Triple-Negative Breast CancerPhase 3NCT03002103

A Trial Evaluating the Efficacy and Safety of EndoTAG®-1 in Combination With Paclitaxel and Gemcitabine Compared With Paclitaxel and Gemcitabine as First-line Therapy in Patients With Visceral Metastatic Triple-negative Breast Cancer

A Phase 3 study testing EndoTAG-1, Paclitaxel and Gemcitabine Hydrochloride in people with Triple-Negative Breast Cancer, run by SynCore Biotechnology Co., Ltd. at 6 sites in Taiwan.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

This is a prospective, multicenter, open-label, randomized, and controlled trial to test the superiority of EndoTAG®-1 in combination with paclitaxel and gemcitabine versus paclitaxel in combination with gemcitabine. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Triple-Negative Breast Cancer
What is being tested?: EndoTAG-1, Paclitaxel and Gemcitabine Hydrochloride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 420 participants
Where: 6 sitesTaiwan
Study dates: 23 Nov 2016to Jun 2027
Phase: Phase 3
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Gender: Female
Age ≥ 18 years or legal age to provide informed consent according to local regulatory requirements.
Metastatic TNBC confirmed histologically by a certified local laboratory (or existing medical record for confirmation is acceptable for patients in the safety run-in stage) using archival paraffinated material from the original surgery specimens or from later materials, if available. Results of the certified local laboratory must be available to allow for randomization.
Tumors should be considered negative for ER and PrR by immunohistochemistry (IHC) (< 1% positive tumor nuclei, as per American Society of Clinical Oncology/College of American Pathologists [ASCO/CAP] guideline recommendations, Hammond et al 2010) and negative for HER2 by IHC or fluorescent or chromogenic in situ hybridization (FISH or CISH). Patients with equivocal HER2 results by IHC should have the negativity status confirmed by FISH.
Patients must have had prior adjuvant treatment with either sequential or concurrent anthracycline- and/or taxane-based chemotherapy. Patients may have received neoadjuvant treatment prior to the adjuvant anthracycline- and/or taxane-based chemotherapy as well.
Note: Neoadjuvant treatment alone is acceptable only for patients in the safety run-in stage.

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Patients with a disease-free interval (DFI) on anthracycline- and/or taxane-based adjuvant therapy of ≥ 12 months.
Note: This criteria is for main study only.
Patients must be indicated for treatment with polychemotherapy for visceral metastatic disease as judged by the Investigator.
Note: Lymph node metastasis alone is acceptable only for patients in the safety run-in stage.
At least one measurable or non-measurable tumor lesion according to RECIST version 1.1 as assessed by the Investigator (local radiological image assessment).
ECOG performance status 0 or 1.
Negative pregnancy test (females of childbearing potential).
Willingness to perform double-barrier contraception during study and for 6 months post chemotherapy treatment (females of childbearing potential).
Signed informed consent.

Who cannot join

Prior first-line chemotherapy for locally recurrent and/or metastatic breast cancer, including visceral disease.
Brain metastasis/known progressive cerebral metastasis (patients with cerebral metastases in a stable state or after successful surgical or radiological treatment are allowed to participate in the study).
Major surgery < 4 weeks prior to enrollment.
Cancer immunotherapy at any time.
Severe pulmonary obstructive or restrictive disease.
Uncontrolled inflammatory disease (autoimmune or infectious).

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Clinically significant cardiac disease (New York Heart Association [NYHA] stadium > 2).
Results of laboratory tests (hematology, coagulation, clinical chemistry) outside specified limits:
White blood cell (WBC) count ≤ 3 × 109/L
Absolute neutrophil count (ANC) ≤ 1.5 × 109/L
Platelets ≤ 100 × 109/L
Hemoglobin (Hb) ≤ 9.0 g/dL (≤ 5.6 mmol/L)
Activated partial thromboplastin time/international normalized ratio (aPTT/INR) > 1.5 × upper limit of normal (ULN)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 2.5 × ULN (> 5 × ULN if presence of liver metastasis)
Alkaline phosphatase (AP) > 2 × ULN (> 5 × ULN if presence of liver metastasis)
Total bilirubin > 1.5 × ULN (> 2.5 × ULN if presence of liver metastasis)
Pregnancy or nursing status.
Known positive human immunodeficiency virus (HIV) infection in medical history.
Peripheral neuropathy associated to prior taxane therapy not recovered to grade 0 or 1.
Known hypersensitivity to any component of the EndoTAG®-1, standard paclitaxel and/or gemcitabine formulations.
History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e., basal or squamous cell carcinoma) treated locally.
History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial.
Concurrent treatment with other experimental products. Participation in another clinical trial with any investigational product within 30 days prior to study entry.
Positive test for hepatitis B (hepatitis B virus surface antigen [HBsAg] positive; or HBsAg negative but anti-hepatitis B virus core [HBc] antibody positive and HBV DNA positive) or hepatitis C (anti hepatitis C virus [HCV] antibody positive). Patients that are anti-HCV antibody positive can also be judged eligible if further HCV RNA detection shows negative results.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Taiwan6 sites

Kaohsiung Veterans General Hospital
Kaohsiung City
Taipei Medical University Shuang Ho Hospital
New Taipei City
Taichung Veterans General Hospital
Taichung
Koo Foundation Sun Yat-Sen Cancer Center
Taipei
Mackay Memorial Hospital
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan

Other trials in Taiwan

About this study

Official title: An Open-label, Randomized, Controlled Phase III Trial Evaluating the Efficacy and Safety of EndoTAG®-1 in Combination With Paclitaxel and Gemcitabine Compared With Paclitaxel and Gemcitabine as First-line Therapy in Patients With Visceral Metastatic Triple-negative Breast Cancer

An independent data safety monitoring board (DSMB) will be established to decide on the recommended dose (RD) of EndoTAG®-1, paclitaxel and gemcitabine to be used throughout the trial and to monitor the patients' safety and treatment efficacy data

Conditions: Triple-Negative Breast Cancer
Being tested: EndoTAG-1, Paclitaxel, Gemcitabine Hydrochloride
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.

Study groups in NCT03002103
Study group	Role	What they receive
ET+P+G	Experimental	Not described Receives: Drug: EndoTAG-1; Drug: Paclitaxel; Drug: Gemcitabine Hydrochloride
Control	Active comparator	Not described Receives: Drug: Paclitaxel; Drug: Gemcitabine Hydrochloride

What is being measured

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

PFS
Progression free survival defined as the time from randomization to disease progression based on blinded central radiological image evaluation according to response evaluation criteria in solid tumors (RECIST, version 1.1) or death from any cause, whichever occurs first
Measured: up to 12 months

Secondary outcomes (6)

Overall survival
from randomization to death from any cause
Measured: 24 months
Clinical benefit rate
Measured: up to 24 months
Best overall tumor response rate
objective response or SD of any duration
Measured: up to 24 months
Duration of response
the time from randomization to disease progression in the subgroup of patients responding to therapy
Measured: up to 24 months
Quality of life(QLQ-C30,QLQ-BR23)
until disease progression
Measured: up to 24 months
Post-progression PFS
as the time from start of second and subsequent lines of therapy administered after trial participation to disease progression (based on local radiological image evaluation or clinical assessment) or death from any cause, whichever occurs first
Measured: up to 12 months

Timeline

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

23 Nov 2016Jun 2027

First posted23 Dec 2016 (estimated)
Study start23 Nov 2016
Primary completionMar 2025 (estimated)
Study completionJun 2027 (estimated)

Why it stopped: study design reconsideration

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.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 420 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03002103
Sponsor's protocol ID: CT4005
Status last verified: Apr 2023
First submitted: 19 Dec 2016
Last updated: 26 Apr 2023
Results posted: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Controlled Phase III Trial Evaluating the Efficacy and Safety of EndoTAG®-1 in Combination With Paclitaxel and Gemcitabine Compared With Paclitaxel and Gemcitabine as First-line Therapy in Patients With Visceral Metastatic Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT03002103
Acronym / sponsor ID: CT4005
Conditions: Triple-Negative Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: SuspendedReason stopped: study design reconsideration
Enrolment: 420 participants (estimated)
Lead sponsor: SynCore Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 23 Nov 2016 (actual)
Primary completion: Mar 2025 (estimated)
Study completion: Jun 2027 (estimated)
First posted: 23 Dec 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ET+P+G	Experimental	Drug: EndoTAG-1, Drug: Paclitaxel, Drug: Gemcitabine Hydrochloride
Control	Active comparator	Drug: Paclitaxel, Drug: Gemcitabine Hydrochloride

Who may qualify

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

Key inclusion criteria (15 listed)

Gender: Female
Age ≥ 18 years or legal age to provide informed consent according to local regulatory requirements.
Metastatic TNBC confirmed histologically by a certified local laboratory (or existing medical record for confirmation is acceptable for patients in the safety run-in stage) using archival paraffinated material from the original surgery specimens or from later materials, if available. Results of the certified local laboratory must be available to allow for randomization.
Tumors should be considered negative for ER and PrR by immunohistochemistry (IHC) (< 1% positive tumor nuclei, as per American Society of Clinical Oncology/College of American Pathologists [ASCO/CAP] guideline recommendations, Hammond et al 2010) and negative for HER2 by IHC or fluorescent or chromogenic in situ hybridization (FISH or CISH). Patients with equivocal HER2 results by IHC should have the negativity status confirmed by FISH.
Patients must have had prior adjuvant treatment with either sequential or concurrent anthracycline- and/or taxane-based chemotherapy. Patients may have received neoadjuvant treatment prior to the adjuvant anthracycline- and/or taxane-based chemotherapy as well.

Key exclusion criteria (24 listed)

Prior first-line chemotherapy for locally recurrent and/or metastatic breast cancer, including visceral disease.
Brain metastasis/known progressive cerebral metastasis (patients with cerebral metastases in a stable state or after successful surgical or radiological treatment are allowed to participate in the study).
Major surgery < 4 weeks prior to enrollment.
Cancer immunotherapy at any time.
Severe pulmonary obstructive or restrictive disease.

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
EndoTAG-1	Drug	ET+P+G
Paclitaxel	Drug	Control, ET+P+G
Gemcitabine Hydrochloride	Drug	Control, ET+P+G

Primary outcome

PFS
Time frame: up to 12 months
Progression free survival defined as the time from randomization to disease progression based on blinded central radiological image evaluation according to response evaluation criteria in solid tumors (RECIST, version 1.1) or death from any cause, whichever occurs first

6 secondary outcomes

Overall survival
Time frame: 24 months
Clinical benefit rate
Time frame: up to 24 months
Best overall tumor response rate
Time frame: up to 24 months
Duration of response
Time frame: up to 24 months
Quality of life(QLQ-C30,QLQ-BR23)
Time frame: up to 24 months
Post-progression PFS
Time frame: up to 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.

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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.

Tsu-Yi Chao, M.D., Ph.D. principal investigator

Taipei Medical University Shuang Ho Hospital, New Taipei City, Taiwan

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EndoTAG-1, Paclitaxel and Gemcitabine Hydrochloride in people with Triple-Negative Breast Cancer, run by SynCore Biotechnology Co., Ltd. at 6 sites in Taiwan.

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 15 inclusion and 24 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: paused, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

PFS (time frame: up to 12 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 NCT03002103.

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 26 Apr 2023.