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

• Conditions: Breast cancer with bone metastases previously treated by a hormone therapy.; MedDRA version: 13.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-02
• Last Update Posted: 21 September 2015

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 >or=10% 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-) or unknown status (exclusively in case of impossibility of testing HER2 status) on the primary tumor or on metastatic site;
- 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.