Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of HR-positive, HER2-negative Advanced Breast Cancer
NCT ID: NCT05176080
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
46 participants
INTERVENTIONAL
2021-12-08
2024-07-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
Famitinib Plus SHR6390 and Endocrine therapy
Famitinib
Famitinib orally, daily or every other day
SHR6390
SHR6390 orally, daily for 3 weeks followed by 1 week off
Fulvestrant
Fulvestrant
Interventions
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Famitinib
Famitinib orally, daily or every other day
SHR6390
SHR6390 orally, daily for 3 weeks followed by 1 week off
Fulvestrant
Fulvestrant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HR-positive, HER2- negative breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
* Ib: Patients who received no more than 2 line of chemotherapy in advanced setting were recruited; II: Patients who had not received any chemotherapy and no more than 1 line of endocrine therapy.
* 18-75 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status 0～1.
* life expectancy is not less than 12 weeks.
* at least one measurable lesion according to RECIST 1.1.
* Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L, Platelets ≥90×10\^9/L, Hemoglobin ≥ 90 g/L; Total bilirubin≤1.5 upper limit of normal (ULN)；Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN (ALT and AST≤5×ULN if liver metastasis); blood urea nitrogen (BUN) and Creatinine (Cr)≤1.5×ULN
* Left ventricular ejection fraction (LVEF) ≥ 50% and QTc≤470 ms
Exclusion Criteria
* Ib: Patients who had symptomatic brain metastasis; II: Patients who had brain metastasis;
* Patients unsuitable for endocrine therapy;
* Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
* Participated in other drug clinical trials within 4 weeks before admission
* Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
* Active human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
* Has suffered from any heart disease
* Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
* According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
* Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever（\> 38.5 ℃） of unknown origin occurs during the screening period/before the first administration.
* Researchers believe that patients are unsuitable for any other situation in this study.
18 Years
75 Years
FEMALE
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Min Yan
Role: PRINCIPAL_INVESTIGATOR
Henan Cancer Hospital
Locations
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Henan Cancer Hospital
Zhengzhou, Henan, China
Countries
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Other Identifiers
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BC-IIT-FMTN-SHR6390-ET
Identifier Type: -
Identifier Source: org_study_id