Long-term Use of CCB and Breast Cancer Risk

August 1, 2023 updated by: Rachael Moorin, Curtin University

Association of Long-term Use of Calcium Channel Blockers (CCB) and Risk of Breast Cancer: A Retrospective Longitudinal Observational Study

The goal of this retrospective observational study is to examine whether long-term calcium channel blocker (CCB) use is associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands . The main questions it aims to answer are:

  • Is long-term CCB use associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands and what is the dose-response nature of this association.
  • Does differences in the association between calcium channel blocker use and the development of breast cancer exist between Australian and Dutch women.

The investigators will utilise data from the Australian Longitudinal Study on Women's Health (ALSWH) , 45 and Up Study and Rotterdam study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Aims: To examine the association between long-term calcium channel blocker (CCB) use and the development of breast cancer.

Data sources: the Australian Longitudinal Study on Women's Health , 45 and Up Study, Rotterdam study and linked administrative data.

Study cohort: Women with self-reported hypertension (HTN) without prior breast cancer.

Harmonisation: Relevant variables will be checked for harmonisation in which variables available in all three cohort will be used in the harmonised analysis. The variables will be checked on the definition, measurement and harmonisation rules. Variables that cannot be harmonised across the cohorts will be used in the cohort specific analyses.

Exposure measurement: The primary exposure is the use of CCB, which will be identified by the anatomical therapeutic chemical code (C08) in the medicine data. Exposure to CCB as well as other antihypertensive (AHT) medicines will be captured separately as the cumulative dose-duration of exposure during follow up. Participants will be stratified in four groups: women with HTN with no AHT use, women with HTN exposed to CCB only, women with HTN exposed to non-CCB and women with HTN exposed to both CCB and non-CCB.

Outcome measurement: Data on a diagnosis of invasive breast cancer will be obtained from cancer registries and hospital admission data using ICD-10 code of C50.x.

Potential confounders: age, education, marital status, socioeconomic status, body mass index, diabetes, heart disease, stroke, age when had first child, parity, history of hysterectomy or oophorectomy, use of hormonal contraception, use of hormonal replacement therapy.

Statistical analysis: The association between CCB use and breast cancer risk will be estimated by the Fine and Gray competing risk regression model in which a first diagnosis of invasive breast cancer will be treated as the principle event and death and bilateral mastectomy (without a diagnosis of breast cancer) will be competing risks. The nonlinear threshold models will be used to capture any differential effect of the cumulative dose-duration of CCB while simultaneously accounting for the cumulative dose-duration of other AHT exposure on breast cancer risk. Other confounders will be accounted for in the models using propensity scores.

Implications: Results from this study will contribute to addressing the concerns about using CCB for hypertension treatment in women, particularly in those who have high risk of breast cancer.

Study Type

Observational

Enrollment (Estimated)

68500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Bentley, Western Australia, Australia, 6102
        • Curtin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The study will include eligible women enrolled in three longitudinal cohorts: ALSWH, 45 and Up Study and the Rotterdam study.

Description

Inclusion criteria:

  • Alive and still enrolled in the longitudinal cohort at the study entry (2004 to 2009)
  • Self-reported/diagnosed hypertension at study entry.

Exclusion criteria:

+ A history of breast cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No AHT
Women with HTN with no AHT use
Drug: None AHT
None AHT
AHT but non-CCB
Women with HTN exposed to other antihypertensive medicines but not exposed to calcium channel blockers
Drug: Beta blocker
Drugs with ATC code C07 will be categorised as beta-blockers.
Drug: Diuretic
Drugs with ATC code C03 will be categorised as diuretics.
Drug: RAS
Drugs with ATC code C09 will be categorised as RAS (agents acting on the renin angiotensin system).
Drug: Other AHT
Drugs with ATC code C02 will be categorised as other antihypertensives.
CCB only
Women with HTN exposed to calcium channel blockers but not exposed to other antihypertensive medicines
Drug: Calcium channel blocker
Drugs with ATC code C08 will be categorised as calcium channel blockers.
Both CCB and non-CCB
Women with HTN exposed to both calcium channel blockers and other antihypertensive medicines.
Drug: Beta blocker
Drugs with ATC code C07 will be categorised as beta-blockers.
Drug: Diuretic
Drugs with ATC code C03 will be categorised as diuretics.
Drug: RAS
Drugs with ATC code C09 will be categorised as RAS (agents acting on the renin angiotensin system).
Drug: Other AHT
Drugs with ATC code C02 will be categorised as other antihypertensives.
Drug: Calcium channel blocker
Drugs with ATC code C08 will be categorised as calcium channel blockers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incident rate of invasive breast cancer
Time Frame: From cohort entry until the earliest date of one of the following: a diagnosis of invasive breast cancer, bilateral mastectomy (without breast cancer) or death, assessed up to 14 years.
The outcome will be defined based on the ICD-10 code of C50.x (malignant neoplasm of breast).
From cohort entry until the earliest date of one of the following: a diagnosis of invasive breast cancer, bilateral mastectomy (without breast cancer) or death, assessed up to 14 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Curtin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014896

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on None AHT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe