Trials / Unknown
UnknownNCT04236310
A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER+/HER2+ Breast Cancer.
A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER-Positive, HER2-Positive Breast Cancer.
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- Sponsor
- Ruijin Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of the SHR6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with ER-positive, HER2-positive breast cancer in the neoadjuvant setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR6390 | SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment for 4 cycles |
| DRUG | Anastrozole | Anastrozole 1md, orally once daily for 16 weeks (For premenopausal women, ovarian suppression may be considered) |
| DRUG | Pyrotinib | Pyrotinib 400mg once daily for 16 weeks |
| DRUG | Trastuzumab | Trastuzumab 6mg/kg (loading dose, 8mg/kg), infusion once every 3-week cycle for 5 cycles. |
Timeline
- Start date
- 2020-01-15
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2020-01-22
- Last updated
- 2020-01-22
Source: ClinicalTrials.gov record NCT04236310. Inclusion in this directory is not an endorsement.