Locally advanced or metastatic triple negative breast cancer (TNBC) MedDRA version: 20.0 Level: PT Classification code 10075566 Term: Triple negative breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classificati
Conditions
Interventions
Trade Name: Navelbine 20 mg capsule
Product Name: Navelbine
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: VINORELBINE TARTRATE
CAS Number: 125317-39-7
Current Sponsor code: NA
Concentration
Sponsors
IRCCS - Istituto di Ricerche Farmacologiche Mario Negri
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female, aged = 18 years old; 2. Eastern Cooperative Oncology Group performance status (ECOG –PS) = 1; 3. Locally advanced or metastatic triple-negative breast cancer, i.e. HER2-negative status and ER and PgR negative status (as per local assessment); 4. Treatment with 1st line chemotherapy (with any drug excepted Bevacizumab-based regimens) as per clinical practice, and non-progressive when the treatment was terminated; 5. No more than 6 cycles of the previous chemotherapy; 6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1); 7. Willingness and ability to comply with the study protocol as judged by the Investigator; 8. For women who are not postmenopausal (i.e., =65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. Previous treatment with vinorelbine or capecitabine; 2. 1st line therapy with a bevacizumab-based regimen; 3. Presence of brain metastases; 4. Any other investigational drug or any anti-cancer treatment (except for radiotherapy, if the treatment field does not include the liver); 5. Inadequate bone marrow, hepatic or renal function including the following: a. absolute neutrophils count of 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; c. serum creatinine concentration >1.5 × ULN, creatinine clearance 1.5; 6. 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; 7. Known dihydropyrimidine dehydrogenase deficiency; 8. Treatment with sorivudine or its chemically related analogues, such as brivudine, within 4 weeks prior to randomization; 9. 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; 10. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study assessment and procedures; 11. Unable to swallow tablets; 12. Previous significant surgical resection of stomach or small bowel 13. Patients requiring long-term oxygen therapy 14. Known hypersensitivity to any excipients of oral vinorelbine, oral capecitabine and to fluoropyrimidine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity of the two study regimens (oral metronomic schedule of VNR and combination of oral metronomic schedule of VNR with fixed doses of CAPE) in terms of proportion of patients alive and without disease progression after 12 weeks of maintenance therapy.;Secondary Objective: To evaluate: - the two treatment regimens in terms of clinical benefit, overall survival (OS) and progression free survival (PFS). - the tolerability and safety profile of each treatment regimen;Primary end point(s): Proportion of patients alive and without progression after 12 weeks of maintenance therapy (PFS12w).;Timepoint(s) of evaluation of this end point: after 12 weeks of maintenance therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS, calculated in each patient as the time from the date of treatment start to the date of first progression or death from any cause, whichever comes first. Subjects not having progressed or died by the end of the study will be censored at the last disease assessment date OS, calculated for each patient as the time from the date of treatment start to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive. Clinical Benefit, defined as proportion of patients with CR+PR+SD and without grade 3-4 adverse events after 12 weeks of maintenance treatment. Maximum toxicity grade experienced by each patient for each specific toxicity; frequency of patients experiencing adverse events that are recorded as grade 3-5 (also grade 2 for neurotoxicity); adverse events will be graded according to NCI CTC AE, version 4.03. Type and frequency of serious adverse reactions.;Timepoint(s) of evaluation of this end point: PFS, calculated in each patient as the time from the date of treatment start to the date of first progression or death from any cause, whichever comes first. OS, calculated for each patient as the time from the date of treatment start to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive. Clinical benefit: after 12 weeks of treatment | — |
Countries
Italy, Portugal, Spain
Contacts
Public ContactLaboratory of Methodology for Clini
IRCCS - Istituto di ricerche farmacologiche Maio Negri
Outcome results
None listed