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

NCT ID: NCT06405269

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2029-05-01

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.

Conditions

Breast Neoplasms; Lipid Profile

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adjuvant chemotherapy group（Hormone receptor negative breast cancer）

Patients receiving adjuvant chemotherapy after surgery for hormone receptor-negative breast cancer

No interventions assigned to this group

Adjuvant chemotherapy group（Hormone receptor positive breast cancer）

Patients receiving adjuvant chemotherapy after surgery for hormone receptor-positive breast cancer

No interventions assigned to this group

Without adjuvant chemotherapy group（Hormone receptor positive breast cancer）

Patients without adjuvant chemotherapy after surgery for hormone receptor-positive breast cancer

No interventions assigned to this group

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: <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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

PENG YUAN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

NCC3872

Identifier Type: -

Identifier Source: org_study_id