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Pyrotinib as neoadjuvant treatment for HER2-positive breast cancer

Pyrotinib as neoadjuvant treatment for HER2-positive breast cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062936
Enrollment
Unknown
Registered
2022-08-24
Start date
2022-09-30
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Breast cancer

Interventions

Experimental group:Pyrotinib-based regimen

Sponsors

the first affiliated hospital with nanjing medical university
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Subjects enrolled in this study must meet all of the following inclusion criteria: 1.Age >=18 years old; 2.Pathologically or histologically confirmed HER2-positive breast cancer patients; 3.Plan to receive neoadjuvant pyrotinib; 4.Voluntarily join the study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: Excluded patients with one of the following conditions: 1.Major surgery unrelated to breast cancer within 4 weeks prior to randomization, or such surgery that has not fully recovered; 2.Pregnant or lactating female patients, female patients with a positive baseline pregnancy test, or fertile patients who are unwilling to take effective contraceptive measures throughout the trial period and within 7 months after the last dose; 3.Serious comorbidities or other comorbidities that would interfere with planned treatment, or any other condition in which the patient is considered unsuitable for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Pathologic Complete Response;

Secondary

MeasureTime frame
Distant Metastasis-Free Survival;Objective Response Rate;Overall survival;safety;

Countries

China

Contacts

Public ContactShui Wang
jintingting0228@126.com025-83714511

Outcome results

None listed

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