| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00703326 | Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer | PHASE3 | COMPLETED | 1,144 | — | — | Aug 6, 2008 | Nov 19, 2020 | Dec 6, 2021 | 232 | United States, Australia +21 |
| NCT01427933 | A Study of Ramucirumab (IMC-1121B) in Combination With Eribulin Versus Eribulin Alone in Participants With Breast Cancer | PHASE2 | COMPLETED | 141 | — | — | Nov 1, 2011 | Jun 1, 2014 | Feb 6, 2017 | 52 | United States |
| NCT01256567 | A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer | PHASE1 | COMPLETED | 7 | — | — | Dec 1, 2010 | Feb 1, 2013 | Jun 18, 2014 | 4 | Japan |
PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who neither progressed nor died were censored the day of their last radiographic tumor assessment if available or date of randomization if no post initiation radiographic assessment was available. If death or PD occurred after ≥2 missing radiographic visits, censoring occurred at date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.
Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification. DLT=G4 neutropenia \>7days; G ≥3 neutropenia with fever ≥38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G ≥3 thrombocytopenia with bleeding requiring platelets; G≥3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G≥2 hyperbilirubinemia ≥5 days; QTc \>500 milliseconds (ms) or increase ≥100 ms or arrhythmia; G≥4 or uncontrollable hypertension; G≥3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay \>2 weeks due to toxicity.
| Arm | Type | Description |
|---|---|---|
| ramucirumab (IMC-1121B) + docetaxel | EXPERIMENTAL | - |
| placebo + docetaxel | PLACEBO_COMPARATOR | - |
| Ramucirumab and Eribulin | EXPERIMENTAL | Ramucirumab 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle |
| Eribulin Monotherapy | ACTIVE_COMPARATOR | Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle |
| ramucirumab and docetaxel combination | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ramucirumab (IMC-1121B) | BIOLOGICAL | 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 | DRUG | Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle. |
| Placebo | OTHER | Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle. |
| Eribulin | DRUG | Administered intravenously |
| Ramucirumab | BIOLOGICAL | Ramucirumab administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks. |
Inclusion Criteria: * Participant is able to provide signed informed consent * Participant is female and ≥ 18 years of age or older if required by local laws or regulations * Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-rec...