Clinical trial NCT06405269: Effect of (neo)Adjuvant Therapy on Lipids in Young Breast Cancer Patients
Official title: A Multicentre Prospective Cohort Study: Effect of (neo)Adjuvant Therapy on Lipids in Young Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Neoplasms
Lipid Profile
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young breast cancer patients who fulfil the following criteria: less than or equal to 40, surgically resectable, requiring (neo)adjuvant chemotherapy or endocrine therapy.

Brief summary: 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.


Eligibility criteria: 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: \&lt;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

Primary outcomes:
measure: Proportion of patients who developed LDL-C abnormalities in 3 groups
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of patients who developed TC，LDL-C，and TG abnormalities in 3 groups
timeFrame: 2 years
measure: Proportion of patients developing fatty liver in 3 groups
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: