The Role of Bexarotene in Inducing Susceptibility to Chemotherapy in Metastatic TNBC
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 30, 2024
Interventions
- Drug: Bexarotene
- Administered orally once a day. Starting dosage: 200mg/m^2
- Drug: Capecitabine
- Administered orally twice a day. Dosage: 1000mg/m^2
Arms, Groups and Cohorts
- Experimental: Bexarotene and Capecitabine
Clinical Trial Outcome Measures
Primary Measures
- 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
Secondary Measures
- 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
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: 21 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- National Cancer Centre, Singapore
- Collaborator
- National Medical Research Council (NMRC), Singapore
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Elaine Lim, MD, Principal Investigator, National Cancer Centre, Singapore
- Overall Contact(s)
- Elaine Lim, MD, 6436 8000, elaine.lim.hsuen@singhealth.com.sg
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