The Role of Bexarotene in Inducing Susceptibility to Chemotherapy in Metastatic TNBC
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|ClinicalTrials.gov Identifier: NCT04664829|
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Triple-Negative Breast Carcinoma||Drug: Bexarotene Drug: Capecitabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
|Experimental: Bexarotene and Capecitabine||
Administered orally once a day. Starting dosage: 200mg/m^2
Other Name: Targretin
Administered orally twice a day. Dosage: 1000mg/m^2
Other Name: Xeloda
- Tumour transcriptome by RNA sequencing [ Time Frame: 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
- Tumour protein profile by multiplex immunohistochemistry [ Time Frame: 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
- Incidences of treatment related adverse events [ Time Frame: From time of start of study treatment, to 28 days after last dose of study treatment, up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664829
|Contact: Elaine Lim, MD||6436 firstname.lastname@example.org|
|National Cancer Center Singapore||Recruiting|
|Singapore, Singapore, 169690|
|Principal Investigator:||Elaine Lim, MD||National Cancer Centre, Singapore|