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

NCT04745975 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-04-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xichun Hu, M.D. · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04745975 on ClinicalTrials.gov