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

• Conditions: 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: 13.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2004-004880-31-DE
• Lead Sponsor: German Breast Group Forschungs GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-08
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified