Trials / Active Not Recruiting
Active Not RecruitingNCT05165225
Phase II Neoadjuvant Pyrotinib Combined with Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-arm, prospective, non-randomized, single-center, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib combined with epirubicin and cyclophosphamide followed by docetaxel in HR positive and HER2-low-expressing early or locally advanced breast cancer.
Conditions
- Breast Cancer
- HER2-low-expressing Breast Cancer
- Hormone Receptor-positive Breast Cancer
- Neoadjuvant Therapy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment | Drug: Pyrotinib pyrotinib 320mg orally daily Drug: Epirubicin epirubicin 90mg/m\^2 d1 iv Q3W for 4 cycles Drug: Cyclophosphamide cyclophosphamide 600mg/m\^2 d1 iv Q3W for 4 cycles Drug: Docetaxel docetaxel 100mg/m\^2 d1 iv Q3W for 4 cycles |
Timeline
- Start date
- 2021-07-13
- Primary completion
- 2023-09-30
- Completion
- 2028-03-31
- First posted
- 2021-12-21
- Last updated
- 2024-11-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05165225. Inclusion in this directory is not an endorsement.