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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT03002103
• Date of registration: 19/12/2016
• Prospective Registration: No
• Primary sponsor: SynCore Biotechnology Co., Ltd.
• Public title: 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
• Scientific 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
• Date of first enrolment: November 23, 2016
• Target sample size: 420
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/show/NCT03002103
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Taiwan

Contacts

• Name: Tsu-Yi Chao, M.D., Ph.D.
• Affiliation: Taipei Medical University Shuang Ho Hospital, New Taipei City, Taiwan

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Triple-Negative Breast Cancer

Intervention(s)

Drug: Paclitaxel

Drug: Gemcitabine Hydrochloride

Drug: EndoTAG-1

Primary Outcome(s)

PFS [Time Frame: up to 12 months]

Secondary Outcome(s)

Best overall tumor response rate [Time Frame: up to 24 months]

Duration of response [Time Frame: up to 24 months]

Clinical benefit rate [Time Frame: up to 24 months]

Quality of life(QLQ-C30,QLQ-BR23) [Time Frame: up to 24 months]

Overall survival [Time Frame: 24 months]

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

Secondary ID(s)

CT4005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors