Guided Treatment Based on Mini-PDX in Metastatic Triple Negative Breast Cancer
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
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. Although the addition of immune checkpoint inhibitors could improve
the outcome of patients with metastatic triple-negative breast cancer (mTNBC), chemotherapy
has been the standard of care for systemic treatment for patients with mTNBC. Prognoses
remain poor, with reported median overall survival estimates of approximately 18 months or
less with available treatments. A meta-analysis of seven clinical trials showed that the
median objective response rate (ORR) of second or later line of chemotherapy in mTNBC was
only 11%.
Patient-derived xenograft (PDX) tumor model, which preserves the histologic and genetic
characteristics of patients' tumors, has shown its predictive value of clinical outcomes and
are used for preclinical drug evaluation, biomarker identification, biological studies, and
personalized medicine strategies. However, long time period and low success rate has limited
its application in clinical practice.
Mini patient derived xenograft (miniPDX) offers an effective alternative as it only takes
about 7 days for drug sensitivity test and could thus provide guidance for prompt
personalized treatment for each patient.
Thus, the investigators conduct this single-center, prospective, randomized controlled
clinical study to investigate the efficacy of guided treatment based on Mini-PDX in patients
with metastatic refractory triple negative breast cancer.