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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05972785
Ethics application status
Date submitted
24/07/2023
Date registered
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?
No
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
Trial website
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

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05972785