Observing treatment outcomes for Chinese patients with advanced breast cancer and ESR1 mutations
Effectiveness and Safety of Different Treatment Regimens in Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer After Failure of Prior Endocrine Therapy: a Prospective, Non-interventional, Real-world Study
SciClone Pharmaceuticals · NCT06548919
This study looks at how well different treatments work for Chinese patients with advanced breast cancer and specific gene mutations who haven't had success with previous hormone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | SciClone Pharmaceuticals (industry) |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06548919 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of various treatment regimens in Chinese patients diagnosed with ESR1-mutated HR+/HER2-advanced breast cancer who have previously failed endocrine therapy. The study will collect epidemiological data and monitor efficacy and safety indicators every 2-3 months until disease progression or other specified endpoints. Participants will be followed for a defined period to gather comprehensive data on their treatment outcomes in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates include postmenopausal women aged 18 and older with confirmed ESR1 mutations and advanced breast cancer who have progressed on prior endocrine therapy.
Not a fit: Patients who are pregnant, breastfeeding, or unable to tolerate oral medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into effective treatment options for patients with ESR1-mutated advanced breast cancer.
How similar studies have performed: While this study focuses on a specific mutation in a defined population, similar observational studies have shown promise in understanding treatment efficacy in advanced breast cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment. * 2\. female ≥ 18 years of age * 3\. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old \< age ≤ 60 years old with 1 year of menopause. d) Age \<60 years and receiving ovarian suppression therapy. * 4\. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed. * 5\. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy. * 6\. have normal organ function (as assessed by the investigator). Exclusion Criteria: * 1\. women who are pregnant or breastfeeding * 2\. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements * 3\. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator
Where this trial is running
Suzhou, Jiangsu
- Tianjin Haidafu Internet Hospital — Suzhou, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: Chunyang Li
- Email: lichunyang@sciclone.com
- Phone: 86-15216717343
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.
Conditions: ESR1 Gene Mutation, Advanced Breast Cancer