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Trial record 6 of 6 for:    Endotag

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03002103
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
SynCore Biotechnology Co., Ltd.

Brief 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.

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


Condition or disease Intervention/treatment Phase
Triple-Negative Breast Cancer Drug: EndoTAG-1 Drug: Paclitaxel Drug: Gemcitabine Hydrochloride Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 23, 2016
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: ET+P+G Drug: EndoTAG-1
Drug: Paclitaxel
Drug: Gemcitabine Hydrochloride
Active Comparator: Control Drug: Paclitaxel
Drug: Gemcitabine Hydrochloride



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]
    from randomization to death from any cause

  2. Clinical benefit rate [ Time Frame: up to 24 months ]
  3. Best overall tumor response rate [ Time Frame: up to 24 months ]
    objective response or SD of any duration

  4. Duration of response [ Time Frame: up to 24 months ]
    the time from randomization to disease progression in the subgroup of patients responding to therapy

  5. Quality of life(QLQ-C30,QLQ-BR23) [ Time Frame: up to 24 months ]
    until disease progression

  6. Post-progression PFS [ Time Frame: up to 12 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gender: Female
  2. Age ≥ 18 years or legal age to provide informed consent according to local regulatory requirements.
  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. At least one measurable or non-measurable tumor lesion according to RECIST version 1.1 as assessed by the Investigator (local radiological image assessment).
  8. ECOG performance status 0 or 1.
  9. Negative pregnancy test (females of childbearing potential).
  10. Willingness to perform double-barrier contraception during study and for 6 months post chemotherapy treatment (females of childbearing potential).
  11. Signed informed consent.

Exclusion Criteria:

  1. Prior first-line chemotherapy for locally recurrent and/or metastatic breast cancer, including visceral disease.
  2. 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).
  3. Major surgery < 4 weeks prior to enrollment.
  4. Cancer immunotherapy at any time.
  5. Severe pulmonary obstructive or restrictive disease.
  6. Uncontrolled inflammatory disease (autoimmune or infectious).
  7. Clinically significant cardiac disease (New York Heart Association [NYHA] stadium > 2).
  8. 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)
  9. Pregnancy or nursing status.
  10. Known positive human immunodeficiency virus (HIV) infection in medical history.
  11. Peripheral neuropathy associated to prior taxane therapy not recovered to grade 0 or 1.
  12. Known hypersensitivity to any component of the EndoTAG®-1, standard paclitaxel and/or gemcitabine formulations.
  13. History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e., basal or squamous cell carcinoma) treated locally.
  14. 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.
  15. Concurrent treatment with other experimental products. Participation in another clinical trial with any investigational product within 30 days prior to study entry.
  16. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002103


Contacts
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Contact: Fern Lim +886227603688 ext 2165 fernlim@syncorebio.com

Locations
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Taiwan
Kaohsiung Veterans General Hospital Terminated
Kaohsiung, Taiwan
Taipei Medical University Shuang Ho Hospital Recruiting
New Taipei City, Taiwan
Principal Investigator: Tsu-Yi Chao, M.D., Ph.D.         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
Principal Investigator: Chih-Chiang Hung, M.D.         
Koo Foundation Sun Yat-Sen Cancer Center Recruiting
Taipei, Taiwan
Principal Investigator: Mei-Ching Liu, MD         
Mackay Memorial Hospital Terminated
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou Terminated
Taoyuan, Taiwan
Sponsors and Collaborators
SynCore Biotechnology Co., Ltd.
Investigators
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Principal Investigator: Tsu-Yi Chao, M.D., Ph.D. Taipei Medical University Shuang Ho Hospital, New Taipei City, Taiwan
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Responsible Party: SynCore Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03002103    
Other Study ID Numbers: CT4005
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs