Metastatic Breast Cancer
Conditions
Keywords
palliative, Breast cancer, metastatic, Bendamustine, phase I
Brief summary
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
Interventions
DRUGBendamustine
Dose-level Bendamustine(mg/m²): I:50; II:60; III:60; IV:70; V:70 Dose-level Paclitaxel (mg/m²): I:60; II:60; III:80; IV:80; V:90 Treatment will be given on day 1,8,15 and repeated on day 29. When the recommended dose has been determined a total of 48 pts will be treated at this dose level.
Sponsors
GBG Forschungs GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The phase I part of the trial should evaluate the maximal tolerated dose (MTD) for the combination of bendamustine with paclitaxel. | end of cycle 2 of the 6th patient of the assumed highest dose level |
Secondary
| Measure | Time frame |
|---|---|
| To determine the objective response rate (phase II part) | EOT last patient (phase II part) |
Outcome results
None listed