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OpenTrials
Completed

NCT Number: NCT04664829

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

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.

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Key information

Conditions

Metastatic Triple-Negative Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Singapore

Singapore, 168583

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bexarotene

Drug

Administered orally once a day. Starting dosage: 200mg/m^2

Other names: Targretin

Capecitabine

Drug

Administered orally twice a day. Dosage: 1000mg/m^2

Other names: Xeloda

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2020
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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