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Effects of aromatase inhibitors on blood lipids in postmenopausal patients with hormone receptor-positive breast cancer in northern China and prognosis of treatment with different lipid-lowering drugs: study protocol for a prospective, multi-center, open-label, randomized, parallel-group, controlled, two-phase trial

Effects of aromatase inhibitors on blood lipids in postmenopausal patients with hormone receptor-positive breast cancer in northern China and prognosis of treatment with different lipid-lowering drugs: study protocol for a prospective, multi-center, open-label, randomized, parallel-group, controlled, two-phase trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024790
Enrollment
Unknown
Registered
2019-07-27
Start date
2019-12-01
Completion date
Unknown
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Steroidal AI group:Exemestane
Non-steroidal AI group:Letrozole or anastrozole

Sponsors

The First Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 50-70 years, conforming to the criteria determining menopause in accordance with NCCN guideline; 2. Meet the standard of positive hormone receptor; 3. Early breast cancer; 4. Patients receiving adjuvant AI therapy after radical mastectomy for breast cancer; 5. An Eastern Cooperative Oncology Group (ECOG) score <=1; 6. Developing critical lipid abnormalities at 1 dose of administration; 7. Provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1. History of liver and kidney damage or history of digestive ulcers; 2. Those who have received endocrine therapy in the past; 3. Allergy to AIs; 4. Those who are unable to complete the expected trial due to other diseases; 5. Factors that have a significant impact on oral drug absorption; 6. Other serious physical or psychiatric illnesses or laboratory abnormalities, which may be worsened by participation in this trial or may interfere with the results of this trial. Upon the request of the investigators for safety reasons.

Design outcomes

Primary

MeasureTime frame
Percentage of patients with dyslipidemia;5-year DFS;

Secondary

MeasureTime frame
Changes in blood lipid levels;5-year OS after AI therapy;

Countries

China

Contacts

Public ContactFeng Jin

The First Hospital of China Medical University

jinfeng66cn@hotmail.com+86 13998890665

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026