Using Bexarotene to Enhance Chemotherapy Effectiveness in Advanced Triple-Negative Breast Cancer
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
This study is testing if adding Bexarotene to chemotherapy can help people with advanced triple-negative breast cancer respond better to treatment after their cancer has progressed.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | National Cancer Centre, Singapore Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04664829 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Bexarotene to induce changes in the cell state of metastatic triple-negative breast carcinoma (TNBC) cells, potentially making them more susceptible to chemotherapy. The study focuses on patients whose TNBC has progressed after prior taxane therapy and who have not yet received Capecitabine or 5-fluorouracil. By understanding how Bexarotene affects cancer cell behavior, the researchers aim to improve treatment outcomes for patients with this aggressive form of breast cancer. The trial will involve administering Bexarotene alongside Capecitabine to evaluate its effectiveness in overcoming chemotherapy resistance.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 21 and older with metastatic TNBC that has progressed after taxane therapy.
Not a fit: Patients with active symptomatic CNS metastases or those who have received prior palliative radiotherapy to potentially biopsy-able lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment options and outcomes for patients with metastatic TNBC who have limited responses to current therapies.
How similar studies have performed: While the use of Bexarotene in this context is novel, previous studies have explored similar approaches to enhance chemotherapy sensitivity in resistant cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Singapore
- National Cancer Center Singapore — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Elaine Lim, MD — National Cancer Centre, Singapore
- Study coordinator: Elaine Lim, MD
- Email: elaine.lim.hsuen@singhealth.com.sg
- Phone: 6436 8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.