Status:
UNKNOWN
A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 ne...
Eligibility Criteria
Inclusion
- Has the pathologically-confirmed diagnosis of locally advanced, recurrent or metastatic, HR positive, HER2 negative Breast Cancer
- One previous line of chemotherapy for advanced/metastatic disease is allowed
- Disease Progression following endocrine therapy
- Have postmenopausal status
- Have 1 of the following, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: measurable disease or nonmeasurable bone-only disease
- ECOG: 0\~1
- Adequate organ function
Exclusion
- Previous treatment with cytotoxic drugs within 4 weeks before enrollment
- Previous treatment with endocrine or small molecule drug tyrosine kinase inhibitor TKI within 2 weeks before enrollment
- Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant
- HER2 positive
- Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, etc
- Pregnancy or lactation
- Other conditions considered not appropriate to participate in this trial by the investigators
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT05433480
Start Date
May 25 2022
End Date
July 31 2025
Last Update
July 27 2023
Active Locations (64)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233099
2
Anhui Provincial Hospital
Hefei, Anhui, China, 230002
3
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
4
The First Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, China, 100039