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Pyrotinib in T-DXD-treated HER2-positive advanced breast cancer: a prospective, single-arm, multicenter, real-world study

Pyrotinib in T-DXD-treated HER2-positive advanced breast cancer: a prospective, single-arm, multicenter, real-world study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096763
Enrollment
Unknown
Registered
2025-02-06
Start date
2025-02-21
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Locally advanced breast cancer and recurrent or metastatic breast cancer

Interventions

Treatment group:Pyrotinib in combination with chemotherapy

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years old; 2.Patients must have pathologically confirmed advanced breast cancer, including locally advanced breast cancer and recurrent or metastatic breast cancer. Locally advanced breast cancer includes stage III B and III C breast cancer with skin, chest wall or regional lymph node involvement that is difficult to undergo radical surgery. 3.After local assessment and confirmed by pathology as HER2 positive (IHC 3+ or ISH+); 4.Only T-DXd is accepted as the first-line or second-line treatment for advanced breast cancer, and after progression on T-DXd, the plan is to receive pyrotinib in combination with chemotherapy.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women; 2.Not having signed the informed consent form; 3.Incomplete clinical data; 4.Currently engaged in other research. 5.The researchers believe that the patient is not suitable for participating in this study under any other circumstances, such as concurrent non-tumor diseases that affect the anti-tumor treatment.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Objective response rate;Objective response rate;

Countries

China

Contacts

Public ContactZheng Lv

The First Hospital of Jilin University

lvz@jlu.edu.cn+86 15804301705

Outcome results

None listed

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