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Efficacy and safety of DEBTACE combined with endocrine therapy in the treatment of luminal breast cancer liver metastasis

Efficacy and safety of DEBTACE combined with endocrine therapy in the treatment of luminal breast cancer liver metastasis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041979
Enrollment
Unknown
Registered
2021-01-10
Start date
2021-01-07
Completion date
Unknown
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer liver metastasis

Interventions

experimental group:DEBTACE+ endocrine therapy
control group:endocrine therapy

Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. According to the "Guidelines and Standards for the Diagnosis and Treatment of Breast Cancer of the Chinese Anti-Cancer Association (2019 Edition)", a clear diagnosis of luminal breast cancer with liver metastasis. 3. Pathologically confirmed HER2-negative breast cancer. 4. ECOG (Eastern Cooperative Oncology Group of the United States) physical status score 0-1 points. 5. Liver function Child-Pugh grade A or better grade B (<= 7 points) 6. The liver has at least one measurable target lesion required by RECIST 1.1; 7. The expected survival time is greater than 3 months; 8. The patient voluntarily joined the study and signed an informed consent form (ICF); 9. Those who are expected to have good compliance can follow up the efficacy and adverse reactions as required by the plan.

Exclusion criteria

Exclusion criteria: 1. Triple negative breast cancer; 2. There is severe liver and kidney dysfunction; 3. There are obvious contraindications for interventional therapy: those with obvious arteriovenous fistula; uncorrectable coagulation dysfunction and obvious abnormal blood picture, and those with obvious bleeding tendency; intractable large amounts of ascites; 4. Combined with active infection, especially inflammation of the biliary system; 5. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire test period; 6. According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, etc.); 7. The researcher believes that the patient is not suitable to participate in any other situations in this research.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactLiu Jibing

Shandong Cancer Hospital

13021710539@163.com+86 13021710539

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026