Actively Recruiting
Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer
Led by Fudan University · Updated on 2024-02-08
265
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be female and between 18 and 75 years old
- Pathologically confirmed HR+/HER2- breast cancer (ER >10% or PR >10%, HER0 or +, or HER2++ with negative FISH)
- SNF1 subtype confirmed by digital pathology of H&E sections
- Locally advanced breast cancer not suitable for radical surgery or metastatic breast cancer without prior or recent CDK4/6 inhibitor use
- No prior therapy for advanced or metastatic breast cancer
- At least one measurable lesion not previously treated with radiation, evaluable by RECIST 1.1
- Normal main organ functions, meeting blood and biochemical test standards
- ECOG performance status of 0 or 1 with expected survival over 3 months
- Fertile females must use medically approved contraception during treatment and for 3 months after
- Voluntary participation with signed informed consent and ability to comply with follow-up
You will not qualify if you...
- Uncontrolled central nervous system metastases requiring glucocorticoids or mannitol
- History of significant or uncontrolled heart disease including recent myocardial infarction or arrhythmia
- Radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 4 weeks before study drug administration
- Pregnant or breastfeeding women
- Other malignancies within the past 3 years, except cured skin basal cell carcinoma or cervical carcinoma in situ
- Significant medical or mental conditions affecting study participation
- Known allergies to study drug components or related monoclonal antibodies
- Investigator judgment deeming patient unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, MD, PhD
CONTACT
M
Min He, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here