Actively Recruiting
Everolimus With Investigator's Choice of Chemotherapy Versus Chemotherapy for First-Line Treatment of LAR Subtype with PAM Mutation in Advanced Triple-Negative Breast Cancer
Led by Fudan University · Updated on 2024-01-16
203
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial studies women with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) of the luminal androgen receptor (LAR) subtype with a specific mutation in the PI3K/AKT/mTOR (PAM) pathway. It evaluates whether combining everolimus with an investigator's choice of chemotherapy improves outcomes as a first-line treatment, compared to chemotherapy alone. The study also assesses the impact on patients' quality of life. Participants will be randomly assigned to receive either everolimus plus one of several chemotherapy options (nab-paclitaxel, capecitabine, eribulin, carboplatin, vinorelbine, or utidelone) or chemotherapy alone. Treatment is given under medical supervision and aims to compare progression-free survival and overall survival between these groups. This is an open-label, phase III study. During approximately three years, participants will undergo regular scans (CT/MRI) to evaluate tumor response and progression. Researchers will monitor survival, treatment safety, side effects, and patient-reported outcomes related to quality of life. Organ function and laboratory tests will be checked to ensure participant safety and treatment tolerance throughout the study.
CONDITIONS
Brief Title
Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- ECOG performance status 0 or 1
- Expected survival longer than 3 months
- Pathologically confirmed triple-negative breast cancer with LAR subtype and PAM pathway mutation
- Locally recurrent inoperable or metastatic breast cancer
- No prior chemotherapy or targeted therapy for advanced/metastatic breast cancer
- At least one lesion evaluable by CT/MRI per RECIST 1.1
- Normal organ function meeting specified blood and biochemical criteria
- No radiotherapy, endocrine therapy, targeted therapy, or surgery within 3 weeks before study start
- Fertile females agree to use medically approved contraception during and for 3 months after treatment
- Voluntary informed consent and ability to comply with study follow-up
You will not qualify if you...
- Known or suspected central nervous system metastasis
- Significant or uncontrolled heart disease within 6 months
- Persistent grade 1 or higher adverse events from prior treatments (except hair loss)
- Major surgery within 3 weeks before trial treatment (minor outpatient surgery allowed)
- Pregnant or breastfeeding
- Other malignancies within 5 years except certain skin or cervical cancers
- Inability to swallow or absorb drugs properly
- Uncontrolled third space effusions like pleural fluid or ascites
- Participation in other anti-tumor drug trials within 4 weeks prior to study drug
- Long-term unhealed wounds or fractures
- Active hepatitis B or C infection with abnormal liver function
- Known allergies to study drugs or monoclonal antibodies
- Investigator judgment deeming unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants receive either everolimus combined with investigator's choice of chemotherapy or investigator's choice of chemotherapy alone as first-line treatment for advanced triple-negative breast cancer with LAR subtype.
Regular visits during treatment as per study schedule
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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