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

Metastatic Triple-Negative Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04664829
• Other study ID #: BEXMET
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: October 2023
• Source: National Cancer Centre, Singapore
• Contact: Elaine Lim, MD
• Phone: 6436 8000
• Email: elaine.lim.hsuen[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Triple-Negative Breast Carcinoma

Intervention

Drug:
• Bexarotene
Administered orally once a day. Starting dosage: 200mg/m^2
• Capecitabine
Administered orally twice a day. Dosage: 1000mg/m^2

Locations

Country	Name	City	State
Singapore	National Cancer Center Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour transcriptome by RNA sequencing	To characterize the changes in tumour transcriptome upon treatment	From time of first biopsy before the start of treatment, to disease progression, up to 2 years
Primary	Tumour protein profile by multiplex immunohistochemistry	To characterize the changes in tumour protein profile upon treatment	From time of first biopsy before the start of study treatment, to disease progression, up to 2 years
Secondary	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