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

National Cancer Centre, Singapore12 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Triple-Negative Breast Carcinoma

Interventions

BexaroteneDRUG

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

CapecitabineDRUG

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

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Center Singapore

Singapore, Singapore

Outcomes

Primary Outcomes

Tumour transcriptome by RNA sequencing

To characterize the changes in tumour transcriptome upon treatment

Time frame: 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

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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