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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02107703
Recruitment Status : Recruiting
First Posted : April 8, 2014
Results First Posted : March 13, 2018
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

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.

For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Abemaciclib Drug: Fulvestrant Drug: Placebo Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 669 participants
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
Actual Study Start Date : July 22, 2014
Actual Primary Completion Date : February 14, 2017
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: Abemaciclib + Fulvestrant (Endocrine Naïve Cohort)
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




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]
    PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From Date of Randomization until Death Due to Any Cause (Up To 80 Months) ]
    OS defined as the time from the date of randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.

  2. Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]
    ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

  3. Duration of Response (DOR) [ Time Frame: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]
    DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

  4. Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR]) [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]
    Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

  5. Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR]) [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]
    Clinical benefit rate defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months.CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants=(participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.PD was at least a 20% increase in sum of the diameters of target lesions,with reference being the smallest sum on study and an absolute increase of at least 5 mm or unequivocal progression of non-target lesions,or 1 or more new lesions.

  6. Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf) [ Time Frame: Baseline, End of Study (Up To 31 Months) ]
    A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. Least square (LS) Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.

  7. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20 [ Time Frame: Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose ]
    Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20.

  8. Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L) [ Time Frame: Baseline, End of Study (Up To 31 Months) ]
    European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.

  9. Change From Baseline to Short Term Follow up 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, Short Term Follow Up (Up To 31 Months) ]
    EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 110 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.

  10. Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire [ Time Frame: Baseline, Short Term Follow Up (Up To 31 Months) ]
    EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms and arm symptoms. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
    • for the endocrine naïve cohort: Must not have received prior endocrine therapy in current or prior disease setting
  • 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. For the endocrine naïve cohort: In addition, have received treatment with any prior endocrine therapy
  • 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

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


Contacts
Layout table for location contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

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Locations
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United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
Contact    479-587-1700      
Principal Investigator: Joseph Beck         
Clopton Clinic Recruiting
Jonesboro, Arkansas, United States, 72401
Contact    870-932-5296      
Principal Investigator: Mazen Khalil         
United States, California
Southern California Permanente Medical Group Recruiting
Bellflower, California, United States, 90706
Contact    619-641-2675      
Principal Investigator: Han Koh         
Univ of California San Francisco Recruiting
San Francisco, California, United States, 94115
Contact    415-353-7288      
Principal Investigator: Hope Rugo         
Southern California Permanente Medical Group Active, not recruiting
San Marcos, California, United States, 92078
Stanford University Clinic Recruiting
Stanford, California, United States, 94305
Contact    650-725-5295      
Principal Investigator: George Sledge         
United States, Colorado
Rocky Mountain Cancer Center Recruiting
Aurora, Colorado, United States, 80012
Contact    303-418-7639      
Principal Investigator: Sami Diab         
United States, Florida
Holy Cross Hospital Inc. Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact    954-771-8000      
Principal Investigator: Zdenka Segota         
Florida Cancer Specialists Recruiting
Fort Myers, Florida, United States, 33916
Contact    239-275-6400      
Principal Investigator: Lowell Hart         
Advanced Medical Specialties Recruiting
Miami, Florida, United States, 33176
Contact    305-595-2141      
Principal Investigator: Grace Wang         
Florida Cancer Specialists Recruiting
Saint Petersburg, Florida, United States, 33705
Contact    727-216-1143      
Principal Investigator: Gail Wright         
H Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact    813-745-3522      
Principal Investigator: Hatem Soliman         
Palm Beach Cancer Institue Recruiting
West Palm Beach, Florida, United States, 33401
Contact    561-366-4149      
Principal Investigator: Marilyn Raymond         
United States, Georgia
Northeast Georgia Cancer Care, LLC Recruiting
Athens, Georgia, United States, 30607
Contact    706-353-2990      
Principal Investigator: Petros Nikolinakos         
Harbin Clinic Recruiting
Rome, Georgia, United States, 30165
Contact    706-528-9110      
Principal Investigator: Dilawar Khan         
United States, Illinois
Quincy Medical Group Recruiting
Quincy, Illinois, United States, 62301
Contact    217-277-3500      
Principal Investigator: Karthik Koduru         
United States, Indiana
Community Clinical Research Center Recruiting
Anderson, Indiana, United States, 46011
Contact    765-298-2040      
Principal Investigator: Shiroo Parshad         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact    617-632-5869      
Principal Investigator: Sara Tolaney         
United States, Michigan
Breslin Cancer Center Recruiting
Lansing, Michigan, United States, 48910
Contact    517-975-9547      
Principal Investigator: Deimante Tamkus         
United States, Minnesota
Minnesota Oncology/Hematology PA Recruiting
Minneapolis, Minnesota, United States, 55404
Contact    612-884-6300      
Principal Investigator: Michaela Tsai         
United States, Missouri
Freeman Cancer Institute Recruiting
Joplin, Missouri, United States, 64804
Contact    417-347-4000      
Principal Investigator: Govinda Brahmanday         
St Lukes Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact    816-932-3300      
Principal Investigator: Timothy Pluard         
Washington University Medical Center Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic Research Center Recruiting
Billings, Montana, United States, 59101
Contact    406-238-2500      
Principal Investigator: BROCK WHITTENBERGER         
United States, Nebraska
Oncology Hematology West Recruiting
Omaha, Nebraska, United States, 68130
Contact    402-691-6971      
Principal Investigator: Margaret Block         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0001
Contact    603-653-6181      
Principal Investigator: Peter Kaufman         
United States, New York
Mount Sinai School of Medicine Dermatology Clinical Trials Recruiting
New York, New York, United States, 10029
Contact    212-241-3300      
Principal Investigator: Amy Tiersten         
Columbia University College of Phys & Surgeons Recruiting
New York, New York, United States, 10032
Contact    212-305-1945      
Principal Investigator: Kevin Kalinsky         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact    646-888-4545      
Principal Investigator: Maura Dickler         
Rochester General Hospital Completed
Rochester, New York, United States, 14621
United States, North Carolina
Novant Health, Oncology Research Institute Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact    336-277-8800      
Principal Investigator: Judith Hopkins         
United States, North Dakota
Sandford Research/USD Not yet recruiting
Sioux Falls, North Dakota, United States, 57104
Principal Investigator: Sanford Research         
SMO Sanford Research Recruiting
Sioux Falls, North Dakota, United States, 57104
Contact    6053281379      
Principal Investigator: Miroslaw Mazurczak         
United States, Oklahoma
Tulsa Cancer Institute, PLLC Recruiting
Tulsa, Oklahoma, United States, 74146
Contact    918-505-3201      
Principal Investigator: Kevin Weibel         
United States, South Dakota
Sanford Research/USD Not yet recruiting
Sioux Falls, South Dakota, United States, 57104
Principal Investigator: Sanford Research         
United States, Tennessee
The Jones Clinic Recruiting
Germantown, Tennessee, United States, 38138
Contact    901-685-5969 ext 322      
Principal Investigator: Clyde Jones         
The Boston Baskin Cancer Group Recruiting
Memphis, Tennessee, United States, 38120
Contact    901-226-1493      
Principal Investigator: Michael Magee         
SMO Sarah Cannon Research Inst. Recruiting
Nashville, Tennessee, United States, 37203
Contact    615-239-7615      
Principal Investigator: Sarah Cannon Research Inst.         
United States, Texas
Texas Oncology Cancer Center Recruiting
Austin, Texas, United States, 78731
Contact    512-427-9400      
Principal Investigator: Debra Patt         
Texas Oncology-Baylor Charles A. Sammons Cancer Center Recruiting
Bedford, Texas, United States, 76022
Contact    817-359-9089      
Principal Investigator: Thomas Anderson         
Texas Oncology Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Contact    817-850-2011      
Principal Investigator: Sanjay Oommen         
Texas Oncology-Memorial City Recruiting
Houston, Texas, United States, 77024
Contact    713-467-1722      
Principal Investigator: Frankie Holmes         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact    713-798-2400      
Principal Investigator: Polly Niravath         
Oncology Consultants Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact    713-275-3208      
Principal Investigator: Julio Peguero         
Texas Oncology-Plano East Recruiting
Plano, Texas, United States, 75075
Contact    972-867-3577      
Principal Investigator: Christopher Stokoe         
SMO US Oncology Recruiting
The Woodlands, Texas, United States, 77380
Contact    281-863-1000      
Principal Investigator: US Oncology         
Tyler Cancer Center Recruiting
Tyler, Texas, United States, 75702
Contact    903-592-6114      
Principal Investigator: Svetislava Vukelja         
United States, Utah
Utah Cancer Specialists Recruiting
Salt Lake City, Utah, United States, 84106
Contact    801-270-2238      
Principal Investigator: Stephan Kendall         
United States, Vermont
Fletcher Allen Health Care Recruiting
Burlington, Vermont, United States, 05405
Contact    802-847-2610      
Principal Investigator: Farrah Khan         
United States, Virginia
Oncology and Hematology Associates of Southwest Virginia Inc Recruiting
Salem, Virginia, United States, 24153
Contact    540-774-8660      
Principal Investigator: Paul Richards         
United States, Washington
Columbia Basin Hematology & Oncology Recruiting
Kennewick, Washington, United States, 99336
Contact    509-783-4637      
Principal Investigator: Thomas Rado         
St Mary Regional Cancer Center Recruiting
Walla Walla, Washington, United States, 99362
Contact    509-522-5993      
Principal Investigator: James Cunningham         
Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
East Bentleigh, Australia, 3165
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
Kurralta Park, Australia, 5037
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
South Brisbane, Australia, 4101
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
Southport, Australia, 4215
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
Subiaco, Australia, 6008
Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
Brussel, Belgium, 1090
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
Edegem, Belgium, 2650
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
Leuven, Belgium, 3000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
Liège, Belgium, 4000
Canada, Alberta
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Eli Lilly and Company         
Canada, Ontario
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Eli Lilly and Company         
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Eli Lilly and Company         
Denmark
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
Aalborg, Denmark, DK-9000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
Herlev, Denmark, 2730
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
Roskilde, Denmark, 4000
Finland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Active, not recruiting
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
Contact: Eli Lilly and Company         
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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
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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
Contact: Eli Lilly and Company         
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
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Puerto Rico
Puerto Rico Hematology/Oncology Group Recruiting
Bayamon, Puerto Rico, 00959
Contact    7877868088      
Principal Investigator: Robert Hunter-Mellado         
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
Contact: Eli Lilly and Company         
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Lleida, Spain, 25198
Contact: Eli Lilly and Company         
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Madrid, Spain, 28041
Contact: Eli Lilly and Company         
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Murcia, Spain, 30008
Contact: Eli Lilly and Company         
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Valencia, Spain, 46015
Contact: Eli Lilly and Company         
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
Contact: Eli Lilly and Company         
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Kuei Shan Hsiang, Taiwan, 33305
Contact: Eli Lilly and Company         
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Taichung, Taiwan, 404
Contact: Eli Lilly and Company         
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Taipei, Taiwan, 11217
Contact: Eli Lilly and Company         
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Taoyuan, Taiwan, 33378
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal 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 Posted: April 8, 2014    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

Keywords provided by Eli Lilly and Company:
MONARCH 2

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