RWS of Inetetamab HER2 Positive Advanced Breast Cancer

HER2-positive Advanced Breast Cancer Clinical Trial

Official title:

Real World Study of Inetetamab HER2 Positive Advanced Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04963608
• Other study ID #: RSINETE
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: December 2021

Study information

• Verified date: July 2021
• Source: Shandong Cancer Hospital and Institute
• Contact: Zhiyong yu
• Phone: 86-13355312277
• Email: drzhiyongyu[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This non-Interventional study will describe and analyze the clinical use of Inetetamab in clinical practice in the treatment of HER2 positive advanced breast cancer in the real world.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients with stage IV breast cancer

2. Patients with HER2 positive status

3. Patients that received Inetetamab

4. Patients that began Inetetamab therapy prior to June 30, 2021. Exclusion Criteria: Patients treated with an investigational anticancer agent Inetetamab

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Advanced Breast Cancer

Intervention

Drug:
• Inetetamab
8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhiyong Yu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival(PFS)		12 months
Primary	Incidences of adverse events and toxicities		12 months