Health TrialsbyHealthPanel

A Real-world Study of Inetetamab for First-line Treatment of MBC

ConditionsBreast CancerReal-world Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHunan Cancer Hospital

About this trial

This is a prospective, multicenter, real-world study aimed at evaluating the efficacy and safety of inetetamab+chemotherapy or inetetamab+pyrotinib+chemotherapy or inetetamab+pertuzumab+chemotherapy in the treatment of HER2 positive inoperable locally advanced or recurrent metastatic breast cancer. The research results will provide new targeted treatment strategies for HER2 positive breast cancer patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥18 years and ≤75 years;Patients aged ≥18 years and ≤75 years;

At least one measurable lesion was present according to RECIST1.1 criteria;

The ECOG score is 0 to 1;

No systematic antitumor therapy (except first-line endocrine therapy) has been received at the locally advanced stage (clinically inoperable) or at the stage of recurrence and metastasis;

Disqualifiers

Known allergic history of drug components of the program;

Patients judged unsuitable for systematic chemotherapy by researchers;

Use of endocrine therapy drugs within 14 days before baseline;

Patients with only bone or skin as target lesions;

Trial population

First-line treatment of HER2 positive inoperable local advanced or recurrent metastatic breast cancer patients.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Inetetamab

    Drug

    Inetetamab-based treatment for first-line treatment of HER2-positive MBC

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Inetetamab1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival

The survival time from the date of randomization to the date of the first documented progression or date of death, whichever came first, assessed up to 60 months

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary outcomes

1

Objective Response Rate

The total rate of CR+PR after the completion of two cycles of treatment.

Time frame
From date of randomization until the date at the end of the second treatment cycle (42 days)
2

Overall survival

The time from randomization to death from any cause

Time frame
The time from randomization to death from any cause, whichever came first, assessed up to 60 months
3

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.

Time frame
The time from randomization to reach the endpoint, assessed up to 60 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hunan Cancer Hospital

Lead sponsor

Hunan Medical University General Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: