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Keep this study
Lead
Arbeitsgemeinschaft medikamentoese Tumortherapie
40 eligible patients will be enrolled. A two-stage design efficacy and safety of bendamustine and capecitabine will be evaluated following recruitment of the first 20 patients. Upon favorable results a further 20 patients will be recruited to reach the target population of 40 evaluable patients.
Pretreatment for eligible patients must include anthracyclines and/or taxanes.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent
Female patients, age ≥ 18 years (women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception)
Advanced or metastatic Her2-negative breast cancer, histologically confirmed
At least one measurable lesion according to RECIST criteria (Version 1.1)
Documented disease progression
Patients with progression after anthracycline and/or taxane treatment(palliative or adjuvant)
Life expectancy of at least 12 weeks
Performance status 0-2
Hematologic:
* ANC (absolute neutrophil count) ≥ 1.5 x 109/L
* Hemoglobin ≥ 9 g/dL
* Platelets ≥ 100 x 109/L
Liver Function:
* Albumin ≥ 2.5 g/dL
* Serum bilirubin ≤ 2 mg/dL
* AST (Aspartate aminotransferase) and ALT (Alanine aminotransferase) ≤ 3 x ULN (Upper limit of Normal) without liver metastases
Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent
Radiation of the target lesion within the last 4 weeks
Active bacterial, viral or fungal infection
Patients with clinically apparent brain metastases
Known Positivity for HIV
Positivity for Hepatitis B or C
History of other malignancy; patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
Concurrent cancer therapy (chemotherapy, immunotherapy, antihormonal or biologic therapy) or concurrent treatment with an investigational drug
Antihormonal therapy must have been discontinued prior to start of treatment (if possible at least 3 weeks before)
Known hypersensitivity to the study drugs capecitabine and bendamustine or their excipients
Pretreatment with capecitabine (pretreatment with infusional 5-FU (Fluorouracil) in the adjuvant or neoadjuvant setting is allowed) or bendamustine
