Five-year prognosis of postmenopausal patients with hormone receptor-positive early breast cancer treated with different stains and aromatase inhibitors: a prospective, randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000034035

Enrollment

Unknown

Registered

2020-06-21

Start date

2020-07-15

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

Lipophilic stain simvastatin treatment:Simvastatin

Hydrophilic stain simvastatin treatment:Pravastatin

Eligibility

Sex/Gender

Female

Age

50 Years to 70 Years

Inclusion criteria

Inclusion criteria: a) Age at 50-70 years, conforming to the criteria determining menopause in accordance with NCCN guideline b) Meeting hormone receptor-positive criteria. Pathologic analysis verifies to be invasive breast cancer while immunohistochemistry shows estrogen receptor (ER) and/or progesterone receptor (PR) positive (ER/PR) positive is defined that >1% of cells are positive c) Early breast cancer. It is defined as the disease confined to the breast with or without regional lymph node involvement, and absence of distant metastatic disease that is categorized as clinical stage I-IIIb and is treated by surgical resection. d) Patients receiving non-steroidal (letrozole or anastrozole) or steroidal (exemestane) aromatase inhibitors for 1 year who have abnormal serum LDL-C levels. - LDL-C level > 1.8 mmol/L in patients with atherosclerotic cardiovascular disease. - LDL-C level > 2.6 mmol/L in patients with diabetes, chronic kidney disease (stage 3 or 4) and hypertension. - LDL-C level > 3.4 mmol/L in patients with no other complications. e) An Eastern Cooperative Oncology Group (ECOG) score <=1. f) Provision of written informed consent.

Exclusion criteria

Exclusion criteria: a) History of liver and kidney damage or history of digestive ulcers; b) Patients who have received endocrine therapy for other diseases in the past; c) Allergy to AIs (i.e., anastrozole, letrozole or exemestane); d) Factors that have an obvious impact on oral drug absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction, etc.); e) Patients having a history of psychiatric illnesses; f) Patients who are unable to complete the expected trial due to other diseases.

Design outcomes

Secondary

Measure	Time frame
blood lipid levels;5-year disease-free survival;5-year overall survival;	—

Primary

Measure	Time frame
5-year relapse-free survival;	—

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