Metastatic breast cancer MedDRA version: 19.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Navelbine 30mg
Product Name: Nabelvine
Product Code: SUB00069MIG
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: VIN
Sponsors
Asociación Terapéutica Investigación Oncológica (ATRIO)
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Having voluntarily given informed consent before performing the specific assay procedures. 2. Women aged =18 years. 3. MMC (stage IV) and HER2 negative histologically determined in the local laboratory. HER2 negative must have been determined by immunohistochemistry (IHC) or in situ hybridization when the HER2 / CEP17 ratio is =65
Exclusion criteria
Exclusion criteria: 1. Patients who have received more than one line of chemotherapy for metastatic disease. 2. Patients who have received first-line chemotherapy without taxanes for metastatic disease. 3. Patients with positive HR with hormone sensitivity criteria that: a. They have not received prior treatment for in metastatic disease with endocrine therapy. b. They have gone to a neo / adjuvant endocrine therapy after more than 12 months of completion. 4. Not measurable or evaluable disease at the start of chemotherapy in first-line. 5. Progression disease during first-line taxane-based chemotherapy. 6. Inclusion of the patient beyond 6 weeks of completion of treatment with taxanes. 7. Unavailability of the evaluation of tumor response after the last cycle taxane chemotherapy administered. 8. Intention to maintain treatment with bevacizumab or any other antidiana agent during the study. 9. Active antineoplastic treatment within 42 days prior to randomization (Except treatment with taxane ± another drug in combination as an anthracycline). 10. Brain metastases or leptomeningeal metastasis. performing a CT for checking the presence of these lesions is not necessary, except clinically suspected disease in the central nervous system (CNS) by the investigator. 11. Pregnant women, breast feeding or with a positive pregnancy test in the visit in the selection period; Women of childbearing potential and sexually active are unwilling to use adequate contraception (such as oral contraceptives, intrauterine device or method of contraceptive barrier with spermicide or surgical sterilization) during the study and up to 3 months after administration of the last dose of study treatment. 12. Use of any drug / investigational product or participation in another clinical trial simultaneously or within 28 days prior to randomization. 13. Peripheral neuropathy grade> 2 according to the criteria of the NCI-CTCAE version 4.0. 14. Previous radiation therapy in =30% of bone marrow or termination thereof or without full recovery of toxicities that may have experienced during radiation therapy given 30 days prior. 15. Patients with the diagnosis of other malignancies during the 5 years prior to inclusion in the study, despite having been adequately treated (except non-melanoma skin cancer and in situ cervical or colon carcinoma, adequately treated). 16. Any uncontrolled systemic disease such as heart disease, lung disease or clinically significant metabolic disease, severe infection, etc. 17. Inability to swallow tablets or reduction prior history of stomach or small intestine, or gastrointestinal absorption disorders that may interfere with the oral administration of the treatment under study. 18.- hereditary fructose intolerance. 19. Known hypersensitivity to study drug or other drugs of similar chemical structure. 20. Patients requiring treatment with strong inhibitors or inducers of CYP3A4 such as ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, rifampin or phenytoin, etc. (Annex 4). 21. Any major surgery or significant traumatic injury within 28 days prior to randomization, or for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate progression-free survival of patients treated with oral metronomic vinorelbine versus best supportive treatment after gaining control of the disease with a chemotherapy regimen based on first-line taxane (minimum 4 cycles); Secondary Objective: 1. To Evaluate and to compare the objective response rate , the rate of disease control and clinical benefit rate obtained 2. To evaluate and to compare the duration of response and duration of disease control. 3. To Evaluate and to compare the time to treatment failure in both treatment arms . 4. To evaluate and to compare overall survival. 5. To evaluate the parameters of response and survival depending on the type of supportive treatment received and compare the results with metronomic oral vinorelbine. 6. To evaluate and to compare the parameters of response and survival of different population subgroups based on stratification criteria . 7. To evaluate and to compare the safety and tolerability of treatment with metronomic oral vinorelbine and supportive treatment . ;Primary end point(s): Progression-free survival, defined as the time from randomization to oral vinorelbine in metronomic or best supportive treatment until disease progression or death from any cause in both treatment arms.;Timepoint(s) of evaluation of this end point: Disease progression or death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Objective Response Rate, defined as the proportion of patients achieving an objective response (CR or PR) as best overall response, according to RECIST v1.1 criteria. 2. Rate of disease control, defined as the proportion of patients achieving an objective response (CR or PR) or an EE for at least 16 weeks as best overall response by RECIST. 3. Clinical benefit rate, defined as the proportion of patients achieving an objective response (CR or PR) or EE as best overall response, based on RECIST, maintained for at least 24 weeks. 4. Duration of response, defined as the time elapsed since the documentation obtained the first response (CR or PR) to the documentation of disease progression or death of the patient, whichever comes first. 5. Duration of disease control, defined as the time from the documentation of the first CR, PD or SD to documentation of disease progression or death of the patient time, whichever comes first in patients who have had CR, PD or SD for at least 16 weeks as best answer. 6. Duration of clinical benefit , defined as the time from the documentation of the first CR, PD or SD to the documentation of disease progression or death of the patient, whichever comes first , in patients who have had RC , PD or SD, as best response for at least 24 weeks. 7. Time to treatment failure, defined as the time from randomization to treatment discontinuation or addition of a new treatment time for any reason, including disease progression, treatment toxicity or death of the patient. 8. Overall survival, defined as the time from randomization of the patient until the death of the same from any cause. 9. ORR, CBR, RDC, DR, DDC, DCB, TTF, PFS and OS in patients with positive HR receiving endocrine treatment and which do not receive endocrine therapy and best supportive care. 10. ORR, CBR, RDC, DR, | — |
Countries
Spain
Contacts
Public ContactMamen Jiménez
Dynamic S.L.
Outcome results
None listed