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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Centre, Singapore
• Collaborator: National Medical Research Council (NMRC), Singapore
• Treatments: Bexarotene; Capecitabine

Criteria

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