Therapy for breast cancer

Phase 1

Conditions: Progression of an advanced (locally advanced or metastatic) Her2-negative breast cancer after anthracycline and/or taxane pretreatment
MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-005593-64-AT

Lead Sponsor: Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 40

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 neoadjuvant or adjuvant)
Life expectancy of at least 12 weeks
Performance status 0-2
Adequate hematology, liver and renal function:
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 and ALT = 3 x ULN 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 capacitabine and bendamustine or their excipients
Pretreatment with capecitabine (pretreatment with infusional 5-FU in the adjuvant or neoadjuvant setting is allowed) or bendamustin
Treatment with sorivudine or derivates e.g. brivudin (Mevir©) within the last 4 weeks before and during study treatment with capecitabine