Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer
Recruiting
Phase 2Interventional Study
Breast CancerAdvanced Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
265 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a randomized, controlled, open-label, phase II study to explore the efficacy and safety of Everolimus in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF1 subtype of advanced breast cancer. The study was used to explore the efficacy of Everolimus in combination with standard endocrine therapy.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Patients need to meet all of the following conditions
* 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);
* SNF1 subtype definition: SNF1 …
Inclusion Criteria:
* Patients need to meet all of the following conditions
* 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);
* SNF1 subtype definition: SNF1 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 any of the following conditions were excluded from the study
* 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 prior to 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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.