NCT06839547 A Prospective, Multicenter, Observational Cohort Study to Evaluate the Efficacy and Safety of a Novel Anti-tumor Drug as a Radiosensitizer in Patients With Advanced Breast Cancer Brain Metastasis.
| NCT ID | NCT06839547 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Advanced Breast Cancer Brain Metastasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2028-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-03-01 with a primary completion date of 2028-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A prospective, multicenter, observational cohort study to evaluate the efficacy and safety of a novel anti-tumor drug as a radiosensitizer in patients with advanced breast cancer brain metastasis.
Eligibility Criteria
Inclusion Criteria: 1. Males or females who are at least 18 years of age on the day of signing the informed consent form. 2. Patients with advanced breast cancer that is inoperable and has metastasized to the brain, confirmed by histology or cytology. 3. Patients who are planned to receive, currently receiving, or have completed intracranial radiotherapy after discussion by a multidisciplinary team (MDT) at the stage of brain metastasis. 4. Patients who are planned or currently receiving a systemic treatment regimen with a novel anti-tumor drug selected by the physician, within 3 weeks before radiotherapy, during radiotherapy, or within 3 weeks after completion of radiotherapy. These drugs include: ADC drugs (such as T-DXd, T-DM1, etc.), CDK4/6 inhibitors, TKI drugs (such as Pyrotinib, Tucatinib, etc.), Novel chemotherapy drugs (such as Utidelone, Irinotecan liposomes, etc.), Bevacizumab, PD-1/PD-L1 inhibitors, etc. 5. Patients with a traceable medical history during the treatment period. 6. Patients who are able to sign the informed consent form to participate in the study. Exclusion Criteria: 1. The subject has leptomeningeal metastasis. 2. If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy. 3. The subject has not signed the informed consent form. 4. Pregnant or breastfeeding women. 5. Other situations deemed by the investigator as unsuitable for inclusion in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06839547 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Breast Cancer Brain Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06839547 currently recruiting?
Yes, NCT06839547 is actively recruiting participants. Contact the research team at drmafei@126.com for enrollment information.
Where is the NCT06839547 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06839547 clinical trial?
NCT06839547 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 100 participants.
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