Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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