Breast cancer with bone metastases previously treated by a hormone therapy. MedDRA version: 12.1 Level: LLT Classification code 10027475 Term:
Conditions
Interventions
Trade Name: NAVELBINE® soft capsule
Product Name: NAVELBINE® ORAL
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: VINORELBINE
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women with: · Age > or =18 years; · Histologically confirmed adenocarcinoma of the breast; · Documented bone involvement +/- other non visceral metastatic disease previously untreated by chemotherapy; · Hormone receptor positive disease determined by ³10% positive stained cells for oestrogen and/or progesterone receptor by immunohistochemistry on the primary tumor or on metastatic site; · HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site; · Complete staging within 4 weeks prior to registration; · Women of childbearing potential must be using a medically accepted method of contraception to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised; · Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment; · Patients who have received adjuvant or neoadjuvant chemotherapy are allowed if relapsing more than 6 months after the end of chemotherapy; · Patients should have received at least one hormone therapy for breast cancer in any given previous stage of the disease; · Patients must be under treatment by a bisphosphonate since at least one month before entering the study; · Patients may have received prior radiotherapy but a minimum of a 4 weeks interval must have elapsed; · Karnofsky Performance Status > or = 70%; · Life expectancy > or =16 weeks; · Adequate bone marrow, hepatic and renal functions as evidenced by the following: - Haemoglobin > or = 10 g/dL; - Absolute Neutrophil Count > or =1.5 x 109/L; - Platelet Count > or = 100 x 109/L; - Total Bilirubin 50 mL/min; calculated using the Cockroft and Gault formula. · Absence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be assessed with the patient before registration in the trial; · The patient must have access to social insurance if applicable according to the local regulations. · The patient must give written (personally signed and dated) informed consent before completing any study-related procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Female is not eligible to enter the study if: - pregnant or lactating - with positive pregnancy test at inclusion · Patients with visceral metastatic involvement (that include at least one of the following: liver, lung, pleura, heart, peritoneum, CNS, spleen and suprarenal glands); · Patients with symptoms suggesting CNS involvement or leptomeningeal metastases; · Concomitant hormonal therapy for metastatic breast cancer; · Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine (Navelbineâ Oral); · Prior treatment with chemotherapy in the metastatic setting; · Patients previously treated with vinorelbine in the early-stage setting; · Patients with dysphagia, or inability to swallow the tablets; · Other serious illness or medical conditions: - Cardiac disease; - Unstable diabetes; - Uncontrolled hypercalcemia; - Clinically significant active infections; - Previous organ allograft · Current peripheral neuropathy > or = grade 2 according to NCI criteria; · Participation in another clinical trial with any investigational drug within 30 days prior to registration and/or during the study, · History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix. · With known hypersensitivity to vinca alkaloids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ·To determine the Progression-Free Survival (PFS) of oral vinorelbine as a single agent in patients with hormone receptor positive breast cancer with bone metastases previously treated by a hormone therapy.;Secondary Objective: ·To assess the safety profile of treatment .To evaluate other efficacy parameters: - Clinical Benefit Rate (CR + PR + SD >or= 24 weeks) - Duration of disease control - Time to treatment failure - Overall survival;Primary end point(s): The main endpoint of this study is to determine the Progression-Free Survival (PFS) of oral vinorelbine as a single agent in patients with hormone receptor positive breast cancer with bone metastases previously treated by a hormone therapy. | — |
Countries
Austria, France, Italy, Spain
Outcome results
None listed