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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Bendamustine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Singular Arm<br>Bendamustine treatment | Drug: Bendamustine<br>* 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.<br>* Other names: Ribomustine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the objective response rate (phase II part) |  | EOT last patient (phase II part) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliative, Breast cancer, metastatic, Bendamustine, phase I