A multicentre 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 - Rita

German Breast Group Forschungs GmbH0 sites60 target enrollmentDecember 8, 2004

Overview

No summary available.

Registry

who.int

Start Date

December 8, 2004

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

German Breast Group Forschungs GmbH

•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

•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