Effects of Adjuvant Endocrine Therapy With Aromatase Inhibitors on the Postoperative Lipid Levels in Postmenopausal Breast Cancer Patients

This study is a prospective, controlled phase IV clinical trial among postmenopausal patients with hormone receptor-positive breast cancer.The main purpose is to compare the effects of steroidal aromatase inhibitor (AI) exemestane and non-steroidal AIs on the lipid levels of breast cancer patients.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Letrozole; Drug: Anastrozole; Drug: Exemestane

Detailed Description

The study subjects are composed of postmenopausal women with hormone receptor-positive breast cancer who have received exemestane, anastrozole or letrozole followed by testing of safety variables such as low-density lipoprotein- cholesterol (LDL-C), triglyceride(TC), total cholesterol, high-density lipoprotein cholesterol(HDL), blood calcium, transaminase and fasting plasma glucose at different time intervals in two years.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

postmenopausal women with hormone receptor-positive breast cancer who have received surgery

Description

Inclusion Criteria:

1. Pathologic analysis verifies to be early-stage 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).
2. The patients have received surgery for breast cancer and recovered well for an interval of at least 1 week.
3. The patients have received post-operational adjuvant chemotherapy and/or adjuvant radiotherapy whereas the interval of chemotherapy and/or adjuvant radiotherapy is more than 2 weeks.
4. The postmenopausal women have been confirmed to be to menopausal as defined in NCCN guidelines(including post bilateral oophorectomy; age≥60 year-old; age≤60 year-old, menopause for more than 1 year and plasma Follicle-Stimulating Hormone (FSH) and estradiol levels meet the menopausal scope).
5. Do not receive concomitant endocrine therapy, e.g. drug-induced menopause, tamoxifen.
6. The patients do not have severe cardiopulmonary dysfunction.
7. ECOG score: 0-1

8. The patients have enough organ function and meet the scope of aromatase inhibitors(AIs) therapy. The laboratory test indexes must comply with the following requirements:

   Blood routine: neutrophil≥1.5G/L, platelet count ≥75G/L, hemoglobin ≥100g/L Liver function: serum bilirubin ≤ 2 times the upper limit of normal value; ALT and AST≤3 times the upper limit of normal value; Renal function: serumcreatinine≤140μmol/L

9. Serum low density lipoprotein-cholesterol(LDL-C) value <3.37mmol/L
10. Imaging examination identifies none of local recurrence or distal metastasis.
11. No other combined malignancy.
12. The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.

Exclusion criteria

1. The patients are not qualified to receive the adjuvant endocrine therapy with AIs.
2. The patients previously received other endocrine therapy (e.g. tamoxifen) simultaneity or the treatment with AIs (excluding those with a course of less than 3 months)
3. The patients received or are receiving the lipid-lowering therapy.
4. The patients suffer from other combined malignancy.
5. The patients have uncontrollable mental illness.
6. The patients experience severe cardiovascular diseases in the recent 6 months (e.g. unstable angina, chronic heart failure, uncontrollable hypertension >150/90 mmHg, myocardial infarction or cerebrovascular disorders).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
steroidal aromatase inhibitors(AIs); Exemestane 25mg Qd for 5 years	Drug: Exemestane
non-steroidal aromatase inhibitors(AIs); Letrozole 2.5mg Qd or Anastrozole 1mg Qd for 5 years	Drug: Letrozole; Drug: Anastrozole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio of patients whose low density lipoprotein-cholesterol（LDL-C） level ≥ 4.14 mmol/L in 2 years of administration among groups	Change of LDL-C level from Baseline to up to 2 years

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Wang X, Zhu A, Wang J, Ma F, Liu J, Fan Y, Luo Y, Zhang P, Li Q, Xu B, Yuan P. Steroidal aromatase inhibitors have a more favorable effect on lipid profiles than nonsteroidal aromatase inhibitors in postmenopausal women with early breast cancer: a prospective cohort study. Ther Adv Med Oncol. 2020 May 26;12:1758835920925991. doi: 10.1177/1758835920925991. eCollection 2020. Erratum In: Ther Adv Med Oncol. 2020 Aug 25;12:1758835920956880.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: April 8, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: aromatase inhibitors; lipid levels
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole; Anastrozole; Exemestane
• Other Study ID Numbers: CH-BC-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED