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

NCT ID: NCT04664829

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2025-08-04

Brief Summary

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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

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Conditions

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Metastatic Triple-Negative Breast Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bexarotene and Capecitabine

Group Type EXPERIMENTAL

Bexarotene

Intervention Type DRUG

Administered orally once a day. Starting dosage: 200mg/m\^2

Capecitabine

Intervention Type DRUG

Administered orally twice a day. Dosage: 1000mg/m\^2

Interventions

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Bexarotene

Administered orally once a day. Starting dosage: 200mg/m\^2

Intervention Type DRUG

Capecitabine

Administered orally twice a day. Dosage: 1000mg/m\^2

Intervention Type DRUG

Other Intervention Names

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Targretin Xeloda

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role collaborator

National Cancer Centre, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elaine Lim, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

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National Cancer Center Singapore

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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BEXMET

Identifier Type: -

Identifier Source: org_study_id

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