Study evaluating weekly oral vinorelbine versus weekly paclitaxel in a population of patients with advanced breast cancer.
- Conditions
- advanced breast cancer with estrogen receptor positive and HER2 negative.MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003530-16-FR
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 124
· Age superior or equal to 18 years
· Histologically confirmed adenocarcinoma of the breast;
· Documented locally recurrent or metastatic disease previously untreated by chemotherapy and not amenable to curative surgery or radiotherapy;
· Estrogen receptor positive disease determined by superior or equal to 10% positive stained cells for estrogen receptor by immunohistochemistry on the primary tumor or on metastatic site whichever the value of progesterone receptor;
· HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH or CISH negative) on the primary tumor or on metastatic site;
· Complete staging within 4 weeks prior to randomization;
· Must have measurable disease according to RECIST (version 1.1);
· 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 should have received at least one previous hormone therapy for breast cancer in any stage of the disease;
· Patients who have received adjuvant or neoadjuvant chemotherapy are allowed if relapsing more than 6 months after the end of chemotherapy;
· Patients may have received prior radiotherapy but a minimum of a 4 weeks interval must have elapsed;
· Karnofsky Performance Status superior or equal to 70%;
· Life expectancy superior or equal to 16 weeks;
· Adequate bone marrow, hepatic and renal functions as evidenced by the following:
- Haemoglobin superior or equal to 10 g/dL
- Absolute Neutrophil Count superior or equal to 1.5 x 109/L
- Platelet Count superior or equal to 100 x 109/L
- Total Bilirubin inferior or equal to 1.5 x ULN (ULN: Upper Limit of Normal)
- SGOT/SGPT inferior or equal to 2.5 x ULN
- Alkaline phosphatase < 5 x ULN
- Creatinine Clearance > 40 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 randomization 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 124
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 124
· Female is not eligible to enter the study if :
- pregnant or lactating
- with positive pregnancy test at inclusion;
· Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;
· Concomitant hormonal therapy for advanced 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;
· Prior treatment with chemotherapy in the metastatic setting;
· Patients with dysphagia, or inability to swallow the tablets;
· Other serious illness or medical conditions:
- Clinically significant cardiac disease
- Unstable diabetes
- Uncontrolled hypercalcemia
- Clinically significant active infections (current or in the last two weeks)
- Previous organ allograft
· Current peripheral neuropathy grade 2 according to NCI version 2 criteria;
· Participation in another clinical trial with any investigational drug within 30 days prior to randomization 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 or taxanes.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate, as a first-line chemotherapy, the disease control rate (DCR) of weekly oral vinorelbine as a single-agent versus weekly paclitaxel as a single-agent in estrogen receptor positive, HER2 negative patients with advanced breast cancer.;Secondary Objective: - to evaluate the response rate, duration of response, duration of stable disease, progression free survival, time-to-treatment failure and overall survival of both regimens<br>- to evaluate the safety profile in both study arms<br>- to assess the quality of life of patients;Primary end point(s): Disease control rate (DCR) ;Timepoint(s) of evaluation of this end point: Efficacy will be determined by the assessment of all lesions at baseline, then every 6 weeks until documented disease progression, unacceptable toxicity or patient’s refusal.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - to evaluate the response rate, duration of response, duration of stable disease, progression free survival, time-to-treatment failure and overall survival of both regimens<br>- to evaluate the safety profile in both study arms<br>- to assess the quality of life of patients.;Timepoint(s) of evaluation of this end point: Efficacy will be determined at baseline, then every 6 weeks until documented disease progression, unacceptable toxicity or patient’s refusal.<br><br>Clinical safety will be assessed at baseline, within each cycle, and at the end of the study<br><br>Quality of life assessment: questionnaires will be filled in at baseline before randomisation, then immediately before cycle 2, cycle 4, cycle 6 etc… and at the end of study treatment.