capecitabine + bendamustine in women with pretreated locally advanced or metastatic her2-negative breast cancer

Conditions: Breast Cancer

Summary: patients with pretreated, her2-negative, advanced breast cancer will receive chemotherapy with capecitabine and bendamustine for a maximum of eight cycles and afterwards capecitabine alone until disease progression or unacceptable toxic effects. safety assessments will be conducted in 3-weekly intervals, efficacy assessments (ct or mri) will be conducted every 9 weeks. aim of this study is to determine whether treatment with capecitabine in combination with bendamustine is efficacious and safe.

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.

Eligibility criteria:
inclusion criteria: * 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 * 5 x uln if documented liver metastases * renal function: * serum creatinine ≤ 1.5 mg/dl or calculated creatinine clearance ≥ 40 ml/min exclusion criteria: * pregnant or lactating women * 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 * treatment with sorivudine or derivates e.g. brivudin (mevir©) within the last 4 weeks before and during study treatment with capecitabine

Keywords: bendamustine capecitabine pretreated her2 negative advanced breast cancer metastatic breast cancer anthracycline pretreatment taxane pretreatment