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Outcome Measures

Primary Outcomes (1)

Progression-free survival (PFS)
Independent Imaging Review Committee (IRC)-assessed PFS
Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years

Secondary Outcomes (10)

PFS assessed by Investigator
Baseline up to Investigator-Assessed investigator, approximately 1 years
Overall survival (OS)
From date of the first dose until the date of death from any cause, up to approximately 2 years
Duration of Response (DOR)
From date of the first dose until the date of first documented progression or date of death from any cause, up to approximately 2 years
Proportion of subjects achieving partial response (PR)
From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years
Objective Response Rate (ORR)
From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years
+5 more secondary outcomes

Study Arms (2)

TQB2930+ chemotherapy

EXPERIMENTAL

Subjects will receive TQB2930 injection in combination with chemotherapy agents on Day 1 (D1) of each cycle. TQB2930 will be administered at a dose of 30 mg/kg every 3 weeks (Q3W), Each treatment cycle lasts 21 days.

Drug: TQB2930+ chemotherapy

Trastuzumab+ chemotherapy

ACTIVE COMPARATOR

Subjects will receive trastuzumab in combination with chemotherapy agents on Day 1 (D1) of each cycle. The initial dose of trastuzumab is 8 mg/kg, followed by a maintenance dose of 6 mg/kg administered every 3 weeks (Q3W), Each treatment cycle lasts 21 days.

Drug: Trastuzumab+ chemotherapy

Interventions

TQB2930+ chemotherapyDrug

TQB2930 injection is a HER2 bispecific antibody drug； Chemotherapy: Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.

TQB2930+ chemotherapy

Trastuzumab+ chemotherapyDrug

Trastuzumab is a HER2-specific targeted drug； Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects voluntarily participate in this study and sign the informed consent form;
Age: 18-75 years (at time of signing Informed Consent Form (ICF); Eastern Cooperative Oncology Group (ECOG) performance status ≤1; estimated life expectancy \>3 months;

Study Sites (75)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233060, China

NOT_YET_RECRUITING

Mingliang Zhang, MasterCONTACT13855269689 19257387@qq.com

Anhui Provincial Hospital( The First Affiliated Hospital of USTC)

Hefei, Anhui, 230001, China

NOT_YET_RECRUITING

Nannan Lu, DoctorCONTACT18130056850

TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

TQB2930+ chemotherapy

Trastuzumab+ chemotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (75)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

TQB2930+ chemotherapy

Trastuzumab+ chemotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (75)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations