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

Breast Neoplasms Clinical Trial

Official title:

A Real-world Observational Study on the Efficacy and Safety of Anti HER2 Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05367739
• Other study ID #: Real-HER2
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2023
• Source: Hunan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 1, 2023
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	The total rate of CR+PR after the completion of two cycles of treatment.	From date of randomization until the date at the end of the second treatment cycle (42 days)
Primary	Progression-Free Survival (PFS)	The survival time from the date of recruitment to the date of the first documented progression or date of death.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Primary	Adverse Events	All adverse events [including adverse events (AE / SAE) and ADR (adverse drug reactions)] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months