MEtronomic TrEatment Option in Advanced bReast cAncer (NCT02954055) | Clinical Trial Compass
CompletedPhase 2
MEtronomic TrEatment Option in Advanced bReast cAncer
Italy140 participantsStarted 2017-09-13
Plain-language summary
This is a multi-center, randomized phase II trial that will randomise women with ER-positive, HER2-negative (Human Epidermal Growth factor Receptor 2-negative) metastatic or locally relapsed breast cancer in a ratio of 1:1 to receive a metronomic regimen of vinorelbine plus cyclophosphamide and capecitabine, or the conventional paclitaxel monotherapy.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed HER2-negative locally advanced or metastatic (stage IV) breast cancer.
* Maximum of one prior line of chemotherapy for advanced or metastatic breast 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 ≥ 50 mL/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.
* Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 3 × ULN; if the patient …
What they're measuring
1
Time to Treatment Failure (TTF) Compared Between Treatment Groups.
Timeframe: Assessed at the start of every 4-week (28-day) treatment cycle from randomization to the end of treatment date or discontinuation; median follow-up was 29 months, with a minimum of 0.2 months and maximum of 48.5 months.