Status:
NOT_YET_RECRUITING
Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway
Lead Sponsor:
Peking Union Medical College
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-85 years
Phase:
PHASE3
Brief Summary
This is a multi-center,randomized,phase 3 clinical trial. In the study, HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway after progression on trastuzum...
Detailed Description
This is a multi-center,randomized,phase 3 clinical trial. In the study, HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway after progression on trastuzum...
Eligibility Criteria
Inclusion
- Female, Aged \> 18;
- HER2-positive breast cancer are defined as immunohistochemical (IHC) testing as +++, or IHC++ with FISH testing of positive;
- Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease.
- Patients with HER2-positive metastatic breast cancer who have progressed disease after trastuzumab treatment include the following four types of patients (Note: The following patients are in a parallel relationship):
- Patients with HER2-positive breast cancer who have progressed during adjuvant trastuzumab treatment after surgery; or
- Patients with HER2-positive breast cancer who have relapsed or metastasized after receiving adjuvant trastuzumab therapy; or
- HER2-positive recurrent or metastatic BC patients who have progressed after receiving at least 4 weeks of trastuzumab as first-line treatment ; or
- HER2-positive metastatic BC patients who have never been treated have progressed after receiving at least 4 weeks of trastuzumab as first-line treatment.
- Genetic testing shows that the PI3K/Akt/mTOR pathway related genes are mutated;
- ECOG PS score ≤2, estimated survival time ≥6 months, and can be followed-up;
- Patients with measurable disease as per RECIST 1.1 criteria;
- Cardiopulmonary function is basically normal, LVEF≥50% within 4 weeks before starting treatment;
- An adequate liver function with the following definition:
- Total bilirubin ≤ 1.5 times the upper limit of normal value. Patients with known Gibert's disease can be included in the group if combined bilirubin ≤ 1.5 times the upper limit of normal value;
- AST and ALT ≤2.5 times the upper limit of the normal value; if there is liver metastasis, ≤5 times the upper limit of the normal value (the normal value is the normal value specified by this clinical trial center);
- Have sufficient baseline hematology parameters, defined as follows:
- ANC≥1.5 x 10\^3 /μL;
- Platelet count ≥100 x 10\^3/μL, if it is 75-100 x 10\^3/μL, it may be included in the group, as long as the doctors believe it can be included;
- Hemoglobin ≥9 g/dL.
- Coagulation Indicators: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal, unless drugs known to change INR and aPTT are used;
- No history of serious heart, kidney and other important organs and endocrine disease;
- Female patients of childbearing age have a negative pregnancy test and voluntarily take effective and reliable contraceptive measures;
- The patients voluntarily signed an informed consent form.
Exclusion
- Anyone who has one of the following conditions cannot be selected for this trial:
- Participated in other clinical trials within 4 weeks;
- Have used mTOR inhibitors in the past;
- Previous use of Pyrotinib in first-line treatment stage; previous use of lapatinib is allowed;
- Accompanied by immunosuppressant or chronic corticosteroid medication, or more than 25% bone marrow radiotherapy within 4 weeks;
- Symptomatic CNS metastases or evidence of leptomeningeal disease;
- Gastrointestinal dysfunction or gastrointestinal diseases (including active ulcers);
- Hepatitis B or hepatitis C carriers, or other known chronic liver diseases; HIV positive;
- Known hypersensitivity to any study medication
- Women during pregnancy or lactation;
- Left ventricular ejection fraction \<50%; clinical manifestations of patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular disease;
- Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma;
- The researchers decide that any other medical, social or psychological conditions which are inappropriate to participate in this trial.
Key Trial Info
Start Date :
February 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2027
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04736589
Start Date
February 2 2021
End Date
February 2 2027
Last Update
February 3 2021
Active Locations (1)
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1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China