Investigation of Sex Hormone Levels in Chinese Women With Invasive Breast Cancer

Affiliated Hospital to Academy of Military Medical Sciences

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02263846

CBCSG008

Details and patient eligibility

About

This study is to investigate sex hormones levels of Chinese patients with invasive breast cancer.The aim is to analyze biochemical monitoring results of premenopausal and postmenopausal patients to facilitate determination of menopausal status and propose clinical application.

Full description

Follicle stimulating hormone (FSH), estradiol (E2) and luteinizing hormone (LH) can serve as indicators in the determination of menopausal status. NCCN clinical practice guidelines for breast cancer recommend detecting the levels of FSH and E2 for amenorrhea patients less than 60 years of age. But the detection method and the corresponding reference ranges indicating postmenopausal status are not mentioned. In addition, the reference limits vary a lot among different equipments and methods when it comes to diagnosis of menopause, thus it is difficult to set universal criteria. So in this study, four widely used methods and instruments in China are used to detect plasma levels of FSH, E2 and LN of premenopausal and postmenopausal patients. Instruments and methods must be one of the following four categories: microparticle chemiluminescent(Beckman),acridinium ester chemiluminescence (Siemens),acridinium ester chemiluminescence (Abbott) and electrochemiluminescence（Roche）.

Enrollment: 1,183 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Invasive breast cancer patients confirmed through pathology.
• For postmenopausal group: patients at the age ≥ 60 years with more than one year of menopause, or patients having undergone bilateral oophorectomy.
• For premenopausal group: patients with regular menses during recent 3 months and having never received luteinizing hormone-releasing hormone (LHRH) analogue therapy.
• Patients who meet the above criteria can be enrolled whether they have received anti-cancer treatment or not.

Exclusion criteria

• patients less than 60 years old who are amenorrhoeic but have not received bilateral oophorectomy or medical castration.

Trial design

1,183 participants in 2 patient groups

Postmenopausal group

Description:

Patients at the age ≥ 60 years with more than one year of menopause, or patients having undergone bilateral oophorectomy.

Premenopausal group

Description:

Patients with regular menses during recent 3 months and having never received luteinizing hormone-releasing hormone analogue therapy.