RWS of Inetetamab HER2 Positive Advanced Breast Cancer

July 14, 2021 updated by: Zhiyong Yu

Real World Study of Inetetamab HER2 Positive Advanced Breast Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

HER2+ advanced breast cancer patients whose treatment decision with Inetetamab has been made by their physician and who meet the eligibility criteria will be invited to participate in the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival(PFS)
Time Frame: 12 months
12 months
Incidences of adverse events and toxicities
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhiyong Yu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 11, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSINETE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The results of this retrospective observational study will not be formally documented in a Clinical Study Report. Coded patient-level data will be shared with the sponsor.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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