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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:August 6, 2008
End Date:January 1, 2020

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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.

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.

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
We found this trial at
56
sites
Lansing, Michigan 48912
207
mi
from 43215
Lansing, MI
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Alhambra, California 91801
1965
mi
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Alhambra, CA
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Alton, Illinois 62002
387
mi
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Alton, IL
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Atlanta, Georgia 30341
425
mi
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Atlanta, GA
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Aurora, Colorado 80045
1154
mi
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Aurora, CO
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Bakersfield, California 93309
1980
mi
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Bakersfield, CA
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Bartlett, Tennessee 38133
495
mi
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Bartlett, TN
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Birmingham, Alabama 35202
493
mi
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Birmingham, AL
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Bismarck, North Dakota 58501
1006
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Bismarck, ND
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Chandler, Arizona 85224
1654
mi
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Chandler, AZ
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Charlotte, North Carolina 28203
349
mi
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Charlotte, NC
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Chicago, Illinois 60076
274
mi
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Chicago, IL
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Chula Vista, California 91911
1949
mi
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Chula Vista, CA
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Elkhart, Indiana 46514
194
mi
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Elkhart, IN
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Fitzroy, Victoria 3065
9881
mi
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Fitzroy,
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Fort Lauderdale, Florida 33308
966
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Fort Lauderdale, FL
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Gainesville, Florida 32605
711
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Gainesville, FL
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Germantown, Tennessee 38138
501
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Germantown, TN
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Gilbert, Arizona 85297
1650
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Gilbert, AZ
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Grand Island, Nebraska 68803
807
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Grand Island, NE
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Henderson, Nevada 89052
1758
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Henderson, NV
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Kearney, Nebraska 68845
846
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Kearney, NE
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La Mesa, California 91942
1942
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La Mesa, CA
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Lexington, Kentucky 40604
157
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Lexington, KY
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Los Angeles, California 90095
1972
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Los Angeles, CA
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Lubbock, Texas 79410
1131
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Lubbock, TX
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Macon, Georgia 31217
489
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Macon, GA
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Marietta, Georgia 30060
423
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Marietta, GA
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Memphis, Tennessee 38120
502
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Memphis, TN
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Mesa, Arizona 85206
1650
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Mesa, AZ
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Minneapolis, Minnesota 55415
625
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Minneapolis, MN
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Mishawaka, Indiana 46545
201
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Mishawaka, IN
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Mobile, Alabama 36608
707
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Mobile, AL
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New Port Richey, Florida 34655
814
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New Port Richey, FL
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New York, New York 10011
477
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New York, NY
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Niles, Tennessee 49120
210
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Niles, TN
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Oceanside, California 92056
1949
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Oceanside, CA
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Oklahoma City, Oklahoma 73120
849
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Oklahoma City, OK
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Oxford, Tennessee 38655
527
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Oxford, TN
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Pasadena, California 01107
1964
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Portland, Oregon 97239
2027
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Portland, OR
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Saint Joseph, Michigan 49085
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Saint Joseph, MI
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Saint Louis, Missouri 63110
394
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Saint Louis, MO
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Salt Lake City, Utah 84106
1513
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San Diego, California 92123
1947
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San Diego, CA
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Santa Barbara, California 93105
2039
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Santa Maria, California 93454
2065
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Santa Maria, CA
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Santa Monica, California 90404
1984
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Santa Monica, CA
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Skokie, Illinois 60076
284
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Skokie, IL
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Solvang, California 93463
2058
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South Bend, Indiana 46601
205
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South Bend, IN
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Southaven, Mississippi 38671
514
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Southaven, MS
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Temple, Texas 76508
1011
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Temple, TX
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Valencia, California 91355
1980
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Valencia, CA
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West Reading, Pennsylvania 19611
374
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West Reading, PA
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Westville, Indiana 46891
230
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Westville, IN
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