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

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

Research endpoint:

Main research endpoint:

Progression free survival (rwPFS)

Secondary study endpoint:

Efficacy endpoints: objective response rate (rwORR), disease control rate (rwDCR), until treatment failure Time to Flight (TTF), Total Survival (OS), Security

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Pyrotinib; RWS
• Intervention / Treatment: Drug: Pyrotinib

Detailed Description

Overall Study Design: This study adopts a prospective, multicenter, and observational design, with a planned enrollment of 500 first-line patients who plan to receive pyrrolitinib treatment for HER2 positive patients. The medication regimen is not restricted, Fully follow the clinical choices of doctors and evaluate the clinical benefits of using different modes of pyrrolitinib (PFS) and security. The imaging evaluation is based on the RECIST 1.1 standard and is conducted by reference to the The research center conducts tumor efficacy evaluation. Patients using pyrrolitinib need to undergo a safety visit on the 28th day of the last administration, and thereafter Enter survival follow-up until patient death or trial termination (whichever occurs first).

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.

Inclusion criteria:

1. Age ≥ 18 years old;
2. 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);
3. There is a traceable medical history record during the treatment period;
4. Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate Follow up.

Exclusion criteria:

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

Research principle: In the first-line treatment of HER2 positive breast cancer with pyrrolitinib, trastuzumab and docetaxel, the median PFS assessed by the investigator as the primary endpoint was 24.3 months, and the ORR was 88%.

Approved by the National Medical Products Administration (NMPA) for HER2 positive in April 2023 First line treatment of sexual breast cancer and all indications of pyrrolidine will be covered by medical insurance in 2024 Cover. Pyrrolitinib is currently registered for research and development in neoadjuvant, adjuvant, and advanced stages The research is currently underway, all of which are RCT studies, but there is currently no real-world data available I hope to further verify the efficacy of pyrrolitinib in treating HER2 positive advanced first-line breast cancer in the real world The efficacy and safety of adenocarcinoma.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xuejing liu; Phone Number: 19502151516; Email: lxj8109@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years old;
2. 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);
3. There is a traceable medical history record during the treatment period;
4. Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate Follow up.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pyrotinib	Drug: Pyrotinib; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	The time from randomization to disease progression evaluated by researchers for patients	24.3months

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; pyrotinib
• Other Study ID Numbers: Tianjin Cancer Hospital..

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No