Status:
COMPLETED
Real World Study on the Efficacy and Safety of Anti-HER2 Therapy
Lead Sponsor:
Hunan Cancer Hospital
Conditions:
Breast Neoplasms
HER2-positive Breast Cancer
Eligibility:
All Genders
18+ years
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 prognos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05367739
Start Date
June 1 2020
End Date
July 1 2023
Last Update
September 7 2023
Active Locations (1)
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1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013