Progression of an advanced (locally advanced or metastatic) Her2-negative breast cancer after anthracycline and/or taxane pretreatment MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Levact®
Product Name: Bendamustine
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: BENDAMUSTINE
CAS Number: 16506-27-7
Concentration unit: mg/ml mill
Sponsors
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The efficacy of a capecitabine plus bendamustine combination regimen in the treatment of Her2-negative advanced metastatic breast cancer, in terms of overall response rates (complete or partial Response) ;Secondary Objective: To determine the safety profile of a combination with capecitabine and bendamustine in terms of qualitative and quantitative toxicities from first study treatment dose until completion of study treatment due to progression or for any other reason. To evaluate the study population with respect to the following: clinical benefit (CR, PR or stable disease for at least 24 weeks), progression free survival (from treatment start until progression or death from any cause) and explorative the overall survival (from treatment start until death from any cause). To evaluate Quality of Life (QoL) status within the study population is captured using the EORTC QLQ-C30 standard questionnaire. Predefined subgroup analysis of triple-negative patients and hormone receptor positive patients in terms of response;Primary end point(s): Overall Response Rates (ORR) Primary outcome variable Overall tumor response rates (complete response (CR) or partial response (PR), determined by radiologic evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [23] ;Timepoint(s) of evaluation of this end point: Efficacy and safety will be evaluated following recruitment of the first 20 patients. Upon favorable results a further 20 patients will be recruited and efficacy and safety will be evaluated at end of the study. Last Subject Last Visit will be at final staging after end of treatment of last Patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival (PFS) Clinical benefit (CR, PR or stable disease for at least 24 weeks) Safety profile of a combination with capecitabine and bendamustine Quality of Life Secondary outcome variables Safety: qualitative and quantitative toxicities Overall survival Progression free survival Change in quality of life (measured with the global scale of the EORTC QLQ-C30, BR 23) from the time of screening up to the time of study end. Predefined subgroup analysis of triple-negative patients and hormone receptor positive patients in terms of Response.;Timepoint(s) of evaluation of this end point: Efficacy and safety will be evaluated following recruitment of the first 20 patients. Upon favorable results a further 20 patients will be recruited and efficacy and safety will be evaluated at end of the study. Last Subject Last Visit will be at final staging after end of treatment of last Patient. | — |
Countries
Austria
Contacts
Public ContactDr. Judith Schuster
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Outcome results
None listed