HER2-positive Breast Cancer
Conditions
Brief summary
This study is designed to compare efficacy and safety of GQ1005 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.
Detailed description
This is a phase III, multicenter, open-label, randomized controlled study comparing GQ1005 with Trastuzumab Emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane. Approximately 228 patients with unresectable or metastatic HER2-positive breast cancer will be randomized 1:1 to receive GQ1005 or T-DM1, respectively.
Interventions
DRUGGQ1005
Administered I.V.
DRUGT-DM1
Administered I.V.
Sponsors
GeneQuantum Healthcare (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female adults ≥ 18 years at the time of voluntary signing of informed consent. * Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane * Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1. * Presence of at least one measurable lesion according to RECIST v1.1 * Expected survival time ≥ 12 weeks. * Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study NOTE: Other protocol defined Inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 24 months | — |
| Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1 | Up to approximately 24 months | — |
| Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1 | Up to approximately 24 months | — |
| Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1 | Up to approximately 24 months | — |
| Disease Control Rate (DCR) by BICR and investigator assessment per RECIST 1.1 | Up to approximately 24 months | — |
| Adverse events：Number and percentage of patients who report serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), TEAEs leading to study drug discontinuation, adverse events of special interest (AESIs) (graded according to the Nationa | Up to approximately 24 months | — |
| PK parameters：Plasma concentrations of GQ1005 ADC, total anti-HER2 antibody and free toxin DXd at each time point | Up to approximately 24 months | — |
| Anti-drug antibodies (ADA)：Number and percentage of patients who develop anti-drug antibody (ADA). | Up to approximately 24 months | — |
| Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by EQ-5D-5L | Up to approximately 24 months | Change from baseline in EQ-5D-5L health state utility index score and Visual Analogue Scale (VAS) score. VAS score range from 0-100, higher scores indicate better health status. |
| Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30 | Up to approximately 24 months | Change from baseline in the functioning/symptom/global quality of life (QoL) subscales of EORTC QLQ-C30. Scale scores range from 0-100. For functioning and global QoL scales, higher scores indicate better functioning or global health status. For symptom scales, higher scores indicate greater symptom burden. |
| Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by EORTC QLQ-BR45 | Up to approximately 24 months | Change from baseline in the functioning/symptom subscales of EORTC QLQ-BR45. Scale scores range from 0-100. For functioning scales, higher scores indicate better functioning. For symptom scales, higher scores indicate greater symptom burden. |
Countries
China
Contacts
CONTACTZhenxing Yang
PRINCIPAL_INVESTIGATORZefei Jiang, M.D.
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Outcome results
None listed