The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive

NCT06495541 | Not Yet Recruiting

• 1 other identifier: Tianjin Cancer Hospital..
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Research object：Planned to receive pyrrolidine for HER2 positive first-line breast cancer patients Research purpose: Main research objectives: To observe the efficacy and safety of pyrrolidine in the treatment of HER2 positive advanced first-line breast cancer. Secondary research objectives:

1. 1.Evaluate the correlation between patient characteristics in the late stage of treatment and specific treatment plans and clinical outcomes Sex (including safety outcomes)
2. 2.Evaluate whether and how previous anti HER2 therapy affects the efficacy of subsequent pyrrolitinib treatment
3. 3.To observe the efficacy of pyrrolitinib in patients with brain metastasis of HER2 positive breast cancer

Conditions

Breast Cancer; RWS; Pyrotinib

Outcome Measures

Primary Outcomes (1)

• PFS

  The time from randomization to disease progression evaluated by researchers for patients

  24.3months

Study Arms (1)

Pyrotinib

OTHER

Drug: Pyrotinib

Interventions

Pyrotinib DRUG

Administration method: Pyrrolitinib standard dose: 400 mg once a day, oral administration within 30 minutes after breakfast, continuous administration for 21 days per cycle. The dosage can be determined by the doctor according to the actual situation Make adjustments. Other medications: The doctor selects the medication plan based on the actual situation.

Pyrotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old;
• Pathological or histopathological confirmed HER2 positive cases cannot be surgically advanced or metastasized Patients with sexual breast cancer (HER2 positive is defined as: standard immunohistochemistry (IHC) Detected as 3+or ISH positive);
• There is a traceable medical history record during the treatment period;
• Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate Follow up.

You may not qualify if:

• Failure to sign informed consent form;
• Previous history of other malignant tumors, but cured skin basal cell carcinoma and cervical cancer Excluding cancer;
• Difficulty in swallowing, chronic diarrhea, and intestinal obstruction, which can affect medication administration and absorption Various factors;
• Pregnant or lactating women, and women of childbearing age who cannot achieve optimal contraception;
• Any other circumstances in which the researcher deems the patient unsuitable to participate in this study.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

xuejing liu

CONTACT

19502151516; lxj8109@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 10, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-02