advanced breast cancer with estrogen receptor positive and HER2 negative. MedDRA version: 14.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · 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 (for patients receiving oral vinorelbine) or 6 months (for patients receiving paclitaxel) 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 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
Exclusion criteria
Exclusion criteria: · 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - to evaluate the safety profile in both study arms - 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
| Measure | Time frame |
|---|---|
| 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 - to evaluate the safety profile in both study arms - 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. Clinical safety will be assessed at baseline, within each cycle, and at the end of the study 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. | — |
Countries
Argentina, Austria, Brazil, France, Italy, Poland, Spain, Switzerland
Contacts
Public ContactGustavo Villanova
Pierre Fabre Medicament
Outcome results
None listed