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

NCT02765373 | Unknown

• 1 other identifier: CH-BC-030
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

aromatase inhibitors; lipid levels

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

Exemestane DRUG

steroidal aromatase inhibitors(AIs)

Letrozole DRUG

non-steroidal aromatase inhibitors(AIs)

Anastrozole DRUG

non-steroidal aromatase inhibitors(AIs)

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).
• The patients have received surgery for breast cancer and recovered well for an interval of at least 1 week.
• 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.
• 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).
• Do not receive concomitant endocrine therapy, e.g. drug-induced menopause, tamoxifen.
• The patients do not have severe cardiopulmonary dysfunction.
• ECOG score: 0-1
• 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
• Serum low density lipoprotein-cholesterol(LDL-C) value \<3.37mmol/L
• Imaging examination identifies none of local recurrence or distal metastasis.
• No other combined malignancy.
• 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.

You may not qualify if:

• The patients are not qualified to receive the adjuvant endocrine therapy with AIs.
• 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)
• The patients received or are receiving the lipid-lowering therapy.
• The patients suffer from other combined malignancy.
• The patients have uncontrollable mental illness.
• 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).

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 32518597 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Letrozole; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Peng Yuan

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: May 6, 2016
• Study Start: January 1, 2015
• Primary Completion: January 1, 2020
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

CN (1)