Phase II multicenter, open label, non-randomized study of intravenous RPR109881 q 3 weeks in patients with metastatic breast cancer progressing after therapy with anthracyclines, taxanes, and capecitabine. - Not applicable

Phase 1

Conditions: Metastatic Breast Cancer Patients after failure to Anthracyclines, Taxanes and Capecitabine.
Classification code 10055113

Registration Number: EUCTR2004-000572-14-ES

Lead Sponsor: Aventis Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 162

Inclusion Criteria

. Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic (TxNxM1) or locally recurrent and inoperable (T4NxM0).

. Patients must have been previously treated with an anthracycline, taxanes (docetaxel and/or paclitaxel), and capecitabine. These treatments may have been given in the adjuvant or metastatic setting, separately or combined.

. Patients must not have received more than two previous chemotharapy regimens for metastatic or locally recurrent and inoperable breast cancer.

. Evidence of measurable disease as defined by RECIST.

. Completion of all prior chemotherapy, immunotherapy (including trastuzumab [Herceptin®]), targeted non-cytotoxic therapy, and radiotherapy more or equal 3 weeks prior to first treatment dose on study. Prior treatment with radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies did not affect the areas of measurable or non-measurable disease being evaluated for efficacy in this protocol. Patients on stable doses of bisphosphonate therapy for at least 90 days prior to first treatment dose on study may continue such therapy.

. ECOG (Eastern Cooperative Oncology Group) performance status of 0,1 or 2.

Are the trial subjects under 18?
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

. History of any second malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri. Patients with adequately treated contralateral breast cancer which has been disease-free for more than 5 years prior to first treatment dose on study are eligible.

. Concurrent treatment with other anti-cancer therapy, including chemotherapy, immunotherapy (including trastuzumab [Herceptin®]), hormonal therapy, radiotherapy, chemoembolization therapy, cryotherapy, targeted therapy, or patients planning to receive these treatments.

. Concurrent treatment with potent inhibitors of cytochrome P450 3A4, such as ketoconazole, itraconazole, and clarithromycin, or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required before first treatment dose on study.

. Prior treatment with epothilones or with non-approved tubulin-interacting agents.

. Prior participation in any other trials that involve RPR109881 with a survival endpoint to avoid compromising the results of such trials.

. HER2-positive patients who are candidates for Herceptin®.

. Known symptomatic brain or leptomeningeal involvement with cancer. Patients with a history of symptomatic brain or leptomeningeal involvement with cancer (i) must have had these lesions previously surgically removed or irradiated; (ii) are not being treated currently with corticosteroids; and (iii) have had documentation that the lesions are stable or improving by CT or MRI scan performed at least 3 months apart. CT or MRI scan of the brain is required only in case of clinical suspicion of central nervous system involvement. Patients with asymptomatic untreated brain lesions are not excluded.

. Known human immunodeficiency virus (HIV) infection currently requiring therapy, or acquired immunodeficiency syndrome (AIDS)-related illness.

. Patients who are pregnant or breastfeeding.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the objective response rate of RPR109881 administered as a 1-hour infusion every 3 weeks in patients with metastatic breast cancer relapsing or progressing after therapy with anthracyclines, taxanes, and capecitabine.;Primary end point(s): The primary efficacy variable is the Response Rate (RR) defined as the proportion of patients with confirmed CR or confirmed PR, defined by RECIST criteria, relative to the total number of patients in the analysis population.;Secondary Objective: ·To assess the safety and tolerability of RPR109881 in this patient population.<br>·To assess the impact of RPR109881 on pain control and analgesic use.<br>·To assess the impact of RPR109881 on the maintenance of performance status.<br>·To determine the effect of RPR109881 on clinical benefit as assessed by time to tumor response, duration of response, time to tumor progression, and overall survival.<br>

Secondary Outcome Measures

Name	Time	Method

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