NCT05972785

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 Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

July 24, 2023

Last Update Submit

August 20, 2024

Conditions

Hypertension,EssentialBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Incident rate of invasive breast cancer

    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.

Study Arms (4)

No AHT

Women with HTN with no AHT use

Drug: None AHT

AHT but non-CCB

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

Drug: Beta blockerDrug: DiureticDrug: RASDrug: Other AHT

CCB only

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

Drug: Calcium channel blocker

Both CCB and non-CCB

Women with HTN exposed to both calcium channel blockers and other antihypertensive medicines.

Drug: Calcium channel blockerDrug: Beta blockerDrug: DiureticDrug: RASDrug: Other AHT

Interventions

Calcium channel blockerDRUG

Drugs with ATC code C08 will be categorised as calcium channel blockers.

Both CCB and non-CCBCCB only
Beta blockerDRUG

Drugs with ATC code C07 will be categorised as beta-blockers.

AHT but non-CCBBoth CCB and non-CCB
DiureticDRUG

Drugs with ATC code C03 will be categorised as diuretics.

AHT but non-CCBBoth CCB and non-CCB
RASDRUG

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

AHT but non-CCBBoth CCB and non-CCB
Other AHTDRUG

Drugs with ATC code C02 will be categorised as other antihypertensives.

AHT but non-CCBBoth CCB and non-CCB
None AHTDRUG

None AHT

No AHT

Eligibility Criteria

Age45 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \+ A history of breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Curtin university

Bentley, Western Australia, 6102, Australia

Location

Related Publications (1)

  • Ho C, Ha NT, Youens D, Abhayaratna WP, Bulsara MK, Hughes JD, Mishra G, Pearson SA, Preen DB, Reid CM, Ruiter R, Saunders CM, Stricker BH, van Rooij FJA, Wright C, Moorin R. Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol. BMJ Open. 2024 Mar 8;14(3):e080982. doi: 10.1136/bmjopen-2023-080982.

    PMID: 38458796DERIVED

MeSH Terms

Conditions

Essential HypertensionBreast Neoplasms

Interventions

Calcium Channel BlockersAdrenergic beta-AntagonistsDiuretics

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Membrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCalcium-Regulating Hormones and AgentsPhysiological Effects of DrugsCardiovascular AgentsTherapeutic UsesAdrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsNatriuretic Agents

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 2, 2023

Study Start

July 1, 2022

Primary Completion

June 30, 2025

Study Completion

December 1, 2025

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)