Timing ctDNA Testing to Guide Treatment in Advanced Breast Cancer

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 is a multicenter, prospective observational study enrolling 400 adults with histologically confirmed advanced breast cancer. Blood samples will be taken for ctDNA sequencing, and results will inform clinicians who make treatment decisions in routine practice. Patients will have imaging every 8–12 weeks to monitor response, and data on baseline characteristics, treatments, and outcomes will be collected. The primary endpoint is overall survival, with secondary endpoints including progression-free survival and response rate, along with analyses of how ctDNA features correlate with outcomes. Real-world, non-interventional methods will be used, with analyses planned according to intention-to-treat principles and standard statistical models.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed advanced breast cancer
* Age ≥18 years
* Expected survival \>3 months
* Willing to undergo ctDNA testing and sign informed consent form

Exclusion Criteria:

* The subject has not signed the informed consent form.
* Pregnant or breastfeeding women.
* Other situations deemed by the investigator as unsuitable for inclusion in the study.

Where it's running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Study coordinator: Fei Ma, MD
• Email: drmafei@126.com
• Phone: +8615010127581

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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.