the Role of Two Different Metronomic Chemotherapy Regimens in Locally Advanced or Metastatic Triple Negative Breast Cancer Patients (TNBC) as Maintenance Therapy After First Line Treatment
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Keep this study
Lead
Mario Negri Institute for Pharmacological Research
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | the Role of Two Different Metronomic Chemotherapy Regimens in Locally Advanced or Metastatic Triple Negative Breast Cancer Patients (TNBC) as Maintenance Therapy After First Line Treatment
