Effect of (neo)Adjuvant Therapy on Lipids in Young Breast Cancer Patients

Previous studies have shown differences in the effects of different endocrine drugs on blood lipids in breast cancer, and dyslipidaemia is a major risk factor for cardiovascular disease, and it has been previously reported that the leading cause of death in postmenopausal patients with breast cancer is cardiovascular disease, but the effects of endocrine drug therapy on blood lipids in young breast cancer patients (age ≤40) are not clear. Previously, our group conducted a preliminary retrospective analysis of young patients on endocrine therapy and found that dyslipidaemia was also a common adverse effect of treatment in young breast cancer patients; therefore, dyslipidaemia induced by antineoplastic therapy not only occurs in postmenopausal patients, but is also prevalent in premenopausal and even younger patients. Therefore, this study intends to evaluate the effects of different treatment regimens on lipids in early-stage young breast cancer patients and to explore the optimal timing of lipid-lowering drug interventions to provide a basis for clinical practice.

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Key information

Conditions

Breast Neoplasms Breast Diseases Lipid Profile Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ECOG score 0-1
Resectable breast cancer
No distant metastases on postoperative imaging assessment
Patients proposed for (neo)adjuvant therapy
No previous oral lipid-lowering drugs, serum LDL-C level within normal range, i.e. LDL-C value: <3.4 mmol/L
No fatty liver by liver ultrasound/CT examination
No major organ dysfunction

Exclusion criteria

Patients with pre-existing hyperlipidaemia, coronary heart disease, fatty liver disease, or who have received or are receiving lipid-lowering medication
Enrolled in another study or less than or equal to 4 weeks since discontinuation of other medications
Presence of severe dysfunction of vital organs
Patients with other malignancies (except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumours that have been cured for at least 5 years)
Acute infectious diseases or chronic infectious diseases in active stage
History of uncontrolled epilepsy, central nervous system disease or mental disorder

Treatment and study plan

Primary outcomes

Proportion of patients who developed LDL-C abnormalities in 3 groups

Time frame: 2 years

Observe and compare differences between groups

Secondary outcomes

Proportion of patients who developed TC，LDL-C，and TG abnormalities in 3 groups

Time frame: 2 years

Observe and compare differences between groups
Proportion of patients developing fatty liver in 3 groups

Time frame: 2 years

Observe and compare differences between groups

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

A Multicentre Prospective Cohort Study: Effect of (neo)Adjuvant Therapy on Lipids in Young Breast Cancer Patients

Important dates

Study start: 2024
Primary completion: 2029
Study completion: 2029
First posted: May 8, 2024
Registry last updated: Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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