Status:
COMPLETED
Capecitabine + Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer
Lead Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 disea...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01891227
Start Date
August 9 2013
End Date
March 15 2018
Last Update
November 7 2018
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Hämatologie und Onkologie/Interne E, LKH Feldkirch
Feldkirch, Austria, A-6807
2
Universitätsklinik f. Frauenheilkunde und Geburtshilfe, Klin. Abt. f. Gynäkologie
Graz, Austria, 8036
3
Universitätsklinik f. Innere Medizin, Klin.Abt. f. Onkologie
Graz, Austria, 8036
4
Univ.-Klinik f. Frauenheilkunde; Klinische Abt. f. Gynäkologie u. Geburtshilfe
Innsbruck, Austria, A-6020