Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Capecitabine + Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative 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.

Detailed description: 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: 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

Relevance to patient case: not relevant