ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breast cancer

Condition category

Condition code

Cancer

Breast

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

Nil

Timepoint [1]

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?

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]

Peter MacCallum Cancer Centre - Melbourne

Recruitment hospital [2]

Prince of Wales Hospital - Randwick

Recruitment hospital [3]

Westmead Hospital - Westmead

Recruitment hospital [4]

King Edward Memorial Hospital - Subiaco

Recruitment hospital [5]

Womens and Childrens Hospital - North Adelaide

Recruitment hospital [6]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [7]

Royal Melbourne Hospital - Royal Park campus - Parkville

Recruitment hospital [8]

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Recruitment hospital [9]

St George Hospital - Kogarah

Recruitment hospital [10]

John Hunter Hospital - New Lambton

Recruitment hospital [11]

St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [12]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [13]

Nepean Hospital - Kingswood

Recruitment hospital [14]

Royal North Shore Hospital - St Leonards

Recruitment hospital [15]

Wollongong Hospital - Wollongong

Recruitment hospital [16]

The Canberra Hospital - Garran

Recruitment hospital [17]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [18]

The Wesley Hospital - Auchenflower

Recruitment hospital [19]

Royal Hobart Hospital - Hobart

Recruitment hospital [20]

Launceston General Hospital - Launceston

Recruitment hospital [21]

North West Regional Hospital - Burnie

Recruitment postcode(s) [1]

3000 - Melbourne

Recruitment postcode(s) [2]

2031 - Randwick

Recruitment postcode(s) [3]

2145 - Westmead

Recruitment postcode(s) [4]

6008 - Subiaco

Recruitment postcode(s) [5]

5006 - North Adelaide

Recruitment postcode(s) [6]

3168 - Clayton

Recruitment postcode(s) [7]

3052 - Parkville

Recruitment postcode(s) [8]

3081 - Heidelberg West

Recruitment postcode(s) [9]

2217 - Kogarah

Recruitment postcode(s) [10]

2305 - New Lambton

Recruitment postcode(s) [11]

2010 - Darlinghurst

Recruitment postcode(s) [12]

2050 - Camperdown

Recruitment postcode(s) [13]

2747 - Kingswood

Recruitment postcode(s) [14]

2751 - Penrith

Recruitment postcode(s) [15]

2065 - St Leonards

Recruitment postcode(s) [16]

2500 - Wollongong

Recruitment postcode(s) [17]

2605 - Curtin

Recruitment postcode(s) [18]

4029 - Herston

Recruitment postcode(s) [19]

4066 - Auchenflower

Recruitment postcode(s) [20]

7000 - Hobart

Recruitment postcode(s) [21]

7250 - Launceston

Recruitment postcode(s) [22]

7320 - Burnie

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Country [2]

United States of America

State/province [2]

Country [3]

Canada

State/province [3]

Country [4]

Austria

State/province [4]

Country [5]

Italy

State/province [5]

Country [6]

Norway

State/province [6]

Country [7]

Poland

State/province [7]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cancer Council Victoria

Address [1]

615 St Kilda Road,
Melbourne, Victoria, 3004,

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter Mac HREC

Ethics committee address [1]

305 Grattan Street
Melbourne VIC 3000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/07/1997

Approval date [1]

13/08/1997

Ethics approval number [1]

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

Prof Kelly-Anne Phillips

Address

Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000

Country

Australia

Phone

+61 3 8559 8261

Fax

[email protected]

Contact person for public queries

Name

Kelly-Anne Phillips

Address

Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000

Country

Australia

Phone

+61 3 8559 5000

Fax

[email protected]

Contact person for scientific queries

Name

Roger Milne

Address

Cancer Council Victoria
615 St Kilda Road,
Melbourne, Victoria, 3004

Country

Australia

Phone

+61 3 9514 6100

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13838	Study 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.

Trial Review

Documents added manually

Documents added automatically