] 35936 0
3052 - Parkville
Recruitment postcode(s) [8] 37655 0
3081 - Heidelberg West
Recruitment postcode(s) [9] 37657 0
2217 - Kogarah
Recruitment postcode(s) [10] 37660 0
2305 - New Lambton
Recruitment postcode(s) [11] 37662 0
2010 - Darlinghurst
Recruitment postcode(s) [12] 37664 0
2050 - Camperdown
Recruitment postcode(s) [13] 37666 0
2747 - Kingswood
Recruitment postcode(s) [14] 37668 0
2751 - Penrith
Recruitment postcode(s) [15] 37669 0
2065 - St Leonards
Recruitment postcode(s) [16] 37671 0
2500 - Wollongong
Recruitment postcode(s) [17] 37684 0
2605 - Curtin
Recruitment postcode(s) [18] 37685 0
4029 - Herston
Recruitment postcode(s) [19] 37687 0
4066 - Auchenflower
Recruitment postcode(s) [20] 37689 0
7000 - Hobart
Recruitment postcode(s) [21] 37690 0
7250 - Launceston
Recruitment postcode(s) [22] 37691 0
7320 - Burnie
Recruitment outside Australia
Country [1] 24256 0
New Zealand
State/province [1] 24256 0
Country [2] 24312 0
United States of America
State/province [2] 24312 0
Country [3] 24314 0
Canada
State/province [3] 24314 0
Country [4] 24767 0
Austria
State/province [4] 24767 0
Country [5] 24769 0
Italy
State/province [5] 24769 0
Country [6] 24770 0
Norway
State/province [6] 24770 0
Country [7] 24771 0
Poland
State/province [7] 24771 0

Funding & Sponsors
Funding source category [1] 310043 0
Charities/Societies/Foundations
Name [1] 310043 0
Cancer Council Victoria
Country [1] 310043 0
Australia
Primary sponsor type
Individual
Name
Kelly-Anne Phillips
Address
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 311091 0
None
Name [1] 311091 0
Address [1] 311091 0
Country [1] 311091 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309739 0
Peter Mac HREC
Ethics committee address [1] 309739 0
305 Grattan Street
Melbourne VIC 3000
Ethics committee country [1] 309739 0
Australia
Date submitted for ethics approval [1] 309739 0
14/07/1997
Approval date [1] 309739 0
13/08/1997
Ethics approval number [1] 309739 0
97/27

Summary
Brief summary
Women with a germline BRCA1 or BRCA2 mutation have markedly increased risks of early-onset breast cancer. The purpose of this study is to assess the association between hormonal contraceptives and breast cancer risk for BRCA1 and BRCA2 mutation carriers, using individual participant data from several cohort studies that have collected prospective data.

Who is it for?
This study will assess data on females who are aged 18 years or older (who were born after 1920), have a pathogenic (class 4 or 5) BRCA1 or BRCA2 germline mutation, do not have a personal history of cancer (except non-melanoma skin or CIN cervix) or history of bilateral mastectomy at cohort entry and have follow-up information available.

Study details
It is hypothesised that:
1) Current hormonal contraception is associated with an increased risk of breast cancer for BRCA1 and BRCA2 mutation carriers that decreases with time since last use
2) The association between current hormonal contraceptive use and breast cancer risk for BRCA1 and BRCA2 mutation carriers does not differ from that for the general population
3) Duration of use, age at first use, and use before first birth are not associated with breast cancer risk independently of current use and recency of use.

Studies of the association between oral contraceptive pill use and breast cancer risk for BRCA1 and BRCA2 mutation carriers have had conflicting results and there are no data are available regarding the risk of breast cancer associated with the use of other types of hormonal contraception, such as hormonal implants and hormonal intrauterine devices in BRCA1 and BRCA2 mutation carriers. Quantifying any association between use of hormonal contraceptives and breast cancer risk is very important for these women, because it will help optimise their personal breast cancer risk management plan.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115222 0
Prof Kelly-Anne Phillips
Address 115222 0
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Country 115222 0
Australia
Phone 115222 0
+61 3 8559 8261
Fax 115222 0
Email 115222 0
[email protected]
Contact person for public queries
Name 115223 0
Kelly-Anne Phillips
Address 115223 0
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Country 115223 0
Australia
Phone 115223 0
+61 3 8559 5000
Fax 115223 0
Email 115223 0
[email protected]
Contact person for scientific queries
Name 115224 0
Roger Milne
Address 115224 0
Cancer Council Victoria
615 St Kilda Road,
Melbourne, Victoria, 3004
Country 115224 0
Australia
Phone 115224 0
+61 3 9514 6100
Fax 115224 0
Email 115224 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13838Study protocol    383041-(Uploaded-27-06-2022-09-39-30)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.