Status:
COMPLETED
A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant. Patients who have HR positive and HER2 negative recurre...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
- Age: 18 - 75 years old, postmenopausal women.prepostmenopausal women, but should receive Ovary castration.
- Inclusion Criteria
- Cohort 1 and Cohort 2 :No prior systemic anti-cancer therapy for advanced HR+ disease.
- Cohort 3 and Cohort 4 : Patients must satisfy the following criteria for prior therapy:
- a) Progressed after 2 years during treatment of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre- or perimenopausal.
- b)Progressed within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre- or perimenopausal.
- c) Progressed while 6 month after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer if postmenopausal, or prior endocrine treatment for advanced/metastatic breast cancer if pre- or perimenopausal.
- One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy.
- 4\. Eastern Cooperative Oncology Group \[ECOG\] 0-1 Measurable disease as per Response Evaluation Criterion in Solid Tumors\[RECIST\] 1.1
- 5\. Adequate organ and marrow function
- Exclusion Criteria
- Confirmed diagnosis of HER2 positive disease
- Patients who received any endocrine therapy as neo/adjuvant therapy for breast cancer are eligible. If the neo/adjuvant therapy of any endocrine therapy , the disease-free interval must be greater than 12 months from the completion of treatment until study entry.
- Patients who received prior treatment with any CDK4/6 inhibitor, everolimus,fulvestant.
- Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention.
- Has known active central nervous system metastases.
Exclusion
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03481998
Start Date
March 22 2018
End Date
July 30 2022
Last Update
November 21 2023
Active Locations (4)
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1
Ha'erbin Tumor Hospital
Harbin, Heilongjiang, China
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
3
Sir Run Run Shaw Hospital of Zhejiang University
Hangzhou, Zhejiang, China
4
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China