AzTrials
AzTrials

Breast CancerPhase 3NCT00703326

Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer

A Phase 3 study testing ramucirumab (IMC-1121B) and docetaxel in people with Breast Cancer, run by Eli Lilly and Company at 232 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
ramucirumab (IMC-1121B) and docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,144 participants
Where
232 sitesin 23 countries
Study dates
6 Aug 2008to 19 Nov 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

232 sites in 23 countries.

232 sites in 23 countries

United States65 sites

  • ImClone Investigational Site

    Alhambra, California, 91801

  • ImClone Investigational Site

    Alton, Illinois, 62002

  • ImClone Investigational Site

    Atlanta, Georgia, 30341

  • ImClone Investigational Site

    Atlanta, Georgia, 30342

  • ImClone Investigational Site

    Aurora, Colorado, 80045

  • ImClone Investigational Site

    Bakersfield, California, 93309

  • ImClone Investigational Site

    Bartlett, Tennessee, 38133

  • ImClone Investigational Site

    Birmingham, Alabama, 35202

  • ImClone Investigational Site

    Bismarck, North Dakota, 58501

  • ImClone Investigational Site

    Chandler, Arizona, 85224

  • ImClone Investigational Site

    Charlotte, North Carolina, 15830

  • ImClone Investigational Site

    Charlotte, North Carolina, 28203

  • ImClone Investigational Site

    Charlotte, North Carolina, 28210

  • ImClone Investigational Site

    Charlotte, North Carolina, 28211

  • ImClone Investigational Site

    Charlotte, North Carolina, 28262

  • ImClone Investigational Site

    Charlotte, North Carolina, 28294

  • ImClone Investigational Site

    Chicago, Illinois, 60076

  • ImClone Investigational Site

    Chicago, Illinois, 60611

  • ImClone Investigational Site

    Chula Vista, California, 91911

  • ImClone Investigational Site

    Elkhart, Indiana, 46514

  • ImClone Investigational Site

    Fort Lauderdale, Florida, 33308

  • ImClone Investigational Site

    Gainesville, Florida, 32605

  • ImClone Investigational Site

    Germantown, Tennessee, 38138

  • ImClone Investigational Site

    Gilbert, Arizona, 85297

  • ImClone Investigational Site

    Grand Island, Nebraska, 68803

  • ImClone Investigational Site

    Henderson, Nevada, 89052

  • ImClone Investigational Site

    Kearney, Nebraska, 68845

  • ImClone Investigational Site

    La Mesa, California, 91942

  • ImClone Investigational Site

    Lansing, Michigan, 48912

  • ImClone Investigational Site

    Lexington, Kentucky, 40604

  • ImClone Investigational Site

    Los Angeles, California, 90095

  • ImClone Investigational Site

    Lubbock, Texas, 79410

  • ImClone Investigational Site

    Macon, Georgia, 31217

  • ImClone Investigational Site

    Marietta, Georgia, 30060

  • ImClone Investigational Site

    Memphis, Tennessee, 38104

  • ImClone Investigational Site

    Memphis, Tennessee, 38119

  • ImClone Investigational Site

    Memphis, Tennessee, 38120

  • ImClone Investigational Site

    Mesa, Arizona, 85206

  • ImClone Investigational Site

    Minneapolis, Minnesota, 55415

  • ImClone Investigational Site

    Mishawaka, Indiana, 46545

  • ImClone Investigational Site

    Mobile, Alabama, 36608

  • ImClone Investigational Site

    New Port Richey, Florida, 34655

  • ImClone Investigational Site

    New York, New York, 10011

  • ImClone Investigational Site

    Niles, Tennessee, 49120

  • ImClone Investigational Site

    Oceanside, California, 92056

  • ImClone Investigational Site

    Oklahoma City, Oklahoma, 73120

  • ImClone Investigational Site

    Oxford, Tennessee, 38655

  • ImClone Investigational Site

    Pasadena, California, 01107

  • ImClone Investigational Site

    Pasadena, California, 91105

  • ImClone Investigational Site

    Portland, Oregon, 97239

  • ImClone Investigational Site

    Saint Joseph, Michigan, 49085

  • ImClone Investigational Site

    Salt Lake City, Utah, 84106

  • ImClone Investigational Site

    San Diego, California, 92123

  • ImClone Investigational Site

    Santa Barbara, California, 93105

  • ImClone Investigational Site

    Santa Maria, California, 93454

  • ImClone Investigational Site

    Santa Monica, California, 90404

  • ImClone Investigational Site

    Skokie, Illinois, 60076

  • ImClone Investigational Site

    Solvang, California, 93463

  • ImClone Investigational Site

    South Bend, Indiana, 46601

  • ImClone Investigational Site

    Southaven, Mississippi, 38671

  • ImClone Investigational Site

    St Louis, Missouri, 63136

  • ImClone Investigational Site

    Temple, Texas, 76508

  • ImClone Investigational Site

    Valencia, California, 91355

  • ImClone Investigational Site

    West Reading, Pennsylvania, 19611

  • ImClone Investigational Site

    Westville, Indiana, 46891

Other trials in United States

Spain25 sites

  • ImClone Investigational Site

    A Coruña, 15009

  • ImClone Investigational Site

    Alicante, 03010

  • ImClone Investigational Site

    Badalona, 08916

  • ImClone Investigational Site

    Barbastro, 22300

  • ImClone Investigational Site

    Barcelona, 08003

  • ImClone Investigational Site

    Barcelona, 08036

  • ImClone Investigational Site

    Donostia / San Sebastian, 20014

  • ImClone Investigational Site

    Girona, 17007

  • ImClone Investigational Site

    Jaén, 23007

  • ImClone Investigational Site

    La Laguna - Tenerife, 38205

  • ImClone Investigational Site

    Lleida, 25198

  • ImClone Investigational Site

    Madrid, 28007

  • ImClone Investigational Site

    Madrid, 28033

  • ImClone Investigational Site

    Madrid, 28034

  • ImClone Investigational Site

    Madrid, 28040

  • ImClone Investigational Site

    Madrid, 28222

  • ImClone Investigational Site

    Málaga, 29010

  • ImClone Investigational Site

    Palma de Mallorca, 07010

  • ImClone Investigational Site

    Salamanca, 37007

  • ImClone Investigational Site

    Santander, 39008

  • ImClone Investigational Site

    Seville, 41013

  • ImClone Investigational Site

    Toledo, 45004

  • ImClone Investigational Site

    Valencia, 46009

  • ImClone Investigational Site

    Valencia

  • ImClone Investigational Site

    Zaragoza, 50009

Other trials in Spain

Australia19 sites

  • ImClone Investigational Site

    Bankstown, NSW2200

  • ImClone Investigational Site

    Bedford Park, SA 5042

  • ImClone Investigational Site

    Box Hill, V1C 3128

  • ImClone Investigational Site

    Darlinghurst, NSW 2010

  • ImClone Investigational Site

    East Bentleigh, VIC 3165

  • ImClone Investigational Site

    East Melbourne, 3002

  • ImClone Investigational Site

    Fitzroy, Victoria, 3065

  • ImClone Investigational Site

    Frankston, Victoria, 3199

  • ImClone Investigational Site

    Herston, QLD 4029

  • ImClone Investigational Site

    Hobart, 7000

  • ImClone Investigational Site

    Milton, QLD 4064

  • ImClone Investigational Site

    Nambour, QLD 4560

  • ImClone Investigational Site

    New Lambton Heights, NSW 2305

  • ImClone Investigational Site

    Perth, WA 6001

  • ImClone Investigational Site

    Ringwood East, 3135

  • ImClone Investigational Site

    Subiaco, 6008

  • ImClone Investigational Site

    Sydney, NSW 2010

  • ImClone Investigational Site

    Tweed Heads, NSW 2305

  • ImClone Investigational Site

    Wendouree, VIC 3355

Other trials in Australia

Russia19 sites

  • ImClone Investigational Site

    Engel's, 413115

  • ImClone Investigational Site

    Kazan', 420029

  • ImClone Investigational Site

    Kursk, 305035

  • ImClone Investigational Site

    Leningrad Region

  • ImClone Investigational Site

    Lipetsk, 398005

  • ImClone Investigational Site

    Magnitogorsk, 455001

  • ImClone Investigational Site

    Moscow, 111033

  • ImClone Investigational Site

    Moscow, 115478

  • ImClone Investigational Site

    Moscow, 143423

  • ImClone Investigational Site

    Novosibirsk, 630090

  • ImClone Investigational Site

    Omsk, 644013

  • ImClone Investigational Site

    Orenburg, 460021

  • ImClone Investigational Site

    Perm, 614066

  • ImClone Investigational Site

    Saint Petersburg, 197022

  • ImClone Investigational Site

    Saint Petersburg, 197758

  • ImClone Investigational Site

    Samara, 443031

  • ImClone Investigational Site

    Saratov, 410004

  • ImClone Investigational Site

    Tambov, 392013

  • ImClone Investigational Site

    Ufa, 450054

Other trials in Russia

Germany11 sites

  • ImClone Investigational Site

    Chemnitz, 9116

  • ImClone Investigational Site

    Hamburg, 20246

  • ImClone Investigational Site

    Hamburg, 22081

  • ImClone Investigational Site

    Kiel, 24105

  • ImClone Investigational Site

    Lübeck, 23538

  • ImClone Investigational Site

    München, 81675

  • ImClone Investigational Site

    Munich, 80637

  • ImClone Investigational Site

    Oldenburg, 26133

  • ImClone Investigational Site

    Saarbrücken, 66113

  • ImClone Investigational Site

    Trier, 54290

  • ImClone Investigational Site

    Tübingen, 72076

Other trials in Germany

South Africa11 sites

  • ImClone Investigational Site

    Bloemfontein, 9301

  • ImClone Investigational Site

    Durban, 4001

  • ImClone Investigational Site

    Durban, 4091

  • ImClone Investigational Site

    eManzimtoti, 4126

  • ImClone Investigational Site

    Lynnwood, 0081

  • ImClone Investigational Site

    Parktown, Johannesburg, 2193

  • ImClone Investigational Site

    Port Elizabeth, 6045

  • ImClone Investigational Site

    Pretoria, 0001

  • ImClone Investigational Site

    Pretoria, 0081

  • ImClone Investigational Site

    Pretoria, 0181

  • ImClone Investigational Site

    Sandton, 2199

Other trials in South Africa

Brazil10 sites

  • ImClone Investigational Site

    Ijuí, 98700-000

  • ImClone Investigational Site

    Porto Alegre, 90035-001

  • ImClone Investigational Site

    Porto Alegre, 90430-090

  • ImClone Investigational Site

    Porto Alegre, 906-000

  • ImClone Investigational Site

    Rio de Janeiro, 21941-913

  • ImClone Investigational Site

    Santo André, 09060-650

  • ImClone Investigational Site

    São Paulo, 01318-000

  • ImClone Investigational Site

    São Paulo, 05651-901

  • ImClone Investigational Site

    São Paulo, 08270-070

  • ImClone Investigational Site

    São Paulo, 1246-000

Other trials in Brazil

Belgium8 sites

  • ImClone Investigational Site

    Brasschaat, 2930

  • ImClone Investigational Site

    Charleroi, 6000

  • ImClone Investigational Site

    Edegem, 2650

  • ImClone Investigational Site

    Ghent, 9000

  • ImClone Investigational Site

    Kortrijk, 8500

  • ImClone Investigational Site

    Liège, 4000

  • ImClone Investigational Site

    Namur, 5000

  • ImClone Investigational Site

    Yvoir, 5530

Other trials in Belgium

Canada7 sites

  • ImClone Investigational Site

    Calgary, Alberta, T2N4N2

  • ImClone Investigational Site

    Edmonton, Alberta, T6G 1Z2

  • ImClone Investigational Site

    Greenfield Park, Quebec

  • ImClone Investigational Site

    Québec, G1S 4L8

  • ImClone Investigational Site

    Toronto, Ontario, M4N 3M5

  • ImClone Investigational Site

    Vancouver, British Columbia, V5Z 4E6

  • ImClone Investigational Site

    Weston, Ontario, M9N 1N8

Other trials in Canada

Czechia7 sites

  • ImClone Investigational Site

    Brno, 62500

  • ImClone Investigational Site

    Kutná Hora, 28401

  • ImClone Investigational Site

    Pardubice, 532 03

  • ImClone Investigational Site

    Prague, Motol, 150 06

  • ImClone Investigational Site

    Prague, 14059

  • ImClone Investigational Site

    Prague, 180 80

  • ImClone Investigational Site

    Videnska, 14059

Other trials in Czechia

Peru6 sites

  • ImClone Investigational Site

    Arequipa, 054

  • ImClone Investigational Site

    Lima, Lima1

  • ImClone Investigational Site

    Lima, Lima27

  • ImClone Investigational Site

    Lima, Lima34

  • ImClone Investigational Site

    Lima, Lima41

  • ImClone Investigational Site

    Lima, Lime27

Other trials in Peru

United Kingdom6 sites

  • ImClone Investigational Site

    Bournemouth, BH7 7DW

  • ImClone Investigational Site

    Edinburgh, EH4 2XU

  • ImClone Investigational Site

    Huddersfield, HD3 3EA

  • ImClone Investigational Site

    Hull, HU16 5JQ

  • ImClone Investigational Site

    Manchester, M20 4BX

  • ImClone Investigational Site

    Nottingham, NG5 1PB

Other trials in United Kingdom

Ireland5 sites

  • ImClone Investigational Site

    Cork

  • ImClone Investigational Site

    Dublin, 7

  • ImClone Investigational Site

    Dublin

  • ImClone Investigational Site

    Erlangen

  • ImClone Investigational Site

    Limerick

Other trials in Ireland

Israel5 sites

  • ImClone Investigational Site

    Beersheva, 84101

  • ImClone Investigational Site

    Jerusalem, 91129

  • ImClone Investigational Site

    Petah Tikva, 49100

  • ImClone Investigational Site

    Rehovot, 76100

  • ImClone Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Lebanon5 sites

  • ImClone Investigational Site

    Beirut

  • ImClone Investigational Site

    Bsalîm

  • ImClone Investigational Site

    Metn

  • ImClone Investigational Site

    Sidon

  • ImClone Investigational Site

    Zghartā

Other trials in Lebanon

South Korea4 sites

  • ImClone Investigational Site

    Incheon, 400-711

  • ImClone Investigational Site

    Seoul, 110-744

  • ImClone Investigational Site

    Seoul, 120-752

  • ImClone Investigational Site

    Seoul, 135-710

Other trials in South Korea

Egypt3 sites

  • ImClone Investigational Site

    Alexandria, 21526

  • ImClone Investigational Site

    Cairo, 11796

  • ImClone Investigational Site

    Cairo, 16114

Other trials in Egypt

New Zealand3 sites

  • ImClone Investigational Site

    Auckland, 1023

  • ImClone Investigational Site

    Auckland

  • ImClone Investigational Site

    Palmerston North, 4414

Other trials in New Zealand

Poland3 sites

  • ImClone Investigational Site

    Bytom, 41-902

  • ImClone Investigational Site

    Olsztyn, 10-228

  • ImClone Investigational Site

    Olsztyn, 10-513

Other trials in Poland

Serbia3 sites

  • ImClone Investigational Site

    Kamenitz, 21204

  • ImClone Investigational Site

    Kragujevac, 34000

  • ImClone Investigational Site

    Niš, 18000

Other trials in Serbia

Slovakia3 sites

  • ImClone Investigational Site

    Bratislava, 81250

  • ImClone Investigational Site

    Trnava, 91775

  • ImClone Investigational Site

    Žilina

Other trials in Slovakia

Taiwan3 sites

  • ImClone Investigational Site

    Changhua, M20 4BX

  • ImClone Investigational Site

    Taipei

  • ImClone Investigational Site

    Taoyuan County, 33305

Other trials in Taiwan

Croatia1 site

  • ImClone Investigational Site

    Osijek, 3100

Other trials in Croatia

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
ramucirumab (IMC-1121B), docetaxel, Placebo
Keywords
Metastatic breast cancer, HER2 negative breast cancer, locally recurrent breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ramucirumab (IMC-1121B)Biological

    Also called IMC-1121B, LY3009806

    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.

  • docetaxelDrug

    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.

  • PlaceboOther

    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.

Study groups in NCT00703326
Study groupRoleWhat they receive
ramucirumab (IMC-1121B) + docetaxelExperimentalNot described
Receives: Biological: ramucirumab (IMC-1121B); Drug: docetaxel
placebo + docetaxelPlacebo comparatorNot described
Receives: Drug: docetaxel; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 56 months)

Secondary outcomes (8)

  1. 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.

    Measured: Randomization to death or until data cutoff of 29-May-2015 (up to 82 months)

  2. 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.

    Measured: Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months)

  3. 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.

    Measured: Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months)

  4. 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.

    Measured: Date of first CR or PR to PD or death or until data cutoff date of 31-Mar-2013 (up to 56 months)

  5. 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-QoL): 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.

    Measured: Baseline, End of Therapy or until data cutoff of 31-Mar-2013 (up to 56 months)

  6. 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.

    Measured: First dose to study completion (up to 12.3 years)

  7. Immunogenicity: Percentage of Participants With Treatment Emergent Anti-Ramucirumab Antibodies Until Primary Data Cutoff of 31-Mar-2013

    Percentage of participants with treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies during the study. Participants were considered positive for anti-ramucirumab (IMC-1121B) antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-ramucirumab (IMC-1121B) level seen in healthy untreated individuals.

    Measured: 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

  8. 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

    Percentage of participants with treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies during the study. Participants were considered positive for anti-ramucirumab (IMC-1121B) antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-ramucirumab (IMC-1121B) level seen in healthy untreated individuals.

    Measured: Follow-up from 01-Apr-2013 to 08-Sep-2016 (Up to 56 -97 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2008 (estimated)
  2. Study start6 Aug 2008
  3. Primary completion31 Mar 2013
  4. Study completion19 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00703326
Sponsor's protocol ID
13892
Other IDs
2008-001727-65, TRIO-012, TRIO-CIRG-012, CP12-0606, I4T-IE-JVBC, 2008
Status last verified
Nov 2021
First submitted
20 Jun 2008
Last updated
6 Dec 2021
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 28950290

  • 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.

    PubMed 28520849

  • 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.

    PubMed 25185099

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ramucirumab (IMC-1121B) and docetaxel in people with Breast Cancer, run by Eli Lilly and Company at 232 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in United States, Spain, Australia, Russia, Germany and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 56 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00703326, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.

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