Tianjin Haidafu Internet Hospital
Suzhou, Jiangsu, China
Location status: Recruiting
NCT Number: NCT06548919
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Suzhou, Jiangsu, China
Location status: Recruiting
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All endocrine treatment regimens approved for advanced breast cancer, including tamoxifen, aromatase inhibitors, fulvestrant, etc.
All chemotherapy treatment regimens approved for advanced breast cancer
Time frame: 18 months
Progression-free survival
Time frame: 6 months
Objective response rate
Time frame: 6 months
Clinical benefit rate
Time frame: 18 months
Duration of response
Time frame: 18 months
Percentage of occurrences of adverse events
Time frame: 18 months
Percentage of occurrences of serious adverse events
Time frame: 18 months
Proportion of endocrine therapy, endocrine-targeted combination therapy or chemotherapy
Time frame: 18 months
proportion of days covered
Contact information is provided by the study sponsor or research team.
SciClone Pharmaceuticals
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06382948
Advanced Breast Cancer, ER-positive Breast Cancer
Innsbruck, Austria
View Trial DetailsNCT06544577
Advanced Breast Cancer, ESR1 Gene Mutation
Qionghai, Hainan, China
View Trial DetailsNCT04174352
ERα+ Breast Cancer, ESR1 Gene Mutation
Madison, Wisconsin, United States
View Trial DetailsNCT07222215
Breast Cancer, Breast Diseases
Boston, Massachusetts, United States
View Trial Details