Observing treatment outcomes for Chinese patients with advanced breast cancer and ESR1 mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tianjin Haidafu Internet Hospital
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Chunyang Li
• Email: lichunyang@sciclone.com
• Phone: 86-15216717343

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.