Trials / Recruiting
RecruitingNCT06341894
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,163 (estimated)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dalpiciclib | CDK4/6 inhibitor dalpiciclib, 100mg orally qd |
| DRUG | Endocrine therapy | Fulvestrant/AI |
Timeline
- Start date
- 2023-11-17
- Primary completion
- 2027-06-01
- Completion
- 2029-06-01
- First posted
- 2024-04-02
- Last updated
- 2024-04-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06341894. Inclusion in this directory is not an endorsement.