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

National Cancer Centre, Singapore

Status and phase: Completed; Phase 1

Conditions: Metastatic Triple-Negative Breast Carcinoma

Treatments: Drug: Bexarotene; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT04664829

BEXMET

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Bexarotene and Capecitabine

Experimental group

Treatment:

Drug: Capecitabine

Drug: Bexarotene