Trials / Unknown
UnknownNCT04385563
A Study to Evaluate the Efficacy and Safety of the Combination of TQ-B211 Plus Docetaxel in Patients With HER2-positive MBC.
A Phase III,Randomized,Multicenter,Double-blind Clinical Trail to Evaluate the Efficacy,Safety and Immunogenicity of the Combination of TQ-B211 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First-line Treatment in Patients With HER2-positive MBC.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 338 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy,safety and immunogenicity of TQ-B211 plus docetaxel versus Herceptin® plus docetaxel in Patients with HER2-positive metastatic breast cancer.Trastuzumab plus docetaxel was chosen as the comparator in the control group,as it represents a common first-line treatment option used in HER2+ MBC population in China.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TQ-B211 | Participants will receive TQ-B211 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8. |
| DRUG | Herceptin® | Participants will receive Herceptin® 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8. |
| DRUG | docetaxel | Participants will receive docetaxel 75 milligrams/square meter (mg/m\^2) iv.on day 2 in Cycle 1 followed by 75mg/m\^2 iv.on day 1 in Cycles 2 to 8. |
Timeline
- Start date
- 2018-11-11
- Primary completion
- 2021-02-01
- Completion
- 2021-10-01
- First posted
- 2020-05-13
- Last updated
- 2020-05-13
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04385563. Inclusion in this directory is not an endorsement.