Measuring Estradiol Levels in Breast Cancer Patients During Hormone Therapy
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)
This study is testing how estradiol levels change in Chinese breast cancer patients on hormone therapy to see if it helps personalize their treatment better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06195202 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure serum estradiol (E2) levels in Chinese breast cancer patients undergoing endocrine therapy using high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The study will assess the proportion of patients with premenopausal E2 levels during treatment with aromatase inhibitors (AIs) or fulvestrant (FUL). Additionally, it seeks to explore the relationship between serum E2 levels and the effectiveness of endocrine therapy, ultimately aiming to enhance individualized treatment strategies for patients.
Who should consider this trial
Good fit: Ideal candidates include adult women over 18 with histologically confirmed early or advanced breast cancer receiving specific endocrine therapies.
Not a fit: Patients currently using tamoxifen for endocrine therapy or those who have exceeded the recommended lines of treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective endocrine therapy for breast cancer patients.
How similar studies have performed: While this approach is novel in the context of this specific patient population, similar studies have shown promise in measuring hormone levels to tailor cancer treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Cong Xue, Dr
- Email: xuecong@sysucc.org.cn
- Phone: 8620-87342490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.