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CDK4/6 Inhibitor
Abemaciclib + Tamoxifen for Metastatic Breast Cancer (Next MONARCH 1 Trial)
Phase 2
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a diagnosis of HR+, HER2- breast cancer.
Relapsed or progressed following endocrine therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to death from any cause (approximately 36 months)
Awards & highlights
Next MONARCH 1 Trial Summary
This trial is testing abemaciclib, a new cancer drug, to see if it is safe and effective in treating women with metastatic breast cancer that is hormone receptor-positive and human epidermal growth factor receptor 2 negative.
Who is the study for?
This trial is for women with HR+, HER2- metastatic breast cancer who've had at least two chemotherapy regimens, one of which may have been in the metastatic setting. Participants must have recovered from previous treatments, be able to swallow pills, and not be pregnant. They should not have persistent diarrhea or other cancers unless in remission for three years.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Abemaciclib alone or combined with Tamoxifen versus standard care in women whose breast cancer has progressed after hormone therapy. The goal is to see if these drugs can help control the disease better.See study design
What are the potential side effects?
Possible side effects include diarrhea (which can be prevented using Loperamide), fatigue, low blood cell counts leading to increased infection risk, liver problems, blood clots, and potential harm to a fetus if pregnancy occurs during treatment.
Next MONARCH 1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is hormone receptor positive and HER2 negative.
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My condition worsened after hormone therapy.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I can take pills by mouth.
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I've had 2 chemotherapy treatments, with 1 or 2 for advanced cancer.
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I stopped my previous cancer treatments at least 3 weeks ago and have recovered from their immediate side effects.
Next MONARCH 1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to death from any cause (approximately 36 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to death from any cause (approximately 36 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Duration of Response (DoR)
+6 moreSide effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib
Next MONARCH 1 Trial Design
3Treatment groups
Experimental Treatment
Group I: Abemaciclib + TamoxifenExperimental Treatment2 Interventions
Abemaciclib given orally every 12 hours (Q12H) in combination with tamoxifen given orally every day. Participants may continue to receive treatment until discontinuation criteria are met.
Group II: Abemaciclib + Prophylactic LoperamideExperimental Treatment2 Interventions
Abemaciclib given orally Q12H in combination with prophylactic loperamide given orally. Participants may continue to receive treatment until discontinuation criteria are met.
Group III: AbemaciclibExperimental Treatment1 Intervention
Abemaciclib given orally Q12H. Participants may continue to receive treatment until discontinuation criteria are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710
Tamoxifen
2005
Completed Phase 4
~29860
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,695 Total Patients Enrolled
64 Trials studying Breast Cancer
36,904 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,018 Total Patients Enrolled
21 Trials studying Breast Cancer
10,608 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I have a history of fainting, irregular heartbeats, or sudden cardiac arrest.I have been cancer-free from other types of cancer, except for nonmelanoma skin cancer or in-situ cervical or breast cancer, for at least 3 years.My breast cancer is hormone receptor positive and HER2 negative.My condition worsened after hormone therapy.I do not have an active infection requiring IV antibiotics or a detectable viral infection.I have been treated with medication targeting CDK4/6 for my cancer.You have a tumor that can be measured using a specific set of guidelines called RECIST 1.1.My cancer has spread to my brain or spinal cord.I have a long-term condition that causes ongoing diarrhea.I am fully active and can carry on all my pre-disease activities without restriction.I can take pills by mouth.I've had 2 chemotherapy treatments, with 1 or 2 for advanced cancer.I stopped my previous cancer treatments at least 3 weeks ago and have recovered from their immediate side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Abemaciclib + Tamoxifen
- Group 2: Abemaciclib
- Group 3: Abemaciclib + Prophylactic Loperamide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many medical institutions are conducting this research experiment?
"This clinical trial is held in 6 different medical establishments, such as Sarah Cannon Cancer Center of Madison, University of Wisconsin-Madison Hospital and Health Clinic in Lebanon, and Dartmouth Hitchcock Medical Centre situated in Fort Worth. Additionally there are three other sites that have been allocated for this study."
Answered by AI
What clinical indications is Abemaciclib traditionally utilized to address?
"Abemaciclib is frequently prescribed to treat estrogen receptors and can be helpful in managing malignant neoplasms, diarrhea, and ovarian cancer."
Answered by AI
Are physicians currently recruiting participants for this experiment?
"Contrary to what clinicaltrials.gov states, this particular medical research is not currently recruiting patients. Initially posted on September 14th 2016 and updated as recently as August 8th 2022, the study has yet to accept any volunteers. However, there are 2455 other studies actively enrolling participants."
Answered by AI
Has Abemaciclib been granted authorization by the Food and Drug Administration?
"Abemaciclib's safety score is a 2, since there has been some data demonstrating its security but none verifying the efficacy of this drug."
Answered by AI
How many participants have been enlisted in this investigation?
"This clinical trial has closed its recruitment, last modified on August 8th 2022. For those seeking alternative options for treatment, 2292 trials are open for breast cancer patients and 163 for Abemaciclib specifically."
Answered by AI
Has Abemaciclib been examined in prior scientific research?
"Presently, 163 trials are underway for Abemaciclib. Of those, 39 live clinical tests have entered Phase 3 of their research. The majority of these investigations take place in Alicante and Pamplona/Iruña; however, a total of 12243 sites offer this treatment study to patients."
Answered by AI
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