Clinical trial · Observational
Investigation of Sex Hormone Levels in Chinese Women With Invasive Breast Cancer
NCT02263846CI-TRIAL-00017474completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Postmenopausal group
- description
- Patients at the age ≥ 60 years with more than one year of menopause, or patients having undergone bilateral oophorectomy.
- label
- Premenopausal group
- description
- Patients with regular menses during recent 3 months and having never received luteinizing hormone-releasing hormone analogue therapy.
Primary outcomes (1)
- measure
- The capability of sex hormones to discriminate between pre- and postmenopausal women with invasive breast cancer measured by four widely used methods and instruments in China.
- timeFrame
- Two years
- description
- Distribution characteristics of three hormones in pre- and postmenopausal patients are described with Kernel density estimation. Their discrimination capabilities are evaluated with operating characteristics (ROC) curve.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDSmith IE, Dowsett M, Yap YS, Walsh G, Lonning PE, Santen RJ, Hayes D. Adjuvant aromatase inhibitors for early breast cancer after chemotherapy-induced amenorrhoea: caution and suggested guidelines. J Clin Oncol. 2006 Jun 1;24(16):2444-7. doi: 10.1200/JCO.2005.05.3694. PMID 16735701