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

• Conditions: Metastatic breast cancer patients after failure to anthracyclines, taxanes and capecitabine.; Classification code 10055113

• Registration Number: EUCTR2004-000572-14-BE
• Lead Sponsor: Aventis Pharmaceuticals, Inc. (a subsidiary of sanofi-aventis group)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-16
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

-Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic or locally recurrent and inoperable. Patients with previously treated histo/cytologically confirmed disease who develop clinical or radiological evidence of metastatic disease do not require separate confirmation of the metastatic disease.

-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 have received a standard dose of anthracycline, taxane and capecitabine expected to have potentially resulted in a response.

-Evidence of measurable disease as defined by RECIST. Measurable lesions are lesions that can be accurately measured in at least one dimension with longest diameter superior or equal to 20mm. With spiral CT scan ,lesion must be superior or equal to 10mm in at least one dimension (slice thickness= 5-8 mm).

-Completion of all prior chemotherapy, immunotherapy (including trastuzumab [Herceptin®]), targeted non-cytotoxic therapy, and radiotherapy superior or equal to 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 disease being evaluated for efficacy in this protocol. Patients may start or continue to receive bisphosphonate therapy as clinically indicated.

-ECOG performance status of 0,1 or 2.

-Patients who received chemotherapy in the adjuvant setting must not have received more than two previous chemotherapy regimens ( ie, a single or a combination of chemotherapy agents given until documented disease progression or relapse) for metastatic or locally recurrent and inoperable breast cancer. Patients who did not receive chemotherapy in the adjuvant setting must not have received more than three previous chemotherapy regimens for metastatic or locally recurrent and inoperable breast cancer. A chemotherapy regimen is defined as a single or a combination of chemotherapy agents given until documented disease progression or relapse.

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

-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. Inclusion of any other in situ cancer must be discussed with the sponsor. 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 ,erythromycin, 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 treatment with Abraxane® (nanoparticle albumin-bound paclitaxel) is permitted.

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

-HER2-positive patients may participate in this trial. Concurrent treatment with trastuzumab (Herceptin®) is not permitted.

-Known symptomatic brain or leptomeningeal involvement with cancer. Patients with a history of symptomatic brain involvement with cancer (i) must have had these lesions previously surgically removed or irradiated; (ii) must not be treated currently with corticosteroids; and (iii) must have documentation that the lesions are stable or improving by CT or MRI scan performed at least 3 months apart. For such patients, a baseline CT or MRI scan must be obtained less than or equal to 21 days prior to the first treatment dose on study. 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