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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AI

Patients with AIs

AIs

Intervention Type DRUG

Patients with AIs

OFS+AI

Patients with OFS+AIs

OFS+AIs

Intervention Type DRUG

Patients with OFS+AIs

FUL

Patients with FUL

FUL

Intervention Type DRUG

Patients with FUL

Interventions

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AIs

Patients with AIs

Intervention Type DRUG

OFS+AIs

Patients with OFS+AIs

Intervention Type DRUG

FUL

Patients with FUL

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No