visceral metastatic triple-negative breast cancer

Compare efficacy of weekly infusions of EndoTAG® -1 in combination with paclitaxel and gemcitabine versus paclitaxel in combination with gemcitabine in patients with metastatic TNBC.

EndoTAG-1

Liposomal Paclitaxel

injective

2.63

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

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.

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.