Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05629949 | A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer | PHASE3 | COMPLETED | 474 | — | — | Apr 29, 2020 | Apr 13, 2023 | Apr 23, 2024 | 1 | China |
calculated as the proportion of patients with a best response of complete response (CR) or partial response (PR) from first assessment until Week 24 according to RECIST 1.1.
| Arm | Type | Description |
|---|---|---|
| QL1701+Docetaxel | EXPERIMENTAL | Participants received intravenous infusion of QL1701 with docetaxel. The initial load dose of QL1701 was 8mg/kg, followed by 6mg/kg every three weeks; The recommended dose of docetaxel is 75mg/m2, given once every 3 weeks for a treatment cycle of 3 weeks. |
| Herceptin®+Docetaxel | ACTIVE_COMPARATOR | Participants received intravenous infusion of Herceptin® with docetaxel. The initial load dose of Herceptin® was 8mg/kg, followed by 6mg/kg every three weeks; The recommended dose of docetaxel is 75mg/m2, given once every 3 weeks for a treatment cycle of 3 weeks. |
| Name | Type | Description |
|---|---|---|
| QL1701 | DRUG | 8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles. |
| Herceptin® | DRUG | 8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles. |
| Docetaxel | DRUG | The recommended dose is 75mg/m2 and the infusion time is approximately 70min (±20min) (or adjusted according to clinical experience at each study center). The drug was administered once every 3 weeks for a treatment cycle of 3 weeks, with the exception of the second day of the first cycle, followed by the first day of each cycle for at least 8 cycles |
Inclusion Criteria: 1. Patients have voluntarily agreed to participate and given written informed consent. 2. Female ≥18 years of age on day of signing the informed consent form (ICF). 3. Histologically or cytologically confirmed adenocarcinoma of the breast that is HER2-positive by molecular patho...