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A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (MONARCH 2)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02107703
First Posted: April 8, 2014
Last Update Posted: June 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib+fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant.

Condition Intervention Phase
Breast Neoplasms Drug: Abemaciclib Drug: Fulvestrant Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline up to Approximately 31 Months ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline up to Approximately 80 Months ]
  • Objective Response Rate [ Time Frame: Baseline up to Approximately 31 Months ]
  • Duration of Response (DoR) [ Time Frame: Baseline up to Approximately 31 Months ]
  • Disease Control Rate (DCR) [ Time Frame: Baseline up to Approximately 31 Months ]
  • Clinical Benefit Rate (CBR) [ Time Frame: Baseline up to Approximately 31 Months ]
  • Change from Baseline in Pain and Symptom Burden Assessment Using the Brief Pain Inventory (BPI) [ Time Frame: Baseline, End of Study (up to approximately 31 months) ]
  • Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites, and Fulvestrant [ Time Frame: Baseline up to Approximately 31 Months ]
  • Change from Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L) [ Time Frame: Baseline, End of Study (up to approximately 31 months) ]
  • Change from Baseline in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline, End of Study (up to approximately 31 months) ]
  • Change from Baseline in Quality of Life Using the EORTC QLQ-BR23 (breast) Questionnaire [ Time Frame: Baseline, End of Study (up to approximately 31 months) ]

Estimated Enrollment: 630
Study Start Date: July 2014
Estimated Study Completion Date: February 2020
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abemaciclib + Fulvestrant
150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Administered Orally
Other Name: LY2835219
Drug: Fulvestrant
Administered IM
Placebo Comparator: Placebo + Fulvestrant
Placebo will be supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Fulvestrant
Administered IM
Drug: Placebo
Administered Orally

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Have a diagnosis of HR+, HER2- breast cancer
  • Have locally advanced disease not amenable to curative treatment by surgery or metastatic disease. In addition, participants must fulfill 1 of the following criteria:

    • relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
    • relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
    • relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
    • presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
  • Have postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin
  • Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
  • Have either measurable disease or nonmeasurable bone only disease
  • Have a performance status ≤1 on the ECOG scale
  • Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy

Exclusion Criteria

  • Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease
  • Have clinical evidence or history of central nervous system metastasis
  • Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor
  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
  • Have received recent (within 28 days prior to randomization) yellow fever vaccination
  • Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)
  • Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
  • Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
  • Have received an autologous or allogeneic stem-cell transplant
  • Have active bacterial or fungal infection, or detectable viral infection
  • Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B (RANK) ligand targeted agents <7 days prior to randomization
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107703


  Hide Study Locations
Locations
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
Clopton Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
Southern California Permanente Medical Group
Bellflower, California, United States, 90706
Univ of California San Francisco
San Francisco, California, United States, 94115
Southern California Permanente Medical Group
San Marcos, California, United States, 92078
Stanford University Clinic
Stanford, California, United States, 94305
United States, Colorado
Rocky Mountain Cancer Center
Aurora, Colorado, United States, 80012
United States, Florida
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, United States, 33308
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Advanced Medical Specialties
Miami, Florida, United States, 33176
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Palm Beach Cancer Institue
West Palm Beach, Florida, United States, 33401
United States, Georgia
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States, 30607
Harbin Clinic
Rome, Georgia, United States, 30165
United States, Illinois
Quincy Medical Group
Quincy, Illinois, United States, 62301
United States, Indiana
Community Clinical Research Center
Anderson, Indiana, United States, 46011
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Breslin Cancer Center
Lansing, Michigan, United States, 48910
United States, Minnesota
Minnesota Oncology/Hematology PA
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Freeman Cancer Institute
Joplin, Missouri, United States, 64804
St Lukes Hospital
Kansas City, Missouri, United States, 64111
Washington University Medical Center
Saint Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic Research Center
Billings, Montana, United States, 59101
United States, Nebraska
Oncology Hematology West
Omaha, Nebraska, United States, 68130
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
United States, New York
Mount Sinai School of Medicine Dermatology Clinical Trials
New York, New York, United States, 10029
Columbia University College of Phys & Surgeons
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Rochester General Hospital
Rochester, New York, United States, 14621
United States, North Carolina
Novant Health, Oncology Research Institute
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Sandford Research/USD
Sioux Falls, North Dakota, United States, 57104
SMO Sanford Research
Sioux Falls, North Dakota, United States, 57104
United States, Oklahoma
Tulsa Cancer Institute, PLLC
Tulsa, Oklahoma, United States, 74146
United States, South Dakota
Sanford Research/USD
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
The Jones Clinic
Germantown, Tennessee, United States, 38138
The Boston Baskin Cancer Group
Memphis, Tennessee, United States, 38120
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Bedford, Texas, United States, 76022
Texas Oncology Fort Worth
Fort Worth, Texas, United States, 76104
Texas Oncology-Memorial City
Houston, Texas, United States, 77024
Baylor College of Medicine
Houston, Texas, United States, 77030
Oncology Consultants Cancer Center
Houston, Texas, United States, 77030
Texas Oncology-Plano East
Plano, Texas, United States, 75075
SMO US Oncology
The Woodlands, Texas, United States, 77380
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05405
United States, Virginia
Oncology and Hematology Associates of Southwest Virginia Inc
Salem, Virginia, United States, 24153
United States, Washington
Columbia Basin Hematology & Oncology
Kennewick, Washington, United States, 99336
St Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
Australia
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East Bentleigh, Australia, 3165
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Kurralta Park, Australia, 5037
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South Brisbane, Australia, 4101
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Southport, Australia, 4215
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Subiaco, Australia, 6008
Belgium
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Brussel, Belgium, 1090
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Edegem, Belgium, 2650
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Leuven, Belgium, 3000
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Liège, Belgium, 4000
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
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London, Ontario, Canada, N6A 4L6
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Toronto, Ontario, Canada, M5B 1W8
Denmark
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Aalborg, Denmark, DK-9000
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Herlev, Denmark, 2730
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Roskilde, Denmark, 4000
Finland
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Oulu, Finland, 90210
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Tampere, Finland, 33521
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Turku, Finland, 20520
France
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Besancon, France, 25030
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Clermont-Ferrand, France
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La Chaussee Saint Victor, France, 41260
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Le Mans, France, 72000
Germany
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Augsburg, Germany, 86150
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Hamburg, Germany, 20249
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Ludwigsburg, Germany, 71640
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Munich, Germany, 80337
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Tübingen, Germany, 72076
Greece
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Athens, Greece, 11522
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Chania, Greece, 73300
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Heraklion, Greece, 71110
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Patras, Greece, 26504
Italy
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Bologna, Italy, 40139
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Cona, Italy, 44124
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Padova, Italy, 35128
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Rome, Italy, 00144
Japan
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Bunkyo-ku, Japan, 113-8677
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Chiba, Japan, 260-8717
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Chuo-Ku, Japan, 104-0045
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Fukuoka, Japan, 830-0013
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Kagoshima, Japan, 892-0833
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Kashiwa, Japan, 277 8577
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Kawasaki, Japan, 216-8511
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Kitaadachi-Gun, Japan, 362-0806
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Koto-ku, Japan, 135-8550
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Kurume, Japan, 830-0013
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Kyoto, Japan, 606-8507
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Matsuyama, Japan, 791-0280
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Nagoya, Japan, 464-8681
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Niigata, Japan, 951-8566
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Nishinomiya, Japan, 663-8501
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Osaka, Japan, 540-0006
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Sapporo, Japan, 003-0804
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Shimotsuke, Japan, 329- 0498
Korea, Republic of
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Chungbuk, Korea, Republic of, 361-711
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Gyeonggi-Do, Korea, Republic of, 463-070
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Incheon, Korea, Republic of, 400-711
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Seoul, Korea, Republic of, 138-736
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Ulsan-Si, Korea, Republic of, 682-714
Mexico
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Leon, Mexico, 37000
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Mexico City, Mexico, 14080
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Mexico, Mexico, 03310
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Monterrey, Mexico, 64710
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Nuevo Leon, Mexico, 64060
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Tijuana, Mexico, 22010
Poland
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Bialystok, Poland, 15-027
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Gdansk, Poland, 80-952
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Lodz, Poland, 90-242
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Wieliszew, Poland, 05-135
Puerto Rico
Puerto Rico Hematology/Oncology Group
Bayamon, Puerto Rico, 00959
Romania
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Bucharest, Romania, 010976
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Cluj-Napoca, Romania, 400058
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Craiova, Romania, 200347
Russian Federation
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Arkhangelsk, Russian Federation, 163045
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Kursk, Russian Federation, 305035
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Moscow, Russian Federation, 115478
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St Petersburg, Russian Federation, 197022
Spain
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Barcelona, Spain, 08035
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Elche, Spain, 03202
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Lleida, Spain, 25198
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Madrid, Spain, 28041
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Murcia, Spain, 30008
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Valencia, Spain, 46015
Switzerland
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Basel, Switzerland, CH-4031
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Genève, Switzerland, 1211
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Thun, Switzerland, 3600
Taiwan
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Kaohsiung, Taiwan, 813
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Kuei Shan Hsiang, Taiwan, 33305
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Taichung, Taiwan, 404
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Taipei, Taiwan, 11217
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Taoyuan, Taiwan, 33378
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02107703     History of Changes
Other Study ID Numbers: 15362
I3Y-MC-JPBL ( Other Identifier: Eli Lilly and Company )
2013-004728-13 ( EudraCT Number )
First Submitted: April 4, 2014
First Posted: April 8, 2014
Last Update Posted: June 15, 2017
Last Verified: June 2017

Keywords provided by Eli Lilly and Company:
MONARCH 2

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Estradiol
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Estrogens