A multi-centre phase I-II study to investigate the combination of bendamustine with weekly paclitaxel as first or second line therapy in patients with metastatic breast cancer MedDRA version: 13.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Ribomustin
Pharmaceutical Form: Powder for solution for infusion
Other descriptive name: Bendamustine
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentr
Sponsors
German Breast Group Forschungs GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures; • Pathological confirmed primary carcinoma of the breast. • Locally advanced or metastatic disease • Up to one previous palliative chemotherapy that did not contain docetaxel or paclitaxel. Previous adjuvant treatment with taxanes is allowed when the last application of the taxane was given at least 1 year before entering the trial. • Patients must have either measurable or non-measurable lesions according to the WHO criteria • At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiated field or there must be pathological proof of progressive disease. • Complete radiology and tumour assessment within 4 weeks prior to registration performed as clinically indicated; • Karnofsky-Index =60%, • Age =18 years • Absolute neutrophil count =1,500 cells/µl, platelets =100,000/µl, and haemoglobin =9g/dl • Bilirubin within normal limits; evaluation of transaminases and alkaline phosphatase = 5x upper normal limit • Creatinine = 2.0mg/dl • Normal left ventricular ejection fraction (LVEF) by echocardiogramme • Patients with childbearing potential, pregnancy test must be negative • If fertile effective contraception must be used throughout the study 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known hypersensitivity reaction to the investigational compounds or incorporated substances; • Concurrent immunotherapy or hormonal treatment for cancer (Bisphosphonates may be continued) • Symptomatic parenchymal brain metastases not responding to treatment • Life expectancy less than 3 months • Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study • Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) • Concurrent treatment with other experimental drugs or any other anti-cancer therapy within the last 28 days; • History of congestive heart failure or other significant uncontrolled cardiac disease • Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the maximum tolerated dose of the combination of bendamustine and weekly paclitaxel (phase I part) • To determine the time to progression achievable with the recommended dose of this combination (phase II-part) ;Secondary Objective: • To determine the objective response rate (phase II-part) • To determine the safety and tolerability of the combination • To determine the dose-limiting toxicity (DLT) (grade IV haematological toxicities or grade III non-haematological toxicities) ;Primary end point(s): • the maximum tolerated dose of the combination of bendamustine and weekly paclitaxel (phase I part) • the time to progression achievable with the recommended dose of this combination (phase II part) | — |
Countries
Germany
Outcome results
None listed