Status:
UNKNOWN
Guided Treatment Based on Mini-PDX in Metastatic Triple Negative Breast Cancer
Lead Sponsor:
Fudan University
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Triple-negative breast cancer constitutes 15-20% of cases of breast cancer and is defined by the absence of estrogen receptors, progesterone receptors, and overexpression or gene amplification of HER2...
Eligibility Criteria
Inclusion
- 1\) Women aged 18-70 years;
- 2\) an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- 3\) Estimated lifetime is ≥ 3 months;
- 4\) Histopathologically confirmed recurrent (unresectable) or metastatic triple-negative breast cancer; ER and PR negative is defined as ER \<1% positive, PR \<1% positive. HER-2 negative is defined as HER-2 (-) or (1+) by immunohistochemistry, HER-2 (2+) must be tested by FISH with negative result, HER-2 (1+) (1+), FISH is optional and negative;
- 5\) Have at least one measurable target lesion according to RECIST 1.1 criteria;
- 6\) Biopsy of the tumor lesion and the specimen passes laboratory quality control;
- 7\) A minimum of 2 prior cytotoxic chemotherapy regimens (including at least one line of platinum-containing regimen) in metastatic settings are required prior to enrollment in this trial;
- 8\) Adequate organ function, i.e. meeting the following criteria.
- Hb ≥ 90 g/L (no transfusion within 14 days); ANC ≥ 1.5 × 109 /L; PLT ≥ 75 × 109 /L.
- Liver function: total bilirubin TBIL ≤ 1.5×ULN (upper limit of normal); ALT and AST ≤ 3×ULN.
- serum Cr ≤ 1.5×ULN.
- 9\) Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.
Exclusion
- 1）Pregnancy or lactation；
- 2）History of autoimmune disease；
- 3）Anticancer- and radiation therapy-related toxicities have not resolved or downgraded to Grade 1 or less;
- 4\) Symptomatic central nervous system (CNS) disease;
- 5\) Previous treatment of Immune checkpoint inhibitors;
- 6\) History of other malignancies within the past five years, with the exception of cured non-malignant melanoma of the skin and carcinoma in situ of the cervix.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04745975
Start Date
February 1 2021
End Date
January 1 2023
Last Update
April 20 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032