Overview
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.
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.
Eligibility
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.
Exclusion Criteria:
- Prior anti-HER2 ADC therapy.
- Previous history of interstitial lung disease/noninfectious pneumonitis/radiation pneumonitis requiring steroid therapy.
- Known serious hypersensitivity to the active ingredients of the study drug, inactive ingredients in the formulation, or other antibody drugs.
- Multiple primary malignancies within 3 years, except for adequately resected non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast cancer
- Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension, or other systemic disease that makes compliance with study procedures difficult
- Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.
