Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
NCT ID: NCT06447623
Last Updated: 2024-06-07
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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RECRUITING
PHASE3
184 participants
INTERVENTIONAL
2024-02-01
2029-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm-A
Apatinib combined with cdk4/6i and Endocrine therapy.
Apatinib
Apatinib is a kind of TKI inhibitor.
CDK4/6 Inhibitor
Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.
Aromatase inhibitor and Fulvestrant
Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.
Arm-B
cdk4/6i and Endocrine therapy.
CDK4/6 Inhibitor
Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.
Aromatase inhibitor and Fulvestrant
Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.
Interventions
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Apatinib
Apatinib is a kind of TKI inhibitor.
CDK4/6 Inhibitor
Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.
Aromatase inhibitor and Fulvestrant
Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.
Eligibility Criteria
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Inclusion Criteria
* Patients must be ≥18 and ≤ 75 years of age;
* Pathologically confirmed breast cancer is HR+/HER2- breast cancer (IHC ER \>10%, or/and PR\>10%, HER 0 OR +, if HER2++, FISH negative);
* SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H\&E sections;
* Locally advanced breast cancer (radical local therapy is not possible) or metastatic breast cancer (without using adjuvant CDK4/6 inhibitors in the past, or one year after adjuvant CDK4/6 inhibitor therapy has ended);
* No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer;
* Patients with at least one measurable lesion that has not previously received radiation therapy and can be evaluated repeatedly according to RECIST 1.1;
* The functions of the main organs are basically normal, and the following conditions are met:
1. Blood routine examination standards should meet: HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L; PLT≥75×109/L;
2. Biochemical examination shall meet the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN; Serum Cr ≤1.5×ULN, endogenous creatinine clearance \> 50ml/min (Cockcroft-Gault formula);
* ECOG performance status 0 or 1; The expected survival is more than 3 months;
* Fertile female is required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug;
* Patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up.
Exclusion Criteria
* Patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol).
* A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
* Radiotherapy, chemotherapy, surgery, other targeted therapy, and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks before the first administration of drugs used in this study.
* Pregnant or lactating patients;
* Other malignancies within the previous 3 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ;
* Significant comorbid medical conditions, including mental illnesses that the investigator or sponsor believes would adversely affect the patient\'s participation in the study;
* Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
* The investigator does not consider the patient suitable for participation in any other circumstances of the study.
18 Years
75 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhimin Shao
Director of General Surgery of Fudan Shanghai Cancer Center
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SCHBCC-N068
Identifier Type: -
Identifier Source: org_study_id
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