A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

Patient who received vinorelbine in adjuvant setting.

Patient with a known hypersensitivity to oral vinorelbine, létrozole, Anastrozole or any of the excipients or others vinca-alcaloïdes. 3. Patient who received any prior anti-cancer therapy (including chemotherapy) for advanced disease with the exception of surgery.

Note:

Patients who received (neo) adjuvant therapy for breast cancer are eligible. Prior therapy with letrozole or anastrozole in the (neo) adjuvant setting is permitted if the disease free interval is greater than 24 months from the completion of treatment.

Patient has a concurrent malignancy or malignancy within 5 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervix cancer.

Patient with known CNS metastases.

Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

Patient with a known history of HIV infection (testing not mandatory)

Patient who any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in the clinical study (e.g. chronic pancreatitis, chronic active hepatitis, etc.)

Patient with active cardiac disease or a history of cardiac dysfunction including any of the following:

History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry History of documented congestive heart failure (New York Heart Association functional classification III-IV) Documented cardiomyopathy

Patient with peripheral neuropathy\>grade 2 CTCAE version 4.0

Patient who had major surgery within 14 days prior to starting study drug or has not recovered from major side effects

Patient who concurrently using other antineoplastic agents.

Patient who has received radiotherapy for palliation ≤ 2 weeks prior to randomization, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia) and/or from whom ≥ 30% of the bone marrow was irradiated.

Participation in another clinical trial with any investigational drug within 30 days prior to randomization and/or during the study.

Pregnancy or lactating patients

Patient with history of surgical resection extended to the stomach or small intestine

Patient with a severe infection current or recent (within 2 weeks)

Patient needs long-term oxygen therapy

Patient with rare hereditary problems of fructose intolerance

In combination with the vaccine against yellow fever

What this study is about