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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 : December 11, 2020
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
National Cancer Centre, Singapore

Tracking Information
First Submitted Date  ICMJE November 9, 2020
First Posted Date  ICMJE December 11, 2020
Last Update Posted Date December 11, 2020
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Bexarotene in Inducing Susceptibility to Chemotherapy in Metastatic TNBC
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Triple-Negative Breast Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Bexarotene and Capecitabine
Interventions:
  • Drug: Bexarotene
  • Drug: Capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histologically or cytologically proven metastatic TNBC
  • Patients whose TNBC has progressed after prior taxane therapy in the 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elaine Lim, MD 6436 8000 elaine.lim.hsuen@singhealth.com.sg
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04664829
Other Study ID Numbers  ICMJE BEXMET
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Centre, Singapore
Study Sponsor  ICMJE National Cancer Centre, Singapore
Collaborators  ICMJE National Medical Research Council (NMRC), Singapore
Investigators  ICMJE
Principal Investigator: Elaine Lim, MD National Cancer Centre, Singapore
PRS Account National Cancer Centre, Singapore
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP