Triple Negative Breast CancerPhase 2NCT03244358

Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer

A Phase 2 study testing Epalrestat in people with Triple Negative Breast Cancer, run by Sun Yat-sen University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple negative breast Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Triple Negative Breast Cancer
What is being tested?: Epalrestat
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteChina
Study dates: 1 Mar 2017to 1 Dec 2020
Phase: Phase 2
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 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female ≥ 18 years, ≤70 years.
Minimum life expectancy 16 weeks
Histologicalconfirmation of hormone receptor negative and HER2 negative breast cancer(IHC:ER -, PR-) on primary tumour at diagnosis/on biopsy of metastasis
Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection
ECOG 0-2 with no deterioration over previous 2 weeks Measurable disease
Adequate bone marrow and organ function
Availability of archival tumour sample or fresh biopsy Informed consent
Normal organ function

Who cannot join

Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days prior to study treatment
Last dose of palliative radiotherapy <7 days prior to study treatment
Rapidly progressive visceral disease not suitable for further therapy
Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for ≥ 4 weeks study treatment
Major surgery (excluding placement of vascular access) within 4 weeks before study treatment
Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV

Show all 11Show fewer

With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
Elevated ALP in absence of bone metastasis
Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
Participation in another study with investigational product during last 30 days
Inability or unwillingness to comply with study procedures, including inability to take regular oral medication

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study

To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple negative breast

Read the detailed description

This is a phase II,single center,prospective, single arm clinical trials. The objective is to evaluate the efficacy and safetyof Epalrestat in the treatment of metastatic triple negative breast.Primary endpoint is 16-week clinical benefit rate (CBR).

Conditions: Triple Negative Breast Cancer
Being tested: Epalrestat
Keywords: Triple Negative Breast Cancer, Epalrestat
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.

EpalrestatDrug
Also called Tanglin (Yangtze River Pharmaceutical Group), China
Epalrestat 50mg tid added to standard chemotherapy treatment

Study groups in NCT03244358
Study group	Role	What they receive
Epalrestat	Experimental	Epalrestat added to standard treatment Receives: Drug: Epalrestat

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free survival (PFS)
the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
Measured: 30 months

Secondary outcomes (2)

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 30 months
Overall Survival
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20171 Dec 2020

First posted9 Aug 2017
Study start1 Mar 2017
Primary completion1 Dec 2020
Study completion1 Dec 2020

Why it stopped: Difficulty accruing subjects the study accrual was closed

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03244358
Sponsor's protocol ID: SYSUCC-010
Status last verified: Jan 2021
First submitted: 23 Jul 2017
Last updated: 29 Jan 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study
ClinicalTrials.gov ID: NCT03244358
Acronym / sponsor ID: SYSUCC-010
Conditions: Triple Negative Breast Cancer
Keywords: Triple Negative Breast Cancer, Epalrestat
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty accruing subjects the study accrual was closed
Enrolment: 12 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 1 Mar 2017 (actual)
Primary completion: 1 Dec 2020 (actual)
Study completion: 1 Dec 2020 (actual)
First posted: 9 Aug 2017 (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.

To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple negative breast

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Epalrestat	Experimental	Drug: EpalrestatEpalrestat added to standard treatment

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Female ≥ 18 years, ≤70 years.
Minimum life expectancy 16 weeks
Histologicalconfirmation of hormone receptor negative and HER2 negative breast cancer(IHC:ER -, PR-) on primary tumour at diagnosis/on biopsy of metastasis
Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection
ECOG 0-2 with no deterioration over previous 2 weeks Measurable disease

Key exclusion criteria (11 listed)

Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days prior to study treatment
Last dose of palliative radiotherapy <7 days prior to study treatment
Rapidly progressive visceral disease not suitable for further therapy
Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for ≥ 4 weeks study treatment
Major surgery (excluding placement of vascular access) within 4 weeks before study treatment

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
EpalrestatAlso: Tanglin (Yangtze River Pharmaceutical Group), ChinaEpalrestat 50mg tid added to standard chemotherapy treatment	Drug	Epalrestat

Primary outcome

Progression-free survival (PFS)
Time frame: 30 months
the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

2 secondary outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 30 months
Overall Survival
Time frame: 3 years

Results and safety

The study was stopped early (reason given: Difficulty accruing subjects the study accrual was closed). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
Individual participant dataSharing planned: No

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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.

zhongyu yuan, M.D. principal investigator

Sun Yat-sen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epalrestat in people with Triple Negative Breast Cancer, run by Sun Yat-sen University at 1 site in China.

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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 29 Jan 2021. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Difficulty accruing subjects the study accrual was closed). Results are not available in the source record.

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?

Progression-free survival (PFS) (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03244358.

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 29 Jan 2021.