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

Sponsor
National Cancer Centre, Singapore (Other)
Overall Status
Recruiting
CT.gov ID
NCT04664829
Collaborator
National Medical Research Council (NMRC), Singapore (Other)
12
Enrollment
1
Location
1
Arm
32.9
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bexarotene and Capecitabine

Drug: Bexarotene
Administered orally once a day. Starting dosage: 200mg/m^2
Other Names:
  • Targretin

    • Drug: Capecitabine
    Administered orally twice a day. Dosage: 1000mg/m^2
    Other Names:
  • Xeloda

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tumour transcriptome by RNA sequencing [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

    2. Tumour protein profile by multiplex immunohistochemistry [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 Outcome Measures

    1. Incidences of treatment related adverse events [From time of start of study treatment, to 28 days after last dose of study treatment, up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center Singapore Singapore Singapore 169690

    Sponsors and Collaborators

    • National Cancer Centre, Singapore
    • National Medical Research Council (NMRC), Singapore

    Investigators

    • Principal Investigator: Elaine Lim, MD, National Cancer Centre, Singapore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Centre, Singapore
    ClinicalTrials.gov Identifier:
    NCT04664829
    Other Study ID Numbers:
    • BEXMET
    First Posted:
    Dec 11, 2020
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Centre, Singapore
    Bexarotene
    Additional relevant MeSH terms:
    Breast Neoplasms
    Capecitabine
    Bexarotene

    Study Results

    No Results Posted as of Jun 13, 2022