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

NCT ID: NCT05367739

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2023-07-01

Brief Summary

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.

Detailed 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).

Conditions

Breast Neoplasms; HER2-positive Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hunan Cancer Hospital

Changsha, Hunan, China

Countries

China

Other Identifiers

Real-HER2

Identifier Type: -

Identifier Source: org_study_id