Randomized, open-label, phase III study of RPR109881 IV every 3 weeks versus capecitabine (Xeloda®) tablets administered twice daily for 2 weeks in 3-week cycles in patients with progressive metastatic breast cancer after therapy with taxanes and anthracyclines

AVENTIS PHARMA S.A.,0 sites0 target enrollmentStarted: May 11, 2005Last updated: September 4, 2023

Conditions

Trial Snapshot

No summary available.

•1) Diagnosis of histologically or cytologically proven breast adenocarcinoma currently metastatic (TxNxMI) or locally recurrent and inoperable with attempted cure.
•2) All patients must have received an anthracycline and a taxane before entering the protocol.
•3) Patients must have completed all previous chemotherapy treatments.
•4) Evidence of measurable disease according to the definition of the Evaluation Criteria of the Response in Solid Tumors (RECIBI).
•5) Male or female patients at least 18 years of age.
•6) ECOG Performance Status (Eastern Cooperative Oncology Group) of 0.1, or 2.
•7) Patients must have resolved all the clinically significant toxic effects of any surgery, radiotherapy, cryotherapy, chemoembolization therapy, hormone therapy, immunotherapy.
•8) Adequate organic functioning.
•9) Patients must be postmenopausal, must have been surgically sterilized or must be using an effective contraceptive method.
•10) Patients (or their authorized legal representative) must agree to, sign and date an informed consent form.
•11) Patients must be willing and able to comply with planned visits, treatment plans, laboratory tests and other study procedures.

•1) History of any second malignancy with the exception of skin cancer of basal cells or squamous cells adequately treated, or carcinoma in situ of the cervix.
•2) A history of grade 3 hypersensitivity to taxanes, pyloropyrimidines, Polysorbate-80 or to compounds with similar chemical structures.
•3) The following treatments for breast cancer: Patients receiving> 1 adjuvant regimen, Patients receiving> 1 regimen of chemotherapy for breast cancer] mechastatic or relapse and Inoperable.
•4) Previous treatment with capecitabine or any analogue of taxanes.
•5) Concomitant treatment with potent cytochrome P450 3A4 inhibitors.
•6) Concomitant treatment in another clinical study or with any other treatment for cancer that includes chemotherapy, immunotherapy, hormone therapy, radiotherapy, chemoembolization therapy, cryotherapy.
•7) Concomitant treatment with trastuzumab [Herceptin®] is not allowed.
•8) Known cerebral or leptomeningeal disease.
•9) Any of the following conditions within the 6 months prior to randomization: myocardial infarction, severe / unstable angina, peripheral or coronary artery bypass graft surgery, clinically significant or cardiac arrhythmias.
•10) History of inflammatory bowel disease or chronic diarrhea.
•11) Peripheral neuropathy grade> 2.
•12) Another severe acute or chronic psychiatric or clinical condition, or abnormal laboratory significant values.

Sponsor

AVENTIS PHARMA S.A.,