Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer
NCT ID: NCT01151046
Last Updated: 2016-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
118 participants
INTERVENTIONAL
2010-06-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MM-121 (SAR256212) + exemestane
MM-121
MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week
Exemestane
Exemestane (25 mg) administered orally once per day
Placebo + exemestane
Placebo
Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day
Exemestane
Exemestane (25 mg) administered orally once per day
Interventions
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MM-121
MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week
Placebo
Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day
Exemestane
Exemestane (25 mg) administered orally once per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast cancer
* ≥ 18 years of age
Exclusion Criteria
* Extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases)
* Symptomatic CNS disease
18 Years
FEMALE
No
Sponsors
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Merrimack Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Victor Moyo, MD
Role: STUDY_DIRECTOR
Merrimack Pharmaceuticals, Inc.
Locations
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Achieve Clinical Research
Birmingham, Alabama, United States
Achieve Clinical Research
Birmingham, Alabama, United States
Arizona Center for Cancer Care
Glendale, Arizona, United States
Pacific Cancer Medical Center
Anaheim, California, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
Wilshire Oncology Medical Group, Inc.
Corona, California, United States
Southwest Cancer Center
Escondido, California, United States
Hematology Oncology Associates, INC.
Oakland, California, United States
San Jose Medical Center
San Jose, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
Pasco-Pinellas Oncology
New Port Richey, Florida, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Horizon Oncology Center
Lafayette, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Tennessee Cancer Specialists Oncology Clinical Trials Center for Biomedical Research
Knoxville, Tennessee, United States
Tennessee Cancer Specialists, Oncology Clincial Trials Center for Biomedical Research
Knoxville, Tennessee, United States
Hopital Maissoneuve-Rosemont
Montreal, Quebec, Canada
McGill University Jewish General Hospital
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, , Canada
CHA St. Sacrement
Québec, , Canada
Onkogologisches zentrum Munich
Munich, , Germany
Brustzentrum HS Kliniken Wiesbaden
Wiesbaden, , Germany
Medico-Diagnostically Center of International Institution of biological systems n.a.S.M.
Berezina, , Russia
Railway Clinical Hospital
Saint Petersburg, , Russia
Leningrad Regional Oncology Center
Saint Petersburg, , Russia
City Clinical Oncology Center
Saint Petersburg, , Russia
Vall d'Hebrón University Hospital
Barcelona, , Spain
Hospital Clinic (Barcelona)
Barcelona, , Spain
Hospital Parc Tauli - Barcelona
Barcelona, , Spain
Servicio de Oncología Médica / Hospital Universitario Gregorio Marañón
Madrid, , Spain
Puerta de Hierro
Madrid, , Spain
Countries
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Other Identifiers
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MM-121-02-02-03 (ARD11588)
Identifier Type: -
Identifier Source: org_study_id
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