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

Phase 1

Recruiting

• Conditions: Metastatic Triple-Negative Breast Carcinoma
• Interventions: Drug: Bexarotene; Drug: Capecitabine

• Registration Number: NCT04664829
• Lead Sponsor: National Cancer Centre, Singapore

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 available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bexarotene and Capecitabine	Bexarotene	-
Bexarotene and Capecitabine	Capecitabine	-

Primary Outcome Measures

Name	Time	Method
Tumour protein profile by multiplex immunohistochemistry	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
Tumour transcriptome by RNA sequencing	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

Secondary Outcome Measures

Name	Time	Method
Incidences of treatment related adverse events	From time of start of study treatment, to 28 days after last dose of study treatment, up to 2 years

Trial Locations

Locations (1)

National Cancer Center Singapore; 🇸🇬 Singapore, Singapore