Clinical trial NCT03358004 (phase 2, status: terminated)
Conditions: triple negative breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: vinorelbine tartrate, capecitabine 500 mg
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, CCCCCOC(=O)NC1=NC(=O)N(C=C1F)[C@@H]1O[C@H](C)[C@@H](O)[C@H]1O
Reason stopped: 
    low accrual rate
  
Eligibility criteria:

        Inclusion Criteria:

          -  Female, aged ≥ 18 years old;

          -  Eastern Cooperative Oncology Group performance status (ECOG -PS) ≤ 1;

          -  Locally advanced or metastatic triple-negative breast cancer, i.e. HER2-negative
             status and ER and PgR negative status (as per local assessment);

          -  Treatment with 1st line chemotherapy (with any drug excepted Bevacizumab-based
             regimens) as per clinical practice, and non-progressive when the treatment was
             terminated;

          -  No more than 6 cycles of the previous chemotherapy;

          -  At least one measurable lesion according to Response Evaluation Criteria in Solid
             Tumors (RECIST, version 1.1);

          -  Willingness and ability to comply with the study protocol as judged by the
             Investigator;

          -  For women who are not postmenopausal (i.e., < 2 years after last menstruation) and who
             are sexually active: agreement to use an adequate method of contraception (oral
             contraceptives, intrauterine contraceptive device, barrier method of contraception in
             conjunction with spermicidal jelly) during the treatment period and for at least 6
             months after the last dose of study drug;

          -  Provision of a written informed consent signed prior to enrolment according to
             ICH/GCP.

        Exclusion Criteria:

          -  Previous treatment with vinorelbine or capecitabine;

          -  1st line therapy with a bevacizumab-based regimen;

          -  Presence of brain metastases;

          -  Any other investigational drug or any anti-cancer treatment (except for radiotherapy,
             if the treatment field does not include the liver);

          -  Inadequate bone marrow, hepatic or renal function including the following:

               1. absolute neutrophils count of < 1.5 cells x 109/L, platelet count < 100 cells x
                  109/L, or hemoglobin < 8 g/L;

               2. serum total bilirubin >1.5 × institution upper limit of normal [ULN], aspartate
                  aminotransferase and alanine aminotransferase >2.5 × ULN, or >5 × ULN for
                  patients with liver metastases, alkaline phosphatase >2.5 × ULN, or >5 × ULN for
                  patients with liver metastases, or >10 × ULN for patients with bone metastases;

               3. serum creatinine concentration >1.5 × ULN, creatinine clearance <50 mL/min
                  calculated according to Cockcroft-Gault equation, and coagulation parameters
                  international normalized ratio >1.5;

          -  With the exception of basal cell carcinoma or cervical cancer in situ, history of
             another malignancy, unless in remission for 5 years or more and judged of negligible
             potential of relapse;

          -  Known dihydropyrimidine dehydrogenase deficiency;

          -  Treatment with sorivudine or its chemically related analogues, such as brivudine,
             within 4 weeks prior to randomization;

          -  Evidence of any significant clinical disorder or concurrent illness or laboratory
             finding that, at the judgment of the Investigator, contra-indicate the inclusion of
             the patient in the study;

          -  Psychiatric disorders or altered mental status precluding understanding of the
             informed consent process and/or completion of the necessary study assessment and
             procedures;

          -  Unable to swallow tablets;

          -  Previous significant surgical resection of stomach or small bowel

          -  Patients requiring long-term oxygen therapy

          -  Known hypersensitivity to any excipients of oral vinorelbine, oral capecitabine and to
             fluoropyrimidine.