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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Invitation-only

Conditions

Lipid Profile

Breast Neoplasms

Study type

Observational

Funder types

Other

Identifiers

NCT06405269

NCC3872

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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