Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT03358004
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03358004
Study Brief:
Protocol Section:
NCT03358004