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 (GBG) Research

Status and phase

Completed

Phase 1

Conditions

Metastatic Breast Cancer

Treatments

Drug: Bendamustine

Study type

Interventional

Funder types

Other

Identifiers

NCT00661739

GBG 38

Details and patient eligibility

About

The aim of the study is to establish a feasible combination of bendamustine and paclitaxel in a weekly schedule. The two agents have different toxicity profiles and are well tolerated when given in a weekly fashion. The combination might be of special interest for elderly patients with hormone insensitive breast cancer

Enrollment

38 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 radiological and clinical tumor 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 hemoglobin ≥ 9 g/dl
Bilirubin within normal limits; evaluation of transaminases and alkaline phosphatase ≤ 5x upper normal limit
Serum creatinine ≤ 2.0 mg/dl
Normal left ventricular ejection fraction (LVEF) by echocardiogramme
Patients of childbearing potential, pregnancy test must be negative
If fertile effective contraception must be used throughout the study

Exclusion criteria

Known or suspected 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
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