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

Primary Purpose

Breast Neoplasms

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Abemaciclib

Fulvestrant

Placebo

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring MONARCH 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Highlands Oncology Group
Clopton Clinic
Southern California Permanente Medical Group
Univ of California San Francisco
Southern California Permanente Medical Group
Stanford University Clinic
Rocky Mountain Cancer Center
Holy Cross Hospital Inc.
Florida Cancer Specialists
Advanced Medical Specialties
Florida Cancer Specialists
H Lee Moffitt Cancer Center
Palm Beach Cancer Institue
Northeast Georgia Cancer Care, LLC
Harbin Clinic
Quincy Medical Group
Community Clinical Research Center
Dana Farber Cancer Institute
Breslin Cancer Center
Minnesota Oncology/Hematology PA
Freeman Cancer Institute
St Lukes Hospital
Washington University Medical Center
Billings Clinic Research Center
Oncology Hematology West
Dartmouth Hitchcock Medical Center
Mount Sinai School of Medicine Dermatology Clinical Trials
Columbia University College of Phys & Surgeons
Memorial Sloan Kettering Cancer Center
Rochester General Hospital
Novant Health, Oncology Research Institute
Sandford Research/USD
SMO Sanford Research
Tulsa Cancer Institute, PLLC
Sanford Research/USD
The Jones Clinic
The Boston Baskin Cancer Group
SMO Sarah Cannon Research Inst.
Texas Oncology Cancer Center
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Texas Oncology Fort Worth
Texas Oncology-Memorial City
Baylor College of Medicine
Oncology Consultants Cancer Center
Texas Oncology-Plano East
SMO US Oncology
Tyler Cancer Center
Utah Cancer Specialists
Fletcher Allen Health Care
Oncology and Hematology Associates of Southwest Virginia Inc
Columbia Basin Hematology & Oncology
St Mary Regional Cancer Center
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Puerto Rico Hematology/Oncology Group
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Abemaciclib + Fulvestrant

Placebo + Fulvestrant

Abemaciclib + Fulvestrant (Endocrine Naïve Cohort)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)

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

Overall Survival (OS)

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.

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

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.

Duration of Response (DOR)

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.

Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])

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.

Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR])

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.

Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)

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.

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20

Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20.

Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)

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.

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)

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.

Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire

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.

Full Information

NCT ID

NCT02107703

First Posted

April 4, 2014

Last Updated

April 16, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02107703

Brief Title

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

Acronym

MONARCH 2

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 22, 2014 (Actual)

Primary Completion Date

February 14, 2017 (Actual)

Study Completion Date

January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

Keywords

MONARCH 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

669 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abemaciclib + Fulvestrant

Arm Type

Experimental

Arm Description

Arm Title

Placebo + Fulvestrant

Arm Type

Placebo Comparator

Arm Description

Arm Title

Abemaciclib + Fulvestrant (Endocrine Naïve Cohort)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Abemaciclib

Other Intervention Name(s)

LY2835219

Intervention Description

Administered Orally

Intervention Type

Drug

Intervention Name(s)

Fulvestrant

Intervention Description

Administered IM

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered Orally

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

Time Frame

From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

From Date of Randomization until Death Due to Any Cause (Up To 80 Months)

Title

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

Description

Time Frame

From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)

Title

Duration of Response (DOR)

Description

Time Frame

From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months)

Title

Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])

Description

Time Frame

From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)

Title

Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR])

Description

Time Frame

From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)

Title

Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)

Description

Time Frame

Baseline, End of Study (Up To 31 Months)

Title

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20

Description

Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and 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

Title

Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)

Description

Time Frame

Baseline, End of Study (Up To 31 Months)

Title

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)

Description

Time Frame

Baseline, Short Term Follow Up (Up To 31 Months)

Title

Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire

Description

Time Frame

Baseline, Short Term Follow Up (Up To 31 Months)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Highlands Oncology Group

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

Clopton Clinic

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

Southern California Permanente Medical Group

City

Bellflower

State/Province

California

ZIP/Postal Code

90706

Country

United States

Facility Name

Univ of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Southern California Permanente Medical Group

City

San Marcos

State/Province

California

ZIP/Postal Code

92078

Country

United States

Facility Name

Stanford University Clinic

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Rocky Mountain Cancer Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

Holy Cross Hospital Inc.

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Florida Cancer Specialists

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Advanced Medical Specialties

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Florida Cancer Specialists

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

H Lee Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Palm Beach Cancer Institue

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Northeast Georgia Cancer Care, LLC

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Harbin Clinic

City

Rome

State/Province

Georgia

ZIP/Postal Code

30165

Country

United States

Facility Name

Quincy Medical Group

City

Quincy

State/Province

Illinois

ZIP/Postal Code

62301

Country

United States

Facility Name

Community Clinical Research Center

City

Anderson

State/Province

Indiana

ZIP/Postal Code

46011

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Breslin Cancer Center

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Minnesota Oncology/Hematology PA

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

Freeman Cancer Institute

City

Joplin

State/Province

Missouri

ZIP/Postal Code

64804

Country

United States

Facility Name

St Lukes Hospital

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Washington University Medical Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Billings Clinic Research Center

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

Oncology Hematology West

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

Dartmouth Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756-0001

Country

United States

Facility Name

Mount Sinai School of Medicine Dermatology Clinical Trials

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Columbia University College of Phys & Surgeons

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Rochester General Hospital

City

Rochester

State/Province

New York

ZIP/Postal Code

14621

Country

United States

Facility Name

Novant Health, Oncology Research Institute

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Sandford Research/USD

City

Sioux Falls

State/Province

North Dakota

ZIP/Postal Code

57104

Country

United States

Facility Name

SMO Sanford Research

City

Sioux Falls

State/Province

North Dakota

ZIP/Postal Code

57104

Country

United States

Facility Name

Tulsa Cancer Institute, PLLC

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74146

Country

United States

Facility Name

Sanford Research/USD

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57104

Country

United States

Facility Name

The Jones Clinic

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

The Boston Baskin Cancer Group

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

SMO Sarah Cannon Research Inst.

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Texas Oncology Cancer Center

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Texas Oncology-Baylor Charles A. Sammons Cancer Center

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

Facility Name

Texas Oncology Fort Worth

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Texas Oncology-Memorial City

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Oncology Consultants Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Texas Oncology-Plano East

City

Plano

State/Province

Texas

ZIP/Postal Code

75075

Country

United States

Facility Name

SMO US Oncology

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

Tyler Cancer Center

City

Tyler

State/Province

Texas

ZIP/Postal Code

75702

Country

United States

Facility Name

Utah Cancer Specialists

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Fletcher Allen Health Care

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05405

Country

United States

Facility Name

Oncology and Hematology Associates of Southwest Virginia Inc

City

Salem

State/Province

Virginia

ZIP/Postal Code

24153

Country

United States

Facility Name

Columbia Basin Hematology & Oncology

City

Kennewick

State/Province

Washington

ZIP/Postal Code

99336

Country

United States

Facility Name

St Mary Regional Cancer Center

City

Walla Walla

State/Province

Washington

ZIP/Postal Code

99362

Country

United States

Facility Name

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.

City

East Bentleigh

ZIP/Postal Code

3165

Country

Australia

Facility Name

City

Kurralta Park

ZIP/Postal Code

5037

Country

Australia

Facility Name

City

South Brisbane

ZIP/Postal Code

4101

Country

Australia

Facility Name

City

Southport

ZIP/Postal Code

4215

Country

Australia

Facility Name

City

Subiaco

ZIP/Postal Code

6008

Country

Australia

Facility Name

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

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.

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

City

Aalborg

ZIP/Postal Code

DK-9000

Country

Denmark

Facility Name

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Facility Name

City

Oulu

ZIP/Postal Code

90210

Country

Finland

Facility Name

City

Tampere

ZIP/Postal Code

33521

Country

Finland

Facility Name

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

City

Clermont-Ferrand

Country

France

Facility Name

City

La Chaussee Saint Victor

ZIP/Postal Code

41260

Country

France

Facility Name

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

City

Ludwigsburg

ZIP/Postal Code

71640

Country

Germany

Facility Name

City

Munich

ZIP/Postal Code

80337

Country

Germany

Facility Name

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

City

Athens

ZIP/Postal Code

11522

Country

Greece

Facility Name

City

Chania

ZIP/Postal Code

73300

Country

Greece

Facility Name

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

City

Patras

ZIP/Postal Code

26504

Country

Greece

Facility Name

City

Bologna

ZIP/Postal Code

40139

Country

Italy

Facility Name

City

Cona

ZIP/Postal Code

44124

Country

Italy

Facility Name

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

City

Rome

ZIP/Postal Code

00144

Country

Italy

Facility Name

City

Bunkyo-ku

ZIP/Postal Code

113-8677

Country

Japan

Facility Name

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

City

Chuo-Ku

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

830-0013

Country

Japan

Facility Name

City

Kagoshima

ZIP/Postal Code

892-0833

Country

Japan

Facility Name

City

Kashiwa

ZIP/Postal Code

277 8577

Country

Japan

Facility Name

City

Kawasaki

ZIP/Postal Code

216-8511

Country

Japan

Facility Name

City

Kitaadachi-Gun

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

City

Koto-ku

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

City

Kurume

ZIP/Postal Code

830-0013

Country

Japan

Facility Name

City

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

City

Matsuyama

ZIP/Postal Code

791-0280

Country

Japan

Facility Name

City

Nagoya

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

City

Niigata

ZIP/Postal Code

951-8566

Country

Japan

Facility Name

City

Nishinomiya

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

540-0006

Country

Japan

Facility Name

City

Sapporo

ZIP/Postal Code

003-0804

Country

Japan

Facility Name

City

Shimotsuke

ZIP/Postal Code

329- 0498

Country

Japan

Facility Name

City

Chungbuk

ZIP/Postal Code

361-711

Country

Korea, Republic of

Facility Name

City

Gyeonggi-Do

ZIP/Postal Code

463-070

Country

Korea, Republic of

Facility Name

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

City

Ulsan-Si

ZIP/Postal Code

682-714

Country

Korea, Republic of

Facility Name

City

Leon

ZIP/Postal Code

37000

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

14080

Country

Mexico

Facility Name

City

Mexico

ZIP/Postal Code

03310

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64710

Country

Mexico

Facility Name

City

Nuevo Leon

ZIP/Postal Code

64060

Country

Mexico

Facility Name

City

Tijuana

ZIP/Postal Code

22010

Country

Mexico

Facility Name

City

Bialystok

ZIP/Postal Code

15-027

Country

Poland

Facility Name

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

City

Wieliszew

ZIP/Postal Code

05-135

Country

Poland

Facility Name

Puerto Rico Hematology/Oncology Group

City

Bayamon

ZIP/Postal Code

00959

Country

Puerto Rico

Facility Name

City

Bucharest

ZIP/Postal Code

010976

Country

Romania

Facility Name

City

Cluj-Napoca

ZIP/Postal Code

400058

Country

Romania

Facility Name

City

Craiova

ZIP/Postal Code

200347

Country

Romania

Facility Name

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

City

Kursk

ZIP/Postal Code

305035

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

City

St Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

City

Elche

ZIP/Postal Code

03202

Country

Spain

Facility Name

City

Lleida

ZIP/Postal Code

25198

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

City

Murcia

ZIP/Postal Code

30008

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46015

Country

Spain

Facility Name

City

Basel

ZIP/Postal Code

CH-4031

Country

Switzerland

Facility Name

City

Genève

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

City

Thun

ZIP/Postal Code

3600

Country

Switzerland

Facility Name

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

Facility Name

City

Kuei Shan Hsiang

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

City

Taoyuan

ZIP/Postal Code

33378

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

34425869

Citation

Neven P, Rugo HS, Tolaney SM, Iwata H, Toi M, Goetz MP, Kaufman PA, Lu Y, Haddad N, Hurt KC, Sledge GW Jr. Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. Breast Cancer Res. 2021 Aug 23;23(1):87. doi: 10.1186/s13058-021-01463-2.

Results Reference

derived

PubMed Identifier

33797023

Citation

Inoue K, Masuda N, Iwata H, Takahashi M, Ito Y, Miyoshi Y, Nakayama T, Mukai H, van der Walt JS, Mori J, Sakaguchi S, Kawaguchi T, Tanizawa Y, Llombart-Cussac A, Sledge GW Jr, Toi M. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. Breast Cancer. 2021 Sep;28(5):1038-1050. doi: 10.1007/s12282-021-01239-8. Epub 2021 Apr 1.

Results Reference

derived

PubMed Identifier

33392835

Citation

Goetz MP, Okera M, Wildiers H, Campone M, Grischke EM, Manso L, Andre VAM, Chouaki N, San Antonio B, Toi M, Sledge GW Jr. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021 Apr;186(2):417-428. doi: 10.1007/s10549-020-06029-y. Epub 2021 Jan 3.

Results Reference

derived

PubMed Identifier

31563959

Citation

Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A. The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):116-124. doi: 10.1001/jamaoncol.2019.4782.

Results Reference

derived

PubMed Identifier

28580882

Citation

Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017 Sep 1;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585. Epub 2017 Jun 3.

Results Reference

derived

Learn more about this trial

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

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