A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer

NCT ID: NCT05103826

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2023-06-15

Brief Summary

The study is being conducted to assess the safety 、tolerability 、 pharmacokinetics and efficacy of SHR6390 combined with famitinib in the treatment of ER + / HER2- advanced breast cancer.

Conditions

ER+ / HER2- Advanced Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR6390+famitinib

Participants will receive SHR6390 in combination with famitinib.

Group Type: EXPERIMENTAL

SHR6390、Famitinib

Intervention Type: DRUG

SHR6390, oral;Famitinib, oral.

Interventions

SHR6390、Famitinib

SHR6390, oral;Famitinib, oral.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Female subjects aged 18 to 75 years old；

2. ECOG performance status 0-1;

3. Life expectancy is not less than 12 weeks;

4. Histological or cytological confirmation of ER+/HER2- recurrent/metastatic breast cancer;

5. Participants with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST1.1;

6. Adequate function of major organs;

7. Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.

Exclusion Criteria

1. Confirmed diagnosis of HER2 positive disease;

2. Participants who previously received SHR6390 or VEGFR inhibitors;

3. Allergy to study drug or its components;

4. Participated in other drug clinical trials within 4 weeks before the first dose;

5. Other malignancies within 3 years, except cured non-melanoma skin cancer , skin basal cell carcinoma and squamous-cell carcinoma or carcinoma in situ of the cervix;

6. 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；

7. Tumor has invaded important blood vessels or the tumor is likely to invade important blood vessels and cause fatal hemorrhage during treatment;

8. Urine routine test indicates urine protein ≥(++), or 24-hour urine protein >1.0g;

9. Active HBV/HCV/HIV infection;

10. The investigators determined that other conditions were inappropriate for participation in this clinical trial；

11. Pregnant or breast-feeding women;

12. Central nervous system (CNS) invasion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Countries

China

Other Identifiers

SHR6390-SHR1020-I-101-BC

Identifier Type: -

Identifier Source: org_study_id