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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Unknown

Conditions

Breast Cancer

Treatments

Drug: Letrozole
Drug: Anastrozole
Drug: Exemestane

Study type

Observational

Funder types

Other

Identifiers

NCT02765373
CH-BC-030

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

Female

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • 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.

Exclusion criteria

  • 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).

Trial design

500 participants in 2 patient groups

steroidal aromatase inhibitors(AIs)
Description:
Exemestane 25mg Qd for 5 years
Treatment:
Drug: Exemestane
non-steroidal aromatase inhibitors(AIs)
Description:
Letrozole 2.5mg Qd or Anastrozole 1mg Qd for 5 years
Treatment:
Drug: Anastrozole
Drug: Letrozole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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