NCT04745975

Guided Treatment Based on Mini-PDX in Metastatic Triple Negative Breast Cancer

GUided Treatment Based on Mini-PDX in metastaTIc refractOry Triple Negative Breast Cancer(GUMPTION)：a Prospective Randomized Controlled Single Center Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Personalized treatment guided by mini-PDX and RNA sequencing	Personalized treatment guided by mini-PDX and RNA sequencing
DRUG	Nab paclitaxel	Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8, 15, q4w
DRUG	Eribulin	Eribulin 1.4 mg/m2, d1,8 q3w
DRUG	Vinorelbine	Vinorelbine 25mg/m2 d1,8, q3w
DRUG	Gemcitabine	Gemcitabine 1000 mg/m2, d1,8, q3w
DRUG	Capecitabine	Capecitabine 1250 mg/m2 bid po

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2021-02-09
• Last updated: 2022-04-20

Locations

1 site across 1 country: China