Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04745975
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2021-02-04
Brief Title:
Guided Treatment Based on Mini-PDX in Metastatic Triple Negative Breast Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
GUided Treatment Based on Mini-PDX in metastaTIc refractOry Triple Negative Breast CancerGUMPTIONa Prospective Randomized Controlled Single Center Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None