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Serum Estradiol (E2) Levels in Breast Cancer Patients During Endocrine Therapy by High Performance Liquid Chromatography-tandem Mass Spectrometry (LC-MS /MS)

StatusUnknown
PhaseNot specified
Started2023-09-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 9, 2024 (before its estimated August 31, 2024 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
Trial status changed: Recruiting → Unknown
2024-01-07
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Eligibility v1
Trial statusRecruiting→Unknown
Eligibility criteria-21 characters
Inclusion Criteria: 1. Over 18 years old; 2. Histologically confirmed breast cancer; 3. Patients with early breast cancer (including natural menopa [...] ciclib or Ribociclib) + fluvestrant (FUL) endocrine therapy; 4. Patients with needs for hormone testing; 5. Standard treatment, complete clinical data, including compl [...] efficacy evaluation and follow-up data. Exclusion Criteria: 1. Breast cancer patients using TAM endocrine therapy; 2. In advanced patients, AIs exceeded first-line use (that is, [...]
Study title-30 characters
A Prospective Cohort Study of Serum Estradiol (E2) Levels in Breast Cancer Patients During [...]
2024-01-05
Original filing
The investigators intend to conduct a prospective cohort study to detect E2 levels during endocrine therapy in Chinese breast cancer patients using LC-MS/MS methods, and to determine the proportion of patients with premenopausal E2 levels (OFR or E2 insufficiency) during AIs or FUL endocrine therapy. To further explore the correlation between serum E2 levels and the efficacy of endocrine therapy in Chinese patients, so as to ensure the safety and efficacy of endocrine therapy for patients, and pave the way for further providing more accurate individualized treatment programs.
Trial Details
NCT Number NCT06195202
Lead Sponsor Sun Yat-sen University
Conditions Breast Cancer
Enrollment 2,000 participants
Start Date 2023-09-01
Primary Completion 2024-08-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2024-01-09