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A multicenter, exploratory study of Eribulin combined with Pyrotinib in patients with advanced HER2-positive breast cancer who have previously used Taxanes and are resistant to Herceptin

A multicenter, exploratory study of Eribulin combined with Pyrotinib in patients with advanced HER2-positive breast cancer who have previously used Taxanes and are resistant to Herceptin

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038832
Enrollment
Unknown
Registered
2020-10-05
Start date
2020-09-30
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Breast cancer

Interventions

Single-arm:Eribulin combine Pyrotinib

Sponsors

The Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged >= 18 years and = 70 points; (5) Sufficient bone marrow functional reserve: total number of white blood cells > 4.0 x 10^9/L, neutrophils > 2.0 x 10^9/L; platelets > 100 x 10^9/L; hemoglobin > 90 g/L; (6) Sufficient kidney function reserve: serum creatinine 44-133 µmol/L; (7) Sufficient liver function reserve: AST and ALT = 50%; (9) Expected survival period >= 12 months; (10) The pregnancy test for women of childbearing age must be negative; (11) Volunteer to join the study, sign an informed consent form, have good compliance and are willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: (1) New York Heart Association (NYHA) scores to identify heart disease patients above grade II (including grade II); (2) Severe systemic infection; (3) Known allergy or intolerance to eribulin, pyrotinib or its excipients; (4) Have used any experimental drugs, received radiotherapy, or other chemotherapeutic drugs within 30 days before the first dose of study drug was administered; (5) Pregnant or lactating women, or become pregnant during the study period or within one year after the last use of the study drug; (6) Any situation that the investigator believes to participate in the trial is not in the subjects' best interests (for example, endangering their health) or that would hinder the evaluation of the trial program.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Objective response rate;Duration of remission;Overall survival;Safety;

Countries

China

Contacts

Public ContactZhenchuan Song

The Fourth Hospital of Hebei Medical University

songzhch@hotmail.com+86 13739745699

Outcome results

None listed

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