Metastatic Triple-Negative Breast CarcinomaPhase 1NCT04664829
The Role of Bexarotene in Inducing Susceptibility to Chemotherapy in Metastatic TNBC
A Phase 1 study testing Bexarotene and Capecitabine in people with Metastatic Triple-Negative Breast Carcinoma, run by National Cancer Centre, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Metastatic Triple-Negative Breast Carcinoma
- What is being tested?
- Bexarotene and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Oct 2020to 4 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Bexarotene, Capecitabine
- Keywords
- Bexarotene
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BexaroteneDrug
Also called Targretin
Administered orally once a day. Starting dosage: 200mg/m^2
CapecitabineDrug
Also called Xeloda
Administered orally twice a day. Dosage: 1000mg/m^2
| Study group | Role | What they receive |
|---|---|---|
| Bexarotene and Capecitabine | Experimental | Not described Receives: Drug: Bexarotene; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour transcriptome by RNA sequencing
To characterize the changes in tumour transcriptome upon treatment
Measured: From time of first biopsy before the start of treatment, to disease progression, up to 2 years
Tumour protein profile by multiplex immunohistochemistry
To characterize the changes in tumour protein profile upon treatment
Measured: From time of first biopsy before the start of study treatment, to disease progression, up to 2 years
Secondary outcomes (1)
Incidences of treatment related adverse events
Measured: From time of start of study treatment, to 28 days after last dose of study treatment, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Oct 2020
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Triple-Negative Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Elaine Lim, MD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664829
- Sponsor's protocol ID
- BEXMET
- Status last verified
- Sep 2025
- First submitted
- 9 Nov 2020
- Last updated
- 23 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04664829
- Acronym / sponsor ID
- BEXMET
- Keywords
- Bexarotene
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bexarotene and Capecitabine | Experimental | Drug: Bexarotene, Drug: Capecitabine |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BexaroteneAlso: TargretinAdministered orally once a day. Starting dosage: 200mg/m^2 | Drug | Bexarotene and Capecitabine |
| CapecitabineAlso: XelodaAdministered orally twice a day. Dosage: 1000mg/m^2 | Drug | Bexarotene and Capecitabine |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Lim, MD principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bexarotene and Capecitabine in people with Metastatic Triple-Negative Breast Carcinoma, run by National Cancer Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour transcriptome by RNA sequencing (time frame: From time of first biopsy before the start of treatment, to disease progression, up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.