Overview

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

Status:
Not yet recruiting
Trial end date:
2022-08-20
Target enrollment:
0
Participant gender:
Female
Summary
The study is being conducted to assess the efficacy and safety of SHR6390 combined with famitinib in the treatment of advanced or metastatic breast cancer that progress in 1-2 line endocrine therapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
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 HR+/HER2- recurrent/metastatic breast
cancer;

5. Participants must not have received more than two prior lines of hormonal therapy;

6. Participants must not have received more than two prior lines of chemotherapy in
recurrence or metastatic setting. In addition, participants must have been treated
with taxanes.

7. 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. Participants must have
experienced disease recurrence or progression during or after last therapy;

8. Adequate function of major organs

9. Participants who have not received anticoagulation therapy: INR≤1.5, APTT≤1.5 ULN.
Participants receiving full-dose or parenteral anticoagulation therapy had a stable
dose of anticoagulant for more than 2 weeks before entering the clinical study, the
result of the coagulation test is within the normal range;

10. Women of childbearing potential who have a negative pregnancy test within 14 months
before enrollment and willing to use adequate contraception prior to enrollment and
for the duration of study participation;

11. No radiotherapy, chemotherapy, molecular targeted therapy, immunotherapy, or surgery
were received within 4 weeks before enrollment, and the toxicity of the previous
treatment has been restored to ≤1 grade (such as surgery, the wound has healed
completely); no endocrine therapy within 7 days before enrollment;

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

Exclusion Criteria:

1. Participants who previously received VEGFR TKI;

2. Participants who previously received CDK4/6 inhibitor;

3. Allergy to study drug or its components;

4. Metastasis history of the central nervous system, or brain imaging at baseline or
clinical evidence suggests the presence of CNS;

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

6. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma ,
skin basal cell carcinoma and squamous-cell carcinoma

7. History of heart disease: uncontrollable hypertension (>140/90 mm Hg), hypertensive
crisis or hypertensive encephalopathy, ≥ Grade II myocardial ischemia or myocardial
infarction, poorly controlled arrhythmia (≥Grade 2, QTc interval ≥470 ms), can't stop
taking drugs that may prolong QT (such as antiarrhythmic drugs) during the study; Ⅲ ~
Ⅳ stage heart failure(according to NYHA), or LVEF <50%;

8. Abnormal coagulation function (INR>1.5 or PT >ULN+4 seconds or APTT>1.5 ULN), have
bleeding or thrombotic tendency or receiving thrombolytic or anticoagulant therapy;

9. A history of bleeding, with clinically significant bleeding symptoms or clear bleeding
tendency within 3 months before enrollment, such as gastrointestinal bleeding,
hemorrhagic gastric ulcer, fecal occult blood ≥++, or vasculitis;

10. Arterial/venous thrombosis occurred within one year before screening;

11. Tumor has invaded important blood vessels or the tumor is likely to invade important
blood vessels and cause fatal hemorrhage during treatment; thyroid function is
abnormal, even treatment cannot maintain normal thyroid function;

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

13. Long-term unhealed wounds or fractures;

14. Received major surgery or suffered severe traumatic injury, fracture or ulcer within 4
weeks after enrollment;

15. Poor absorption of oral drugs, such as inability to swallow, chronic diarrhea and
intestinal obstruction;

16. Active HBV/HCV/HIV infection;

17. Pregnant or breastfeeding women. Women of childbearing potential who have a positive
pregnancy test or unwilling to use adequate contraception prior to enrollment and for
the duration of study participation; Any condition which in the investigator's opinion
makes the subjects unsuitable for the study participation.