NCT04664829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2020

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

4.8 years

First QC Date

November 9, 2020

Last Update Submit

September 22, 2025

Conditions

Metastatic Triple-Negative Breast Carcinoma

Keywords

Bexarotene

Outcome Measures

Primary Outcomes (2)

  • Tumour transcriptome by RNA sequencing

    To characterize the changes in tumour transcriptome upon treatment

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

  • Tumour protein profile by multiplex immunohistochemistry

    To characterize the changes in tumour protein profile upon treatment

    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

    From time of start of study treatment, to 28 days after last dose of study treatment, up to 2 years

Study Arms (1)

Bexarotene and Capecitabine

EXPERIMENTAL
Drug: BexaroteneDrug: Capecitabine

Interventions

BexaroteneDRUG

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

Also known as: Targretin
Bexarotene and Capecitabine
CapecitabineDRUG

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

Also known as: Xeloda
Bexarotene and Capecitabine

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center Singapore

Singapore, 168583, Singapore

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

BexaroteneCapecitabine

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Elaine Lim, MD

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

December 11, 2020

Study Start

October 1, 2020

Primary Completion

August 4, 2025

Study Completion

August 4, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations

SG(1)