Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer
A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients With HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer
6 other identifiers
interventional
1,144
23 countries
232
Brief Summary
The objective of this study is to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated participants with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Aug 2008
Longer than P75 for phase_3 breast-cancer
232 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2008
CompletedFirst Posted
Study publicly available on registry
June 23, 2008
CompletedStudy Start
First participant enrolled
August 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2013
CompletedResults Posted
Study results publicly available
June 17, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2020
CompletedDecember 6, 2021
November 1, 2021
4.7 years
June 20, 2008
May 16, 2014
November 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
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.
Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 56 months)
Secondary Outcomes (8)
Overall Survival (OS)
Randomization to death or until data cutoff of 29-May-2015 (up to 82 months)
Time to Progression (TTP)
Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months)
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months)
Duration of Response
Date of first CR or PR to PD or death or until data cutoff date of 31-Mar-2013 (up to 56 months)
Total Functional Assessment of Cancer Therapy-Breast (FACT-B): Change From Baseline to End of Therapy
Baseline, End of Therapy or until data cutoff of 31-Mar-2013 (up to 56 months)
- +3 more secondary outcomes
Study Arms (2)
ramucirumab (IMC-1121B) + docetaxel
EXPERIMENTALplacebo + docetaxel
PLACEBO COMPARATORInterventions
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 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
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.
Eligibility Criteria
You may qualify if:
- 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-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
- Participant has measurable and/or non-measurable disease
- 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)
- Participant has not received prior chemotherapy for metastatic or locally-recurrent and inoperable breast cancer
- Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization
- Participant completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization
- Participant completed all prior radiotherapy with curative intent ≥ 3 weeks prior to randomization
- Participant may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting ≥ 2 weeks prior to randomization
- Participant's left ventricular ejection fraction is within normal institutional ranges
- Participant has resolution to grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade ≤ 2
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Participant is amenable to compliance with protocol schedules and testing
- Participant has adequate hematological functions \[absolute neutrophil count (ANC) ≥ 1500 cells/microliter (mcL), hemoglobin ≥ 9 grams/deciliter (g/dL), and platelets ≥ 100,000 cells/mcL and ≤ 850,000 cells/mcL\]
- +6 more criteria
You may not qualify if:
- 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
- Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80
- Participant has a known sensitivity to agents of similar biologic composition as ramucirumab or other agents that specifically target vascular endothelial growth factor (VEGF)
- Participant has a history of chronic diarrheal disease within 6 months prior to randomization
- 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
- Participant has participated in clinical trials of experimental agents within 4 weeks prior to randomization
- Participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
- Participant has active, high risk bleeding (such as, via gastric ulcers or gastric varices) within 14 days prior to randomization
- Participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
- Participant has uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator
- Participant has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease
- Participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
- Participant has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
- Participant is pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (232)
ImClone Investigational Site
Birmingham, Alabama, 35202, United States
ImClone Investigational Site
Mobile, Alabama, 36608, United States
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Chandler, Arizona, 85224, United States
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Gilbert, Arizona, 85297, United States
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Mesa, Arizona, 85206, United States
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Alhambra, California, 91801, United States
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Bakersfield, California, 93309, United States
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Chula Vista, California, 91911, United States
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La Mesa, California, 91942, United States
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Los Angeles, California, 90095, United States
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Oceanside, California, 92056, United States
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Pasadena, California, 01107, United States
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Pasadena, California, 91105, United States
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San Diego, California, 92123, United States
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Santa Barbara, California, 93105, United States
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Santa Maria, California, 93454, United States
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Santa Monica, California, 90404, United States
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Solvang, California, 93463, United States
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Valencia, California, 91355, United States
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Aurora, Colorado, 80045, United States
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Fort Lauderdale, Florida, 33308, United States
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Gainesville, Florida, 32605, United States
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New Port Richey, Florida, 34655, United States
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Atlanta, Georgia, 30341, United States
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Atlanta, Georgia, 30342, United States
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Macon, Georgia, 31217, United States
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Marietta, Georgia, 30060, United States
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Alton, Illinois, 62002, United States
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Chicago, Illinois, 60076, United States
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Chicago, Illinois, 60611, United States
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Skokie, Illinois, 60076, United States
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Elkhart, Indiana, 46514, United States
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Mishawaka, Indiana, 46545, United States
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South Bend, Indiana, 46601, United States
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Westville, Indiana, 46891, United States
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Lexington, Kentucky, 40604, United States
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Lansing, Michigan, 48912, United States
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Saint Joseph, Michigan, 49085, United States
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Minneapolis, Minnesota, 55415, United States
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Southaven, Mississippi, 38671, United States
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St Louis, Missouri, 63136, United States
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Grand Island, Nebraska, 68803, United States
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Kearney, Nebraska, 68845, United States
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Henderson, Nevada, 89052, United States
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New York, New York, 10011, United States
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Charlotte, North Carolina, 15830, United States
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Charlotte, North Carolina, 28203, United States
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Charlotte, North Carolina, 28210, United States
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Charlotte, North Carolina, 28211, United States
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Charlotte, North Carolina, 28262, United States
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Charlotte, North Carolina, 28294, United States
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Bismarck, North Dakota, 58501, United States
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Oklahoma City, Oklahoma, 73120, United States
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Portland, Oregon, 97239, United States
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West Reading, Pennsylvania, 19611, United States
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Bartlett, Tennessee, 38133, United States
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Germantown, Tennessee, 38138, United States
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Memphis, Tennessee, 38104, United States
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Memphis, Tennessee, 38119, United States
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Memphis, Tennessee, 38120, United States
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Niles, Tennessee, 49120, United States
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Oxford, Tennessee, 38655, United States
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Lubbock, Texas, 79410, United States
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Temple, Texas, 76508, United States
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Salt Lake City, Utah, 84106, United States
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Fitzroy, Victoria, 3065, Australia
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Frankston, Victoria, 3199, Australia
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Bankstown, NSW2200, Australia
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Bedford Park, SA 5042, Australia
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Box Hill, V1C 3128, Australia
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Darlinghurst, NSW 2010, Australia
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East Bentleigh, VIC 3165, Australia
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East Melbourne, 3002, Australia
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Herston, QLD 4029, Australia
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Hobart, 7000, Australia
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Milton, QLD 4064, Australia
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Nambour, QLD 4560, Australia
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New Lambton Heights, NSW 2305, Australia
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Perth, WA 6001, Australia
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Ringwood East, 3135, Australia
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Subiaco, 6008, Australia
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Sydney, NSW 2010, Australia
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Tweed Heads, NSW 2305, Australia
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Wendouree, VIC 3355, Australia
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Brasschaat, 2930, Belgium
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Charleroi, 6000, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Yvoir, 5530, Belgium
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Ijuí, 98700-000, Brazil
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Porto Alegre, 90035-001, Brazil
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Porto Alegre, 90430-090, Brazil
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Porto Alegre, 906-000, Brazil
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Rio de Janeiro, 21941-913, Brazil
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Santo André, 09060-650, Brazil
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São Paulo, 01318-000, Brazil
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São Paulo, 05651-901, Brazil
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São Paulo, 08270-070, Brazil
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São Paulo, 1246-000, Brazil
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Calgary, Alberta, T2N4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Weston, Ontario, M9N 1N8, Canada
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Greenfield Park, Quebec, Canada
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Québec, G1S 4L8, Canada
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Osijek, 3100, Croatia
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Prague, Motol, 150 06, Czechia
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Brno, 62500, Czechia
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Kutná Hora, 28401, Czechia
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Pardubice, 532 03, Czechia
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Prague, 14059, Czechia
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Prague, 180 80, Czechia
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Videnska, 14059, Czechia
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Alexandria, 21526, Egypt
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Cairo, 11796, Egypt
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Cairo, 16114, Egypt
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Chemnitz, 9116, Germany
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Hamburg, 20246, Germany
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Hamburg, 22081, Germany
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Kiel, 24105, Germany
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Lübeck, 23538, Germany
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Munich, 80637, Germany
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München, 81675, Germany
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Oldenburg, 26133, Germany
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Saarbrücken, 66113, Germany
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Trier, 54290, Germany
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Tübingen, 72076, Germany
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Cork, Ireland
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Dublin, 7, Ireland
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Dublin, Ireland
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Erlangen, Ireland
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Limerick, Ireland
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Beersheva, 84101, Israel
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Jerusalem, 91129, Israel
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Petah Tikva, 49100, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 64239, Israel
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Beirut, Lebanon
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Bsalîm, Lebanon
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Metn, Lebanon
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Sidon, Lebanon
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Zghartā, Lebanon
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Auckland, 1023, New Zealand
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Auckland, New Zealand
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Palmerston North, 4414, New Zealand
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Arequipa, 054, Peru
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Lima, Lima1, Peru
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Lima, Lima27, Peru
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Lima, Lima34, Peru
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Lima, Lima41, Peru
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Lima, Lime27, Peru
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Bytom, 41-902, Poland
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Olsztyn, 10-228, Poland
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Olsztyn, 10-513, Poland
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Engel's, 413115, Russia
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Kazan', 420029, Russia
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Kursk, 305035, Russia
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Leningrad Region, Russia
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Lipetsk, 398005, Russia
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Magnitogorsk, 455001, Russia
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Moscow, 111033, Russia
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Moscow, 115478, Russia
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Moscow, 143423, Russia
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Novosibirsk, 630090, Russia
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Omsk, 644013, Russia
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Orenburg, 460021, Russia
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Perm, 614066, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Samara, 443031, Russia
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Saratov, 410004, Russia
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Tambov, 392013, Russia
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Ufa, 450054, Russia
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Kamenitz, 21204, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Bratislava, 81250, Slovakia
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Trnava, 91775, Slovakia
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Žilina, Slovakia
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Parktown, Johannesburg, 2193, South Africa
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Bloemfontein, 9301, South Africa
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Durban, 4001, South Africa
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Durban, 4091, South Africa
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eManzimtoti, 4126, South Africa
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Lynnwood, 0081, South Africa
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Port Elizabeth, 6045, South Africa
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Pretoria, 0001, South Africa
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Pretoria, 0081, South Africa
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Pretoria, 0181, South Africa
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Sandton, 2199, South Africa
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Incheon, 400-711, South Korea
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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A Coruña, 15009, Spain
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Alicante, 03010, Spain
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Badalona, 08916, Spain
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Barbastro, 22300, Spain
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Barcelona, 08003, Spain
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Barcelona, 08036, Spain
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Donostia / San Sebastian, 20014, Spain
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Girona, 17007, Spain
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Jaén, 23007, Spain
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La Laguna - Tenerife, 38205, Spain
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Lleida, 25198, Spain
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Madrid, 28007, Spain
ImClone Investigational Site
Madrid, 28033, Spain
ImClone Investigational Site
Madrid, 28034, Spain
ImClone Investigational Site
Madrid, 28040, Spain
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Madrid, 28222, Spain
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Málaga, 29010, Spain
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Palma de Mallorca, 07010, Spain
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Salamanca, 37007, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Toledo, 45004, Spain
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Valencia, 46009, Spain
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Valencia, Spain
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Zaragoza, 50009, Spain
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Changhua, M20 4BX, Taiwan
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Taipei, Taiwan
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Taoyuan, 33305, Taiwan
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Bournemouth, BH7 7DW, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Huddersfield, HD3 3EA, United Kingdom
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Hull, HU16 5JQ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
Related Publications (3)
Arnold D, Fuchs CS, Tabernero J, Ohtsu A, Zhu AX, Garon EB, Mackey JR, Paz-Ares L, Baron AD, Okusaka T, Yoshino T, Yoon HH, Das M, Ferry D, Zhang Y, Lin Y, Binder P, Sashegyi A, Chau I. Meta-analysis of individual patient safety data from six randomized, placebo-controlled trials with the antiangiogenic VEGFR2-binding monoclonal antibody ramucirumab. Ann Oncol. 2017 Dec 1;28(12):2932-2942. doi: 10.1093/annonc/mdx514.
PMID: 28950290DERIVEDSpera G, Fresco R, Fung H, Dyck JRB, Pituskin E, Paterson I, Mackey JR. Beta blockers and improved progression-free survival in patients with advanced HER2 negative breast cancer: a retrospective analysis of the ROSE/TRIO-012 study. Ann Oncol. 2017 Aug 1;28(8):1836-1841. doi: 10.1093/annonc/mdx264.
PMID: 28520849DERIVEDMackey JR, Ramos-Vazquez M, Lipatov O, McCarthy N, Krasnozhon D, Semiglazov V, Manikhas A, Gelmon KA, Konecny GE, Webster M, Hegg R, Verma S, Gorbunova V, Abi Gerges D, Thireau F, Fung H, Simms L, Buyse M, Ibrahim A, Martin M. Primary results of ROSE/TRIO-12, a randomized placebo-controlled phase III trial evaluating the addition of ramucirumab to first-line docetaxel chemotherapy in metastatic breast cancer. J Clin Oncol. 2015 Jan 10;33(2):141-8. doi: 10.1200/JCO.2014.57.1513. Epub 2014 Sep 2.
PMID: 25185099DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
One participant assigned to placebo + docetaxel (doc) treatment and was given ramucirumab (ram) in Cycle 1. Considered ram + doc treatment arm for safety population, for ITT population the participant was analyzed according to assigned treatment.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2008
First Posted
June 23, 2008
Study Start
August 6, 2008
Primary Completion
March 31, 2013
Study Completion
November 19, 2020
Last Updated
December 6, 2021
Results First Posted
June 17, 2014
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and european union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.