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

NCT03002103 | Suspended Phase 3

• 1 other identifier: CT4005
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 6

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

Conditions

Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  up to 12 months

Secondary Outcomes (6)

• Overall survival

  24 months

• Clinical benefit rate

  up to 24 months

• Best overall tumor response rate

  up to 24 months

• Duration of response

  up to 24 months

• Quality of life(QLQ-C30,QLQ-BR23)

  up to 24 months

Study Arms (2)

ET+P+G

EXPERIMENTAL

Drug: EndoTAG-1; Drug: Paclitaxel; Drug: Gemcitabine Hydrochloride

Control

ACTIVE COMPARATOR

Drug: Paclitaxel; Drug: Gemcitabine Hydrochloride

Interventions

EndoTAG-1 DRUG

ET+P+G

Paclitaxel DRUG

Control; ET+P+G

Gemcitabine Hydrochloride DRUG

Control; ET+P+G

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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)

Sponsors & Collaborators

• SynCore Biotechnology Co., Ltd.: lead

Study Sites (6)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

MBT-0206; Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Tsu-Yi Chao, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 23, 2016
• Study Start: November 23, 2016
• Primary Completion: March 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

TW (6)