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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05972785




Registration number
NCT05972785
Ethics application status
Date submitted
24/07/2023
Date registered
2/08/2023
Date last updated
2/08/2023

Titles & IDs
Public title
Long-term Use of CCB and Breast Cancer Risk
Scientific title
Association of Long-term Use of Calcium Channel Blockers (CCB) and Risk of Breast Cancer: A Retrospective Longitudinal Observational Study
Secondary ID [1] 0 0
2014896
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension,Essential 0 0
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Calcium channel blocker
Treatment: Drugs - Beta blocker
Treatment: Drugs - Diuretic
Treatment: Drugs - RAS
Treatment: Drugs - Other AHT
Treatment: Drugs - None AHT

No AHT - Women with HTN with no AHT use

AHT but non-CCB - Women with HTN exposed to other antihypertensive medicines but not exposed to calcium channel blockers

CCB only - Women with HTN exposed to calcium channel blockers but not exposed to other antihypertensive medicines

Both CCB and non-CCB - Women with HTN exposed to both calcium channel blockers and other antihypertensive medicines.


Treatment: Drugs: Calcium channel blocker
Drugs with ATC code C08 will be categorised as calcium channel blockers.

Treatment: Drugs: Beta blocker
Drugs with ATC code C07 will be categorised as beta-blockers.

Treatment: Drugs: Diuretic
Drugs with ATC code C03 will be categorised as diuretics.

Treatment: Drugs: RAS
Drugs with ATC code C09 will be categorised as RAS (agents acting on the renin angiotensin system).

Treatment: Drugs: Other AHT
Drugs with ATC code C02 will be categorised as other antihypertensives.

Treatment: Drugs: None AHT
None AHT
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incident rate of invasive breast cancer
Timepoint [1] 0 0
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.

Eligibility
Key inclusion criteria
Inclusion criteria:

- Alive and still enrolled in the longitudinal cohort at the study entry (2004 to 2009)

- Self-reported/diagnosed hypertension at study entry.
Minimum age
45 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Key exclusion criteria
Exclusion criteria:

+ A history of breast cancer.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
68500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Curtin university - Bentley
Recruitment postcode(s) [1] 0 0
6102 - Bentley

Funding & Sponsors
Primary sponsor type
Other
Name
Curtin University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05972785
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries