Real World Study on the Efficacy and Safety of Anti-HER2 Therapy

Central South University

Status: Completed

Conditions: HER2-positive Breast Cancer; Breast Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT05367739

Real-HER2

Details and patient eligibility

About

Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs.

Full description

About 30% of breast cancer is human epidermal growth factor receptor-2 (HER2) amplification or overexpression (i.e. HER2 positive). HER2 positive breast cancer is one of the indicators of poor prognosis because of its high risk of invasion and metastasis. Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs including antibody drugs such as trastuzumab and pertuzumab, small-molecule tyrosine kinase inhibitors (TKIs) such as lapatinib, neratinib, and pyrotinib, and antibody-drug conjugates such as trastuzumab deruxtecan (DS-8201) and trastuzumab emtansine (T-DM1).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old, voluntary consent and signed written informed consent.
• ECOG 0~2.
• Diagnosis of locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer.
• At least one measurable disease lesion before treatment.
• Anticipated survival time is longer than three months.
• Pathological and IHC reports for ER, PR, HER2 and Ki67 are available.
• For women with fertility, the pregnancy test before administration was negative, and agreed to take appropriate measures to avoid pregnancy during the study treatment and at least half a year after the end of treatment
• There are traceable medical records during treatment.

Exclusion criteria

• Pregnant or lactating women. Active infection requiring systemic treatment。
• HIV positive
• Suffering from or suspected of suffering from central nervous system diseases.
• Serious heart disease.
• Pulmonary lymphatic involvement leads to pulmonary dysfunction and requires active treatment, including the use of oxygen
• The investigator considered that the patient was not suitable for in this study, with any other situation.