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A multicenter, single-arm phase II clinical study of eribulin combined with inituzumab and pyrotinib in the treatment of HER2-positive advanced breast cancer

A multicenter, single-arm phase II clinical study of eribulin combined with inituzumab and pyrotinib in the treatment of HER2-positive advanced breast cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121825
Enrollment
Unknown
Registered
2026-04-03
Start date
2026-03-18
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

breast cancer

Interventions

Test group:Eribulin combined with initumab combined with pyrotinib

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old =55 %; 8. Adequate bone marrow functional reserve: white blood cell count >=3.0×10^9/L, neutrophil count >=1.5×10^9/L; platelet count >=100×10^9/L; hemoglobin >=90g/L; 9. AST and ALT <= 2 times the upper limit of normal value, alkaline phosphatase <= 2 times the upper limit of normal value, total bilirubin <= 2 times the upper limit of normal value; serum creatinine <= 1.5 times the upper limit of normal value; 10. For female patients who are not menopausal or surgically sterilized: consent to contraception during treatment and for at least 7 months after the last dose of study treatment; 11. Voluntarily join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Her-2 or hormone receptor status is unknown; 2. Patients with known allergies to the active ingredient or other components of the study drug; 3. It is judged by the researcher that other anti-tumor treatments are needed during treatment. 4. Those with severe heart disease or discomfort who are expected to be unable to tolerate chemotherapy, including but not limited to: A. Fatal arrhythmia or higher-grade atrioventricular block (second-degree type 2 atrioventricular block or third-degree atrioventricular block); B. Unstable angina; C. Clinically significant valvular heart disease; D. Electrocardiogram showing transmural myocardial infarction; E. Uncontrollable hypertension. 5. Have undergone major surgical operations unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical operations; 6. Serious or uncontrolled infections that may affect study treatment or evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, lung infection, etc.; 7. Have a history of other malignant tumors in the past 5 years (except for cured cervical carcinoma in situ or cutaneous basal cell carcinoma, etc.); 8. People with basic gastrointestinal diseases (especially a history of long-term diarrhea and constipation), inability to swallow, intestinal obstruction, or other factors that affect drug taking and absorption; 9. The investigator believes that the patient has any other condition that makes him/her unfit to participate in the study.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Secondary

MeasureTime frame
Progression-Free Survival;Safety evaluation;Overall Survival;

Countries

China

Contacts

Public ContactPeng Peijian

Fifth Affiliated Hospital, Sun Yat-Sen University

pengpjian@163.com+86 756 252 8015

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026