RWS of Inetetamab HER2 Positive Advanced Breast Cancer

• Sponsor: Zhiyong Yu (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04963608
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HER2-positive Advanced Breast Cancer	Drug: Inetetamab

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Real World Study of Inetetamab HER2 Positive Advanced Breast Cancer
• Anticipated Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
non-interventional study Her2 positive ABC patients who have received Inetetamab in the metastatic setting.	Drug: Inetetamab; 8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival(PFS) [12 months]

2. Incidences of adverse events and toxicities [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zhiyong Yu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhiyong Yu, Chief of breast department, Shandong Cancer Hospital and Institute
• ClinicalTrials.gov Identifier: NCT04963608
• Other Study ID Numbers: RSINETE
• First Posted: Jul 15, 2021
• Last Update Posted: Jul 15, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jul 15, 2021