The Role of Bexarotene in Inducing Susceptibility to Chem... | NCT04664829

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

NCT04664829

Sponsor

National Cancer Centre, Singapore

Status

Completed

Last Update Posted

Sep 23, 2025Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Metastatic Triple-Negative Breast Carcinoma

Interventions

Bexarotene
Capecitabine

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Aug 4, 2025Actual

Completion Date

Aug 4, 2025Actual

First Submitted Date

Nov 9, 2020

First Submission Date that Met QC Criteria

Dec 7, 2020

First Posted Date

Dec 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2025

Last Update Posted Date

Sep 23, 2025Actual

Name	Class
National Medical Research Council (NMRC), Singapore	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bexarotene and Capecitabine	Experimental		Drug: Bexarotene Drug: Capecitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bexarotene	Drug	Administered orally once a day. Starting dosage: 200mg/m^2	Bexarotene and Capecitabine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elaine Lim, MD	National Cancer Centre, Singapore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center Singapore		Singapore		168583	Singapore

Condition Browse Module

MeSH Terms

ID	Term
D064726	Triple Negative Breast Neoplasms

Ancestor Terms

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077610	Bexarotene
D000069287	Capecitabine

Ancestor Terms

ID	Term
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided