A randomized phase II trial of metronomic oral vinorelbine plus cyclophosphamide and capecitabine (VEX) versus weekly paclitaxel as first or second-line treatment in patients with ER-positive/HER2-negative advanced or metastatic breast cancer - METEORA II

International Breast Cancer Study Group (IBCSG)0 sites160 target enrollmentJanuary 30, 2018

Overview

No summary available.

Registry

who.int

Start Date

January 30, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

International Breast Cancer Study Group (IBCSG)

•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,

•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.