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

January 7, 2024 updated by: Cong Xue, Sun Yat-sen University

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Cong Xue, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

2023.9-2024.68 Breast cancer patients who received aromatase inhibitor (AIs) or fulvestrant (FUL) endocrine therapy in Sun Yat-sen University Cancer Center and need to test hormone levels.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AI
Patients with AIs
Drug: AIs
Patients with AIs
OFS+AI
Patients with OFS+AIs
Drug: OFS+AIs
Patients with OFS+AIs
FUL
Patients with FUL
Drug: FUL
Patients with FUL

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

December 24, 2023

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2023-351-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not yet decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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