Phase II study evaluating oral vinorelbine as a single agent in patients with hormone receptor breast cancer with bone metastases previously treated by a hormone therapy

Phase 1

• Conditions: Breast cancer with bone metastases previously treated by a hormone therapy.; MedDRA version: 12.1Level: LLTClassification code 10027475Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2009-014497-18-FR
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-20
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 66

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 < ULN (ULN: Upper Limit of Normal);
-SGOT/SGPT < or = 2.5 x ULN,
-Alkaline phosphatase < 5 ULN
-Creatinine Clearance > 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

·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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>.To evaluate other efficacy parameters:<br>-Clinical Benefit Rate (CR + PR + SD >or= 24 weeks)<br>-Duration of disease control<br>-Time to treatment failure<br>-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.