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

Primary Purpose

Metastatic Triple-Negative Breast Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Bexarotene
Capecitabine
Sponsored by
National Cancer Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Triple-Negative Breast Carcinoma focused on measuring Bexarotene

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center SingaporeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bexarotene and Capecitabine

Arm Description

Outcomes

Primary Outcome Measures

Tumour transcriptome by RNA sequencing
To characterize the changes in tumour transcriptome upon treatment
Tumour protein profile by multiplex immunohistochemistry
To characterize the changes in tumour protein profile upon treatment

Secondary Outcome Measures

Incidences of treatment related adverse events

Full Information

First Posted
November 9, 2020
Last Updated
October 9, 2023
Sponsor
National Cancer Centre, Singapore
Collaborators
National Medical Research Council (NMRC), Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT04664829
Brief Title
The Role of Bexarotene in Inducing Susceptibility to Chemotherapy in Metastatic TNBC
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore
Collaborators
National Medical Research Council (NMRC), Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Triple-Negative Breast Carcinoma
Keywords
Bexarotene

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bexarotene and Capecitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bexarotene
Other Intervention Name(s)
Targretin
Intervention Description
Administered orally once a day. Starting dosage: 200mg/m^2
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Administered orally twice a day. Dosage: 1000mg/m^2
Primary Outcome Measure Information:
Title
Tumour transcriptome by RNA sequencing
Description
To characterize the changes in tumour transcriptome upon treatment
Time Frame
From time of first biopsy before the start of treatment, to disease progression, up to 2 years
Title
Tumour protein profile by multiplex immunohistochemistry
Description
To characterize the changes in tumour protein profile upon treatment
Time Frame
From time of first biopsy before the start of study treatment, to disease progression, up to 2 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Lim, MD
Phone
6436 8000
Email
elaine.lim.hsuen@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Lim, MD
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Singapore
City
Singapore
ZIP/Postal Code
169690
Country
Singapore
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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