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

Sponsor
Fudan University
Study ID
NCT04745975
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 1, 2021
Status verified
Apr 2022
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Personalized treatment guided by Mini-PDX
    The tumor tissue is used for drug sensitivity test by Mini-PDX, and acquiring the genetic information by RNA-sequence. Patients with mTNBC will receive personalized treatment guided by the experimental results of mini-PDX and RNA sequencing.
  • Active Comparator: Treatment of Physician's Choice (TPC)
    TPC will be administered per standard of care. Patients randomized to TPC will receive chemotherapy, including but not limited to the following agents: nab-paclitaxel, eribulin, vinorelbine, gemcitabine, capecitabine.

Primary Outcome Measure

Objective response rate [ Time Frame: Through study completion, an expected average of 1 year ]

Central Contacts

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