NCT06548919Recruiting
Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 12 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+/HER2-advanced breast cancer after failure of endocrine therapy. Epidemiological data, efficacy and safety measures will be collected for each subject. Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression, receipt of a new anti-tumour treatment modality, death, loss to follow-up, and arrival at the data collection cut-off date. The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject, or 4 weeks after treatment discontinuation and subject discontinuation/withdrawal. Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 450 (estimated)
- First submitted
- 7 Aug 2024
- Start date
- 8 Aug 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- SciClone Pharmaceuticals
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06548919
What you commit to
- Study type: Observational
- Planned participants: 450
- From 8 Aug 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 1\. women who are pregnant or breastfeeding
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Haidafu Internet Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.