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Does hormonal contraception use increase breast cancer risk for BRCA1 and BRCA2 mutation carriers?

Assessing the association between hormonal contraception and breast cancer risk for BRCA1 and BRCA2 mutation carriers using prospective data

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000991718
Enrollment
5391
Registered
2022-07-14
Start date
2022-07-19
Completion date
2022-07-19
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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

Sponsors

Kelly-Anne Phillips
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pathogenic (class 4 or 5) BRCA1 or BRCA2 germline mutation Follow-up information available Born after 1920

Exclusion criteria

Personal history of cancer at cohort entry (except non-melanoma skin or CIN cervix) History of bilateral mastectomy at cohort entry

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026