Actively Recruiting
Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype
Led by Fudan University · Updated on 2024-01-16
203
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy of investigator's choice of chemotherapy, either alone or in combination with everolimus, in treating patients with locally recurrent inoperable or metastatic triple-negative breast cancer, luminal androgen receptor (LAR) subtype with PI3K/AKT/mTOR (PAM) pathway mutation, as the first-line treatment.
CONDITIONS
Official 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival longer than 3 months
- Pathologically confirmed triple-negative breast cancer (ER <1%, PR <1%, HER2 0 or +, or HER2++ with negative FISH) of luminal androgen receptor subtype with PAM pathway mutation
- Locally recurrent inoperable or metastatic breast cancer; local recurrence must be confirmed as not surgically removable
- No prior chemotherapy, targeted therapy, or other treatments for advanced/metastatic breast cancer
- At least one measurable or unmeasurable lesion not previously irradiated, evaluable by CT or MRI per RECIST 1.1
- Normal main organ function meeting specified blood count and biochemical standards
- No radiotherapy, endocrine, molecular targeted therapy, or surgery within 3 weeks before study start, fully recovered from prior treatment toxicities
- No peripheral neuropathy or only grade I peripheral neurotoxicity
- Fertile women must use medically approved contraception during and for 3 months after treatment
- Willingness to voluntarily join the study, sign informed consent, and comply with follow-up
You will not qualify if you...
- Known or suspected central nervous system metastases confirmed by enhanced CT or MRI within 28 days before treatment
- History of serious or uncontrolled heart disease including recent heart failure, angina, myocardial infarction, or ventricular arrhythmia
- Persistent grade 1 or higher adverse events from previous treatments, except hair loss or other documented exceptions
- Major surgery within 3 weeks prior to treatment, except minor outpatient procedures
- Pregnant or breastfeeding women
- Other malignancies within 5 years except cured cervical carcinoma in situ or certain skin cancers
- Inability to swallow, chronic diarrhea, intestinal obstruction affecting drug absorption
- Uncontrolled third space effusions like pleural fluid or ascites
- Participation in other anti-tumor drug trials within 4 weeks before starting study drug
- Long-term unhealed wounds or incomplete fractures
- Active Hepatitis B or C infection or abnormal liver function due to these infections
- Known allergies to study drugs or related monoclonal antibodies
- Investigator judgment deeming the patient unsuitable for study participation
AI-Screening
AI-Powered Screening
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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
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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