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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06195202

Enrollment

2000

Registered

2024-01-08

Start date

2023-09-01

Completion date

2026-08-31

Last updated

2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

LC MS/MS, estradiol

Brief summary

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.

Interventions

DRUGAIs

Patients with AIs

DRUGOFS+AIs

Patients with OFS+AIs

DRUGFUL

Patients with FUL

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Over 18 years old; * Histologically confirmed breast cancer; * Patients with early breast cancer (including natural menopause and artificial menopause using LHRHa), or patients with advanced breast cancer (including natural menopause and artificial menopause using LHRHa) who use AIs (letrozole, anastrozole or exemestane) as adjuvant endocrine therapy, First-line CDK4/6 inhibitors (Palbociclib, Dalpiciclib, Abemaciclib or Ribociclib) +AI endocrine therapy, second-line CDK4/6 inhibitors (Palbociclib, Dalpiciclib, Abemaciclib or Ribociclib) + fluvestrant (FUL) endocrine therapy; * Patients with needs for hormone testing; * Standard treatment, complete clinical data, including complete efficacy evaluation and follow-up data.

Exclusion criteria

* Breast cancer patients using TAM endocrine therapy; * In advanced patients, AIs exceeded first-line use (that is, in advanced disease, one endocrine therapy regimen had been used and failed), and FUL exceeded second-line use (that is, more than one endocrine therapy regimen had been used and failed)

Design outcomes

Primary

Measure	Time frame	Description
The serum E2 levels in breast cancer patients during endocrine therapy.	From enrollment to 1 months	Consistency between 2 methods

Countries

China

Contacts

Primary ContactCong Xue, Dr

xuecong@sysucc.org.cn8620-87342490

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026