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CompletedNCT04664829Updated Sep 23, 2025

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

A Phase 1 interventional study of Bexarotene and Capecitabine in Metastatic Triple-Negative Breast Carcinoma, sponsored by National Cancer Centre, Singapore. Completed at 1 site in Singapore. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by National Cancer Centre, Singapore · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
21 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Metastatic Triple-Negative Breast Carcinoma

Keywords

  • Bexarotene
03

In context

Triple Negative Breast Neoplasms

1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.

This study's enrollment of 12 is below the median of 61 across 982 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

National Cancer Centre, Singapore is the lead sponsor of 116 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Bexarotene and Capecitabine

    Drug: Bexarotene · Drug: Capecitabine

Interventions

  • DrugBexarotene

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

    Also known as: Targretin

  • DrugCapecitabine

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

    Also known as: Xeloda

06

What researchers measure

Primary outcomes

  1. Tumour transcriptome by RNA sequencing

    To characterize the changes in tumour transcriptome upon treatment

    Time frame: From time of first biopsy before the start of treatment, to disease progression, up to 2 years

  2. Tumour protein profile by multiplex immunohistochemistry

    To characterize the changes in tumour protein profile upon treatment

    Time frame: From time of first biopsy before the start of study treatment, to disease progression, up to 2 years

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

07

Study locations

1 site
  • National Cancer Center Singapore
    Singapore, 168583, Singapore
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04664829
Lead sponsor
National Cancer Centre, Singapore
Collaborators
National Medical Research Council (NMRC), Singapore
Responsible party
Sponsor
First posted
Dec 11, 2020
Start date
Oct 1, 2020
Primary completion
Aug 4, 2025
Completion
Aug 4, 2025
Last update
Sep 23, 2025

Study contacts

Elaine Lim, MD
principal investigator · National Cancer Centre, Singapore

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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