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

A Multicentre Prospective Cohort Study: 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Neoplasms; Lipid Profile

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Adjuvant chemotherapy group（Hormone receptor negative breast cancer）; Patients receiving adjuvant chemotherapy after surgery for hormone receptor-negative breast cancer
Adjuvant chemotherapy group（Hormone receptor positive breast cancer）; Patients receiving adjuvant chemotherapy after surgery for hormone receptor-positive breast cancer
Without adjuvant chemotherapy group（Hormone receptor positive breast cancer）; Patients without adjuvant chemotherapy after surgery for hormone receptor-positive breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who developed LDL-C abnormalities in 3 groups	Observe and compare differences between groups	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who developed TC，LDL-C，and TG abnormalities in 3 groups	Observe and compare differences between groups	2 years
Proportion of patients developing fatty liver in 3 groups	Observe and compare differences between groups	2 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 4, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NCC3872

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No