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

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ClinicalTrials.gov Identifier: NCT04664829
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : June 13, 2022
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
National Cancer Centre, Singapore

Study Description
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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.


Condition or disease Intervention/treatment Phase
Metastatic Triple-Negative Breast Carcinoma Drug: Bexarotene Drug: Capecitabine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bexarotene and Capecitabine Drug: Bexarotene
Administered orally once a day. Starting dosage: 200mg/m^2
Other Name: Targretin

Drug: Capecitabine
Administered orally twice a day. Dosage: 1000mg/m^2
Other Name: Xeloda


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664829


Contacts
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Contact: Elaine Lim, MD 6436 8000 elaine.lim.hsuen@singhealth.com.sg

Locations
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Singapore
National Cancer Center Singapore Recruiting
Singapore, Singapore, 169690
Sponsors and Collaborators
National Cancer Centre, Singapore
National Medical Research Council (NMRC), Singapore
Investigators
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Principal Investigator: Elaine Lim, MD National Cancer Centre, Singapore
More Information
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Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT04664829    
Other Study ID Numbers: BEXMET
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Centre, Singapore:
Bexarotene
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
 Bexarotene
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents