Trials / Not Yet Recruiting
Not Yet RecruitingNCT05841381
Adjuvant Study of Pyrotinib in Combination With Trastuzumab in HER2 Positive Invasive Breast Cancer
Adjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive and Lymph Node Negative Invasive Breast Cancer
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 876 (estimated)
- Sponsor
- Fudan University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label, phase III study evaluating the efficacy and safety of Pyrotinib in Combination With Trastuzumab and paclitaxel in patients HER2 Positive and lymph node negative invasive Breast Cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pyrotinib | pyrotinib: 400mg orally daily for 1 year |
| DRUG | Trastuzumab | 8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 17 cycles |
| DRUG | Paclitaxel | 80mg/m2 per week for a total of 12 weeks |
Timeline
- Start date
- 2023-05-06
- Primary completion
- 2028-05-06
- Completion
- 2033-05-06
- First posted
- 2023-05-03
- Last updated
- 2023-05-03
Source: ClinicalTrials.gov record NCT05841381. Inclusion in this directory is not an endorsement.