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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00703326




Registration number
NCT00703326
Ethics application status
Date submitted
20/06/2008
Date registered
23/06/2008
Date last updated
7/01/2020

Titles & IDs
Public title
Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer
Scientific title
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
Secondary ID [1] 0 0
2008-001727-65
Secondary ID [2] 0 0
13892
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ramucirumab (IMC-1121B)
Treatment: Drugs - docetaxel
Other interventions - Placebo

Experimental: ramucirumab (IMC-1121B) + docetaxel -

Placebo Comparator: placebo + docetaxel -


Other interventions: ramucirumab (IMC-1121B)
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.

Treatment: Drugs: docetaxel
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.

Other interventions: Placebo
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.

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 48 months)
Secondary outcome [1] 0 0
Overall Survival (OS) - OS was defined as the duration from randomization to death from any cause. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive.
Timepoint [1] 0 0
Randomization to death or until data cutoff of 31-Mar-2013 (up to 49 months)
Secondary outcome [2] 0 0
Time to Progression (TTP) - TTP was defined as the time from the date of randomization to the first documented date of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who did not progress were censored at the last radiographic tumor assessment. If no post-baseline assessment was available censoring occurred at the date of randomization. If PD occurred after 2 or more missing radiographic visits, censoring occurred at the 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.
Timepoint [2] 0 0
Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)
Secondary outcome [3] 0 0
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate) - Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), based on the achievement of both measurement and confirmation criteria; by Investigator assessment. CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions.
Timepoint [3] 0 0
Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)
Secondary outcome [4] 0 0
Duration of Response - Duration of complete response (CR) or partial response (PR) measured from time criteria were first met for CR or PR until first date of progressive disease (PD) or death from any cause defined using Response Evaluation Criteria in Solid Tumor (RECIST 1.0); by Investigator assessment. CR defined as disappearance of all target and non-target lesions. PR defined as =30% decrease in sum of longest diameter (LD) of target lesions and no progression in non-target lesions. PD defined as =20% increase in LD sum of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of =1 new lesion(s). Participants who did not relapse or die censored at day of last radiographic tumor assessment. If death or PD was after =2 missing radiographic visits, censoring was at date of last radiographic visit prior to missed visits. Symptomatic/clinical disease progression without documented radiologic progression did not constitute progression.
Timepoint [4] 0 0
Date of first CR or PR to PD or death or until data cutoff date of 31-Mar-2013 (up to 35 months)
Secondary outcome [5] 0 0
Total Functional Assessment of Cancer Therapy-Breast (FACT-B): Change From Baseline to End of Therapy - FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), and additional concerns of breast cancer subscale (BCS) each with 6 or more items developed to measure problems specific to breast cancer symptoms plus additional items related to global QoL. Participants respond to each of the 36 questions on a 5-point scale from 0 (not at all) to 4 (very much) with a total scores range of 0-144. Higher scores indicate fewer symptoms and better HR-QoL.
Timepoint [5] 0 0
Baseline, End of Therapy or until data cutoff of 31-Mar-2013 (up to 42 months)
Secondary outcome [6] 0 0
Number of Participants With Adverse Events - Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and other NSAEs is located in the Reported Adverse Event module.
Timepoint [6] 0 0
First dose to study completion (up to 49 months) plus 30-day safety follow-up

Eligibility
Key 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-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]

- Participant has adequate hepatic function [bilirubin within normal limits (WNL),
aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 times the upper
limit of normal (ULN), or = 5.0 times the ULN if the transaminase elevation is due to
liver metastases, and alkaline phosphatase = 5.0 times the ULN]

- Participant has serum creatinine = 1.5 x ULN. If serum creatinine > 1.5 x ULN the
calculated creatinine clearance should be > 40 milliliters/minute (mL/min)

- Participant's urinary protein is = 1+ on dipstick or routine urinalysis (UA); if urine
protein = 2+, a 24-hour urine collection must demonstrate < 1000 milligrams (mg) of
protein in 24 hours to allow participation in the study

- Participant must have adequate coagulation function as defined by international
normalized ratio (INR) = 1.5 and a partial thromboplastin time (PTT) = 1.5 X ULN if
not receiving anticoagulation therapy. Participants on full-dose anticoagulation must
be on a stable dose of oral anticoagulant or low molecular weight heparin and if on
warfarin must have a INR between 2 and 3 and have no active bleeding (defined as
within 14 days of randomization) or pathological condition that carries a high risk of
bleeding (such as, tumor involving major vessels or known varices)

- Women of childbearing potential must implement adequate contraception in the opinion
of the investigator

- Participant has not received prior biologic therapy for metastatic or locally
recurrent and inoperable breast cancer
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
ImClone Investigational Site - Fitzroy
Recruitment hospital [2] 0 0
ImClone Investigational Site - Frankston
Recruitment hospital [3] 0 0
ImClone Investigational Site - Bankstown
Recruitment hospital [4] 0 0
ImClone Investigational Site - Bedford Park
Recruitment hospital [5] 0 0
ImClone Investigational Site - Box Hill
Recruitment hospital [6] 0 0
ImClone Investigational Site - Darlinghurst
Recruitment hospital [7] 0 0
ImClone Investigational Site - East Bentleigh
Recruitment hospital [8] 0 0
ImClone Investigational Site - East Melbourne
Recruitment hospital [9] 0 0
ImClone Investigational Site - Herston
Recruitment hospital [10] 0 0
ImClone Investigational Site - Hobart
Recruitment hospital [11] 0 0
ImClone Investigational Site - Milton
Recruitment hospital [12] 0 0
ImClone Investigational Site - Nambour
Recruitment hospital [13] 0 0
ImClone Investigational Site - New Lambton Heights
Recruitment hospital [14] 0 0
ImClone Investigational Site - Perth
Recruitment hospital [15] 0 0
ImClone Investigational Site - Ringwood East
Recruitment hospital [16] 0 0
ImClone Investigational Site - Subiaco
Recruitment hospital [17] 0 0
ImClone Investigational Site - Sydney
Recruitment hospital [18] 0 0
ImClone Investigational Site - Tweed Heads
Recruitment hospital [19] 0 0
ImClone Investigational Site - Wendouree
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
NSW2200 - Bankstown
Recruitment postcode(s) [4] 0 0
SA 5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
V1C 3128 - Box Hill
Recruitment postcode(s) [6] 0 0
NSW 2010 - Darlinghurst
Recruitment postcode(s) [7] 0 0
VIC 3165 - East Bentleigh
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
QLD 4064 - Milton
Recruitment postcode(s) [12] 0 0
QLD 4560 - Nambour
Recruitment postcode(s) [13] 0 0
NSW 2305 - New Lambton Heights
Recruitment postcode(s) [14] 0 0
WA 6001 - Perth
Recruitment postcode(s) [15] 0 0
3135 - Ringwood East
Recruitment postcode(s) [16] 0 0
6008 - Subiaco
Recruitment postcode(s) [17] 0 0
NSW 2010 - Sydney
Recruitment postcode(s) [18] 0 0
NSW 2305 - Tweed Heads
Recruitment postcode(s) [19] 0 0
VIC 3355 - Wendouree
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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United States of America
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Colorado
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Georgia
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Illinois
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Indiana
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United States of America
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Kentucky
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New York
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Belgium
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Brasschaat
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Liege
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Belgium
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Namur
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Belgium
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Yvoir
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Ijui
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Rio de Janeiro
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San Paulo
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Santo Andre
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Sao Paulo
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Alberta
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British Columbia
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Ontario
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Quebec
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Osijek
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Motol
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Brno
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Kutna Hora
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Pardubice
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Prague
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Videnska
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Alexandria
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Kiel
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Lubeck
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Munchen
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Munich
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Germany
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Oldenburg
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Saarbrucken
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Germany
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Trier
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Tubingen
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Cork
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Dublin
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Erlangen
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Ireland
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Limerick
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Israel
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Beersheva
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Israel
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Jerusalem
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Israel
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Petach-Tikva
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Israel
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Rehovot
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Israel
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Tel Aviv
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Lebanon
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Beirut
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Lebanon
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Bsalim
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Lebanon
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Metn
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Lebanon
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Saïda
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Lebanon
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Zgharta
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New Zealand
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Auckland
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New Zealand
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Palmerston North
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Peru
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Arequipa
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Peru
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Lima
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Poland
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Bytom
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Poland
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Olsztyn
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Russian Federation
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Engels
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Russian Federation
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Russian Federation
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Kursk
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Russian Federation
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Leningrad Region
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Russian Federation
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Lipetsk
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Russian Federation
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Magnitogorsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Orenburg
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Russian Federation
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Perm
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Russian Federation
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Samara
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Russian Federation
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Tambov
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Russian Federation
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Ufa
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Serbia
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Kragujevac
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Serbia
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Nis
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Serbia
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Sremska Kamenica
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Slovakia
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Bratislava
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Slovakia
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Trnava
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Slovakia
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Zilina
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South Africa
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Johannesburg
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South Africa
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Amanzimtoti
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South Africa
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Bloemfontein
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South Africa
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Durban
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South Africa
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Lynnwood
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South Africa
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Port Elizabeth
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South Africa
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Pretoria
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South Africa
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Sandton
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Spain
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Alicante
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Spain
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Badalona
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Spain
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Barbastro
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Spain
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Barcelona
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Spain
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Girona
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Spain
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Jaen
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Spain
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La Caruna
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Spain
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La Coruna
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Spain
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La Laguna - Tenerife
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Palma de Mallorca
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Spain
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Salamanca
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Spain
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San Sebastian
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Toledo
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Spain
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Valencia
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Spain
State/province [133] 0 0
Zaragoza
Country [134] 0 0
Taiwan
State/province [134] 0 0
Changhua
Country [135] 0 0
Taiwan
State/province [135] 0 0
Taipei
Country [136] 0 0
Taiwan
State/province [136] 0 0
Taoyuan County
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Bournemouth
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Edinburgh
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Huddersfield
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Hull
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Manchester
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00703326
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications