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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Capecitabine will be dosed at 1000mg/m2 twice daily for 14 days, followed by a 7-day rest period for a total cycle time of 21 days (until disease progression or unacceptable toxic effects).
Bendamustine 80mg/m2 will be administered on day 1 and 8 of a three week cycle (for a maximum of eight cycles).
Hämatologie und Onkologie/Interne E, LKH Feldkirch
Feldkirch, Austria
Universitätsklinik f. Frauenheilkunde und Geburtshilfe, Klin. Abt. f. Gynäkologie
Graz, Austria
Universitätsklinik f. Innere Medizin, Klin.Abt. f. Onkologie
Graz, Austria
Univ.-Klinik f. Frauenheilkunde; Klinische Abt. f. Gynäkologie u. Geburtshilfe
Innsbruck, Austria
KH Barmh. Schwestern Linz, Innere Medizin I Hämatologie/Onkologie
Linz, Austria
Kepler Universitätsklinikum, Med Campus III, Klinik f. Interne 3 - Schwerpunkt Hämatologie u. Onkologie
Linz, Austria
Universitätsklinik für Innere Medizin III
Salzburg, Austria
Landeskrankenhaus Steyr, Interne Medizin II
Steyr, Austria
Efficacy of capecitabine + bendamustine combination regimen
Overall response rates (complete or partial response, determined by radiologic evaluation according to Response Evaluation Criteria in Solid Tumors - RECIST (Response Evaluation Criteria In Solid Tumors) Version 1.1) The study will be stopped after 20 patients if there are fewer than four subjects with an overall response of CR (complete response) or PR (partial response). If there are at least four responses an additional 20 subjects will be enrolled and treated till a maximum of 40 subjects. The regimen is concluded to be effective if 13 or more responses out of 40 are observed at the end of the trial. The last patient is expected to enter the study in Q1 2015, following a 24 month recruitment period. Last Subject Last Visit will be at final staging after end of treatment of last patient. Follow-up after Last Subject Last Visit will be conducted according to local standard of care thereafter, and is not part of study procedures.
Time frame: At baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years
Safety profile of a combination with capecitabine and bendamustine
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. All safety analyses will be based on the safety population, defined as subjects who received at least one dose of the study medication and have at least one post-treatment safety assessment available. The safety population will be used for all safety and tolerability analyses including demographic data, vital signs, laboratory data and adverse events.
Time frame: From treatment start until 28 days after last study treatment; expected study duration 3 years
Clinical benefit
CR, PR or stable disease for at least 24 weeks
Time frame: Baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years
Progression free survival
Time frame: Baseline + every 9 weeks until progression; expected study duration 3 years
Overall survival
explorative, from treatment start until death from any cause
Time frame: During complete study treatment, after study treatment every 3 months until end of complete study; expected study duration 3 years
Quality of life
To evaluate Quality of Life (QoL) status within the study population using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ (Quality-of-life-questionnaire)-C30 standard questionnaire and the BR23 module (module for breast cancer patients)
Time frame: Baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years
Predefined subgroup analysis in terms of response
Predefined subgroup analysis of triple-negative patients and hormone receptor positive patients in terms of response
Time frame: Baseline + every 9 weeks until progression + at end of study treatment+every 3 months after end of treatment until end of study; expected study duration 3 years
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