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

October 9, 2023 updated by: National Cancer Centre, Singapore

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 169690
        • Recruiting
        • National Cancer Center Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From time of first biopsy before the start of treatment, to disease progression, up to 2 years
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
From time of first biopsy before the start of study treatment, to disease progression, up to 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

National Medical Research Council (NMRC), Singapore

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEXMET

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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