None listed
Conditions
Interventions
Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 mi
Sponsors
ImClone LLC,
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Participant is able to provide signed informed consent 2) Participant is female and ≥ 18 years of age or older if required by local laws or regulations 3) Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis 4) Participant has measurable and/or non-measurable disease 5) Participants´ primary and/or metastatic tumor is human epidermal growth factor receptor 2 (HER2)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC) 6) Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization
Exclusion criteria
Exclusion criteria: 1) Participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that she has been disease free for > 3 years. 2) Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80. 3) Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80. 4) Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80. 5) Participant has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (such as, pelvic or abdominal radiation) within 30 days prior to randomization
Countries
Argentina, Brazil, Germany, Mexico, New Zealand, Peru, United States
Outcome results
None listed