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Real world study for neoadjuvant treatment of Her2 positive breast cancer with Pyrotinib maleate tablets

Real world study for neoadjuvant treatment of Her2 positive breast cancer with Pyrotinib maleate tablets

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026061
Enrollment
Unknown
Registered
2019-09-20
Start date
2019-10-08
Completion date
Unknown
Last updated
2020-04-06

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

Conditions

Her2 positive breast cancer

Interventions

Case series: Pyrotinib combined therapy

Sponsors

The First Affiliated Hospital of Guangxi Medical Universtiy
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed positive expression of HER2 in patients with recurrent/metastatic breast cancer; 2. Patients who agree and are able to pass the ICH test for hormone receptor status; 3. Patients who volunteer to participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Inability to swallow, chronic diarrhea, and intestinal obstruction can affect medication use and absorption; 2. Pregnant and lactating female patients; 3. According to the researcher's judgement,there are serious risks to patient safety or concomitant diseases that affect the completion of the study(Including but not limited to severe hypertension beyond the control of drugs, severe diabetes, active infection, severe heart failure, etc.); 4. The researchers consider the patients are unfit to participate in this study with any other conditions.

Design outcomes

Primary

MeasureTime frame
Pathological complete response rate;

Secondary

MeasureTime frame
ECOG score;vital signs;physical examination;Laboratory inspection index;ECG;ultrasonic cardiogram;Quality of Life;adverse event;National Cancer Institute-Common Toxicity Critera Adverse Event 4.0;

Countries

China

Contacts

Public ContactZeng Jian

The First Affiliated Hospital of Guangxi Medical Universtiy

zengjian125@hotmail.com+86 13978876125

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026