Status:
TERMINATED
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
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
TNBC, defined by the lack of immunohistochemical staining for oestrogen receptors, progesterone receptors, and lack of overexpression or amplification of HER2/neu, has an aggressive biological behavio...
Eligibility Criteria
Inclusion
- 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
- 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:
- absolute neutrophils count of \< 1.5 cells x 109/L, platelet count \< 100 cells x 109/L, or hemoglobin \< 8 g/L;
- 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;
- 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.
Key Trial Info
Start Date :
June 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03358004
Start Date
June 14 2017
End Date
September 13 2018
Last Update
October 5 2018
Active Locations (30)
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1
AOU Ospedali riuniti di Ancona
Torrette, Ancona, Italy, 60126
2
ASST Monza
Monza, MB, Italy, 20052
3
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, Italy, 56126
4
Azienda Ospedaliero Universitaria di Parma
Parma, PR, Italy, 43126