A clinical study comparing the combination of oral chemotherapy medications vinorelbine plus cyclophosphamide and capecitabine taken orally at lower doses on a continuous regular schedule with paclitaxel given by injection once a week in patients with advanced breast cancer or breast cancer that has spread to other body systems.
- Conditions
- ER-positive/HER2-negative locally advanced or metastatic (stage IV)breast cancerMedDRA version: 20.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002200-39-IT
- Lead Sponsor
- International Breast Cancer Study Group (IBCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 160
•Histologically or cytologically confirmed HER2-negative locally advanced or metastatic (stage IV) breast cancer.
•Maximun of one prior line of chemotherapy for advanced or metastatic brest cancer
•Measurable or non-measurable, but radiologically evaluable (except for skin lesions), disease according to RECIST 1.1 criteria.
•Female aged 18 years or older.
•Life expectancy > 3 months.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
•ER-positive disease by local laboratory, determined on most recent available tissue (latest biopsy of metastatic lesion, otherwise prior biopsy or surgical specimen).
•If previously treated with a taxane in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been > 12 months (> 365 days).
•Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
•Normal hematologic status,
-Absolute neutrophil count =1000/mm3
(1.0 × 109/L)
-Platelets = 100 × 109/L
-Hemoglobin = 9 g/dL (= 90 g/L)).
•Normal renal function: serum creatinine = 1.5 ULN or calculated creatinine clearance = 50mL/min according to the Cockcroft-Gault formula.
•Normal liver function:
-Serum total bilirubin = 1.5 × upper limit of normal (ULN). In the case of known Gilbert’s syndrome, a higher serum total bilirubin (< 3 × ULN) is allowed
-AST and ALT = 3 × ULN; if the patient has liver metastases, ALT and AST must be = 5 × ULN.
•Women of child bearing potential must have documented negative pregnancy test within 2 weeks prior to randomization and agree to acceptable birth control during and up to 6 months after trial therapy.
•Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to starting screening procedures and randomization.
•The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
•More than one prior line of chemotherapy for advanced or metastatic breast cancer
•More than 2 lines of previous endocrine therapy for locally advanced or metastatic breast cancer.
•Known active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with history of CNS metastases or spinal cord compression are eligible if they are clinically and radiologically stable for at least 4 weeks before first dose of trial treatment and have not required high-dose steroid treatment in the last 4 weeks).
•Peripheral neuropathy grade 2 or higher (CTCAE version 4.0).
•Significant uncontrolled cardiac disease (i.e. unstable angina, myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
•Pregnant or lactating.
•Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
•Any concurrent condition which in the Investigator’s opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
•Contraindications or known hypersensitivity to the trial medication or excipients.
•The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method