Clinical trial NCT00703326: Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Metastatic breast cancer
HER2 negative breast cancer
locally recurrent breast cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-06-23
Enrollment: 1144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Female participants at least 18 years of age with histologically or cytologically confirmed, human epidermal growth factor receptor 2 (HER2) negative breast adenocarcinoma that is metastatic or locally-recurrent and inoperable with curative intent will be randomized. Participants may not have received chemotherapy for metastatic or locally-recurrent, inoperable breast cancer.

It is anticipated that 1113 participants will be randomized with 371 participants in the docetaxel plus placebo arm and 742 participants in the docetaxel plus ramucirumab (IMC-1121B) arm. There will be approximately 250 centers in North and South America, Europe, Asia, Middle East, Africa, Australia, and New Zealand.

On Day 1 of each 21-day cycle, participants will receive docetaxel 75 mg/m² as a one-hour I.V. infusion followed by either ramucirumab (IMC-1121B) 10 mg/kg or placebo 10 mg/kg as a one-hour I.V. infusion. Each cycle is repeated every 21 days.

Treatment will continue until there is evidence of progressive disease, unacceptable toxicity, or other withdrawal criteria are met. Participants who discontinue study treatment with either ramucirumab (IMC-1121B) or placebo may continue to receive docetaxel.

Eligibility criteria: 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

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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 56 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization to death or until data cutoff of 29-May-2015 (up to 82 months)
measure: Time to Progression (TTP)
timeFrame: Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months)
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
timeFrame: Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months)
measure: Duration of Response
timeFrame: Date of first CR or PR to PD or death or until data cutoff date of 31-Mar-2013 (up to 56 months)
measure: Total Functional Assessment of Cancer Therapy-Breast (FACT-B): Change From Baseline to End of Therapy
timeFrame: Baseline, End of Therapy or until data cutoff of 31-Mar-2013 (up to 56 months)
measure: Number of Participants With Adverse Events
timeFrame: First dose to study completion (up to 12.3 years)
measure: Immunogenicity: Percentage of Participants With Treatment Emergent Anti-Ramucirumab Antibodies Until Primary Data Cutoff of 31-Mar-2013
timeFrame: Baseline, prior to cycle 3 infusion, prior to cycle 5 infusion, onset of infusion reaction, resolution of reaction and 30 days following the event up to 56 months
measure: Immunogenicity: Percentage of Participants Available After 31-Mar-2013 With Treatment Emergent Anti-Ramucirumab Antibodies Until Data Cutoff From 01-Apr-2013 to 08-Sep-2016
timeFrame: Follow-up from 01-Apr-2013 to 08-Sep-2016 (Up to 56 -97 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: ImClone Investigational Site
state: Alabama
city: Mobile
country: United States
facility: ImClone Investigational Site
state: Alabama
city: Chandler
country: United States
facility: ImClone Investigational Site
state: Arizona
city: Gilbert
country: United States
facility: ImClone Investigational Site
state: Arizona
city: Mesa
country: United States
facility: ImClone Investigational Site
state: Arizona
city: Alhambra
country: United States
facility: ImClone Investigational Site
state: California
city: Bakersfield
country: United States
facility: ImClone Investigational Site
state: California
city: Chula Vista
country: United States
facility: ImClone Investigational Site
state: California
city: La Mesa
country: United States
facility: ImClone Investigational Site
state: California
city: Los Angeles
country: United States
facility: ImClone Investigational Site
state: California
city: Oceanside
country: United States
facility: ImClone Investigational Site
state: California
city: Pasadena
country: United States
facility: ImClone Investigational Site
state: California
city: Pasadena
country: United States
facility: ImClone Investigational Site
state: California
city: San Diego
country: United States
facility: ImClone Investigational Site
state: California
city: Santa Barbara
country: United States
facility: ImClone Investigational Site
state: California
city: Santa Maria
country: United States
facility: ImClone Investigational Site
state: California
city: Santa Monica
country: United States
facility: ImClone Investigational Site
state: California
city: Solvang
country: United States
facility: ImClone Investigational Site
state: California
city: Valencia
country: United States
facility: ImClone Investigational Site
state: California
city: Aurora
country: United States
facility: ImClone Investigational Site
state: Colorado
city: Fort Lauderdale
country: United States
facility: ImClone Investigational Site
state: Florida
city: Gainesville
country: United States
facility: ImClone Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: ImClone Investigational Site
state: Florida
city: Atlanta
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Macon
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Marietta
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Alton
country: United States
facility: ImClone Investigational Site
state: Illinois
city: Chicago
country: United States
facility: ImClone Investigational Site
state: Illinois
city: Chicago
country: United States
facility: ImClone Investigational Site
state: Illinois
city: Skokie
country: United States
facility: ImClone Investigational Site
state: Illinois
city: Elkhart
country: United States
facility: ImClone Investigational Site
state: Indiana
city: Mishawaka
country: United States
facility: ImClone Investigational Site
state: Indiana
city: South Bend
country: United States
facility: ImClone Investigational Site
state: Indiana
city: Westville
country: United States
facility: ImClone Investigational Site
state: Indiana
city: Lexington
country: United States
facility: ImClone Investigational Site
state: Kentucky
city: Lansing
country: United States
facility: ImClone Investigational Site
state: Michigan
city: Saint Joseph
country: United States
facility: ImClone Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: ImClone Investigational Site
state: Minnesota
city: Southaven
country: United States
facility: ImClone Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: ImClone Investigational Site
state: Missouri
city: Grand Island
country: United States
facility: ImClone Investigational Site
state: Nebraska
city: Kearney
country: United States
facility: ImClone Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: ImClone Investigational Site
state: Nevada
city: New York
country: United States
facility: ImClone Investigational Site
state: New York
city: Charlotte
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: ImClone Investigational Site
state: North Dakota
city: Oklahoma City
country: United States
facility: ImClone Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: ImClone Investigational Site
state: Oregon
city: West Reading
country: United States
facility: ImClone Investigational Site
state: Pennsylvania
city: Bartlett
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Niles
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Oxford
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Lubbock
country: United States
facility: ImClone Investigational Site
state: Texas
city: Temple
country: United States
facility: ImClone Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: ImClone Investigational Site
state: Utah
city: Fitzroy
country: Australia
facility: ImClone Investigational Site
state: Victoria
city: Frankston
country: Australia
facility: ImClone Investigational Site
state: Victoria
city: Bankstown
country: Australia
facility: ImClone Investigational Site
city: Bedford Park
country: Australia
facility: ImClone Investigational Site
city: Box Hill
country: Australia
facility: ImClone Investigational Site
city: Darlinghurst
country: Australia
facility: ImClone Investigational Site
city: East Bentleigh
country: Australia
facility: ImClone Investigational Site
city: East Melbourne
country: Australia
facility: ImClone Investigational Site
city: Herston
country: Australia
facility: ImClone Investigational Site
city: Hobart
country: Australia
facility: ImClone Investigational Site
city: Milton
country: Australia
facility: ImClone Investigational Site
city: Nambour
country: Australia
facility: ImClone Investigational Site
city: New Lambton Heights
country: Australia
facility: ImClone Investigational Site
city: Perth
country: Australia
facility: ImClone Investigational Site
city: Ringwood East
country: Australia
facility: ImClone Investigational Site
city: Subiaco
country: Australia
facility: ImClone Investigational Site
city: Sydney
country: Australia
facility: ImClone Investigational Site
city: Tweed Heads
country: Australia
facility: ImClone Investigational Site
city: Wendouree
country: Australia
facility: ImClone Investigational Site
city: Brasschaat
country: Belgium
facility: ImClone Investigational Site
city: Charleroi
country: Belgium
facility: ImClone Investigational Site
city: Edegem
country: Belgium
facility: ImClone Investigational Site
city: Gent
country: Belgium
facility: ImClone Investigational Site
city: Kortrijk
country: Belgium
facility: ImClone Investigational Site
city: Liege
country: Belgium
facility: ImClone Investigational Site
city: Namur
country: Belgium
facility: ImClone Investigational Site
city: Yvoir
country: Belgium
facility: ImClone Investigational Site
city: Ijui
country: Brazil
facility: ImClone Investigational Site
city: Porto Alegre
country: Brazil
facility: ImClone Investigational Site
city: Porto Alegre
country: Brazil
facility: ImClone Investigational Site
city: Porto Alegre
country: Brazil
facility: ImClone Investigational Site
city: Rio de Janeiro
country: Brazil
facility: ImClone Investigational Site
city: San Paulo
country: Brazil
facility: ImClone Investigational Site
city: San Paulo
country: Brazil
facility: ImClone Investigational Site
city: Santo Andre
country: Brazil
facility: ImClone Investigational Site
city: Sao Paulo
country: Brazil
facility: ImClone Investigational Site
city: Sao Paulo
country: Brazil
facility: ImClone Investigational Site
city: Sao Paulo
country: Brazil
facility: ImClone Investigational Site
city: Calgary
country: Canada
facility: ImClone Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: ImClone Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: ImClone Investigational Site
state: British Columbia
city: Toronto
country: Canada
facility: ImClone Investigational Site
state: Ontario
city: Weston
country: Canada
facility: ImClone Investigational Site
state: Ontario
city: Greenfield Park
country: Canada
facility: ImClone Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: ImClone Investigational Site
city: Osijek
country: Croatia
facility: ImClone Investigational Site
city: Praha
country: Czechia
facility: ImClone Investigational Site
state: Motol
city: Brno
country: Czechia
facility: ImClone Investigational Site
city: Kutna Hora
country: Czechia
facility: ImClone Investigational Site
city: Pardubice
country: Czechia
facility: ImClone Investigational Site
city: Prague
country: Czechia
facility: ImClone Investigational Site
city: Prague
country: Czechia
facility: ImClone Investigational Site
city: Videnska
country: Czechia
facility: ImClone Investigational Site
city: Alexandria
country: Egypt
facility: ImClone Investigational Site
city: Cairo
country: Egypt
facility: ImClone Investigational Site
city: Cairo
country: Egypt
facility: ImClone Investigational Site
city: Chemnitz
country: Germany
facility: ImClone Investigational Site
city: Hamburg
country: Germany
facility: ImClone Investigational Site
city: Hamburg
country: Germany
facility: ImClone Investigational Site
city: Kiel
country: Germany
facility: ImClone Investigational Site
city: Lubeck
country: Germany
facility: ImClone Investigational Site
city: Munchen
country: Germany
facility: ImClone Investigational Site
city: Munich
country: Germany
facility: ImClone Investigational Site
city: Oldenburg
country: Germany
facility: ImClone Investigational Site
city: Saarbrucken
country: Germany
facility: ImClone Investigational Site
city: Trier
country: Germany
facility: ImClone Investigational Site
city: Tubingen
country: Germany
facility: ImClone Investigational Site
city: Cork
country: Ireland
facility: ImClone Investigational Site
city: Dublin
country: Ireland
facility: ImClone Investigational Site
city: Dublin
country: Ireland
facility: ImClone Investigational Site
city: Erlangen
country: Ireland
facility: ImClone Investigational Site
city: Limerick
country: Ireland
facility: ImClone Investigational Site
city: Beersheva
country: Israel
facility: ImClone Investigational Site
city: Jerusalem
country: Israel
facility: ImClone Investigational Site
city: Petach-Tikva
country: Israel
facility: ImClone Investigational Site
city: Rehovot
country: Israel
facility: ImClone Investigational Site
city: Tel Aviv
country: Israel
facility: ImClone Investigational Site
city: Incheon
country: Korea, Republic of
facility: ImClone Investigational Site
city: Seoul
country: Korea, Republic of
facility: ImClone Investigational Site
city: Seoul
country: Korea, Republic of
facility: ImClone Investigational Site
city: Seoul
country: Korea, Republic of
facility: ImClone Investigational Site
city: Beirut
country: Lebanon
facility: ImClone Investigational Site
city: Bsalim
country: Lebanon
facility: ImClone Investigational Site
city: Metn
country: Lebanon
facility: ImClone Investigational Site
city: Saïda
country: Lebanon
facility: ImClone Investigational Site
city: Zgharta
country: Lebanon
facility: ImClone Investigational Site
city: Auckland
country: New Zealand
facility: ImClone Investigational Site
city: Auckland
country: New Zealand
facility: ImClone Investigational Site
city: Palmerston North
country: New Zealand
facility: ImClone Investigational Site
city: Arequipa
country: Peru
facility: ImClone Investigational Site
city: Lima
country: Peru
facility: ImClone Investigational Site
city: Lima
country: Peru
facility: ImClone Investigational Site
city: Lima
country: Peru
facility: ImClone Investigational Site
city: Lima
country: Peru
facility: ImClone Investigational Site
city: Lima
country: Peru
facility: ImClone Investigational Site
city: Bytom
country: Poland
facility: ImClone Investigational Site
city: Olsztyn
country: Poland
facility: ImClone Investigational Site
city: Olsztyn
country: Poland
facility: ImClone Investigational Site
city: Engels
country: Russian Federation
facility: ImClone Investigational Site
city: Kazan
country: Russian Federation
facility: ImClone Investigational Site
city: Kursk
country: Russian Federation
facility: ImClone Investigational Site
city: Leningrad Region
country: Russian Federation
facility: ImClone Investigational Site
city: Lipetsk
country: Russian Federation
facility: ImClone Investigational Site
city: Magnitogorsk
country: Russian Federation
facility: ImClone Investigational Site
city: Moscow
country: Russian Federation
facility: ImClone Investigational Site
city: Moscow
country: Russian Federation
facility: ImClone Investigational Site
city: Moscow
country: Russian Federation
facility: ImClone Investigational Site
city: Novosibirsk
country: Russian Federation
facility: ImClone Investigational Site
city: Omsk
country: Russian Federation
facility: ImClone Investigational Site
city: Orenburg
country: Russian Federation
facility: ImClone Investigational Site
city: Perm
country: Russian Federation
facility: ImClone Investigational Site
city: Samara
country: Russian Federation
facility: ImClone Investigational Site
city: Saratov
country: Russian Federation
facility: ImClone Investigational Site
city: St. Petersburg
country: Russian Federation
facility: ImClone Investigational Site
city: St. Petersburg
country: Russian Federation
facility: ImClone Investigational Site
city: Tambov
country: Russian Federation
facility: ImClone Investigational Site
city: Ufa
country: Russian Federation
facility: ImClone Investigational Site
city: Kragujevac
country: Serbia
facility: ImClone Investigational Site
city: Nis
country: Serbia
facility: ImClone Investigational Site
city: Sremska Kamenica
country: Serbia
facility: ImClone Investigational Site
city: Bratislava
country: Slovakia
facility: ImClone Investigational Site
city: Trnava
country: Slovakia
facility: ImClone Investigational Site
city: Zilina
country: Slovakia
facility: ImClone Investigational Site
city: Parktown
country: South Africa
facility: ImClone Investigational Site
state: Johannesburg
city: Amanzimtoti
country: South Africa
facility: ImClone Investigational Site
city: Bloemfontein
country: South Africa
facility: ImClone Investigational Site
city: Durban
country: South Africa
facility: ImClone Investigational Site
city: Durban
country: South Africa
facility: ImClone Investigational Site
city: Lynnwood
country: South Africa
facility: ImClone Investigational Site
city: Port Elizabeth
country: South Africa
facility: ImClone Investigational Site
city: Pretoria
country: South Africa
facility: ImClone Investigational Site
city: Pretoria
country: South Africa
facility: ImClone Investigational Site
city: Pretoria
country: South Africa
facility: ImClone Investigational Site
city: Sandton
country: South Africa
facility: ImClone Investigational Site
city: Alicante
country: Spain
facility: ImClone Investigational Site
city: Badalona
country: Spain
facility: ImClone Investigational Site
city: Barbastro
country: Spain
facility: ImClone Investigational Site
city: Barcelona
country: Spain
facility: ImClone Investigational Site
city: Barcelona
country: Spain
facility: ImClone Investigational Site
city: Girona
country: Spain
facility: ImClone Investigational Site
city: Jaen
country: Spain
facility: ImClone Investigational Site
city: La Coruna
country: Spain
facility: ImClone Investigational Site
city: La Laguna - Tenerife
country: Spain
facility: ImClone Investigational Site
city: Lleida
country: Spain
facility: ImClone Investigational Site
city: Madrid
country: Spain
facility: ImClone Investigational Site
city: Madrid
country: Spain
facility: ImClone Investigational Site
city: Madrid
country: Spain
facility: ImClone Investigational Site
city: Madrid
country: Spain
facility: ImClone Investigational Site
city: Madrid
country: Spain
facility: ImClone Investigational Site
city: Malaga
country: Spain
facility: ImClone Investigational Site
city: Palma de Mallorca
country: Spain
facility: ImClone Investigational Site
city: Salamanca
country: Spain
facility: ImClone Investigational Site
city: San Sebastian
country: Spain
facility: ImClone Investigational Site
city: Santander
country: Spain
facility: ImClone Investigational Site
city: Sevilla
country: Spain
facility: ImClone Investigational Site
city: Toledo
country: Spain
facility: ImClone Investigational Site
city: Valencia
country: Spain
facility: ImClone Investigational Site
city: Valencia
country: Spain
facility: ImClone Investigational Site
city: Zaragoza
country: Spain
facility: ImClone Investigational Site
city: Changhua
country: Taiwan
facility: ImClone Investigational Site
city: Taipei
country: Taiwan
facility: ImClone Investigational Site
city: Taoyuan County
country: Taiwan
facility: ImClone Investigational Site
city: Bournemouth
country: United Kingdom
facility: ImClone Investigational Site
city: Edinburgh
country: United Kingdom
facility: ImClone Investigational Site
city: Huddersfield
country: United Kingdom
facility: ImClone Investigational Site
city: Hull
country: United Kingdom
facility: ImClone Investigational Site
city: Manchester
country: United Kingdom
facility: ImClone Investigational Site
city: Nottingham
country: United Kingdom
facility: ImClone Investigational Site
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Spera 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.
citation: Mackey 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.