The Role of Bexarotene in Inducing Susceptibility to Chemotherapy in Metastatic TNBC

Overview

Triple-negative breast cancer (TNBC) is biologically aggressive and has limited systemic treatment options, often compounded by treatment resistance. Cell state transitions, e.g. epithelial-to-mesenchymal transition (EMT) govern cancer cell behaviour. The investigators hypothesize that by inducing change in cell state change, TNBC cells that have manifested taxane-resistance will be more sensitized to subsequent chemotherapy.

Full Title of Study: “Metastatic Triple-Negative Taxane-Resistant Breast Cancer: Investigating the Role of Bexarotene in Inducing Susceptibility to Chemotherapy by Differentiating Cancer Cells From a Mesenchymal-Like to an Epithelial-Like Phenotype”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2024

Interventions

  • Drug: Bexarotene
    • Administered orally once a day. Starting dosage: 200mg/m^2
  • Drug: Capecitabine
    • Administered orally twice a day. Dosage: 1000mg/m^2

Arms, Groups and Cohorts

  • Experimental: Bexarotene and Capecitabine

Clinical Trial Outcome Measures

Primary Measures

  • Tumour transcriptome by RNA sequencing
    • Time Frame: From time of first biopsy before the start of treatment, to disease progression, up to 2 years
    • To characterize the changes in tumour transcriptome upon treatment
  • Tumour protein profile by multiplex immunohistochemistry
    • Time Frame: From time of first biopsy before the start of study treatment, to disease progression, up to 2 years
    • To characterize the changes in tumour protein profile upon treatment

Secondary Measures

  • Incidences of treatment related adverse events
    • Time Frame: From time of start of study treatment, to 28 days after last dose of study treatment, up to 2 years

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with histologically or cytologically proven metastatic TNBC – Patients whose TNBC has progressed after prior taxane therapy in the (neo)adjuvant or metastatic setting, and have not received Capecitabine or 5-fluorouracil – Females aged 21 years and older – ECOG performance status 0 or 1 – Life expectancy greater than three months – Patients have normal organ and marrow function – Site(s) of disease amenable to serial bedside biopsies before, during and after study treatment Exclusion Criteria:

  • Previous palliative radiotherapy to potentially biopsy-able lesion – Active symptomatic central nervous system (CNS) metastases – Spinal cord compression not definitively treated with surgery and/or radiation – Uncontrolled pleural effusion, pericardial effusion, ascites requiring recurrent drainage procedures

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Cancer Centre, Singapore
  • Collaborator
    • National Medical Research Council (NMRC), Singapore
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elaine Lim, MD, Principal Investigator, National Cancer Centre, Singapore
  • Overall Contact(s)
    • Elaine Lim, MD, 6436 8000, elaine.lim.hsuen@singhealth.com.sg

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