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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04664829

Enrollment

Registered

2020-12-11

Start date

2020-10-01

Completion date

2025-08-04

Last updated

2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Triple-Negative Breast Carcinoma

Keywords

Bexarotene

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.

Interventions

DRUGBexarotene

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

DRUGCapecitabine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Measure	Time frame
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026