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CDK4/6 Inhibitor
Abemaciclib Combination Therapy for Advanced Breast Cancer
Phase 1
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
For Part I (abemaciclib + endocrine therapy): The participant must have demonstrated evidence of disease progression on a Cyclin Dependent Kinase 4 (CDK4) and Cyclin Dependent Kinase 6 (CDK6) inhibitor (either palbociclib or ribociclib) plus endocrine therapy for advanced or metastatic disease as the most recent therapy immediately preceding study entry. The participant should remain on the current endocrine therapy while receiving abemaciclib
For Part A (LY2835219 + letrozole): Except for ongoing therapy with letrozole, the participant must not have received prior systemic endocrine therapy for metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to study completion (estimated as 12 months)
Awards & highlights
Study Summary
This trial looks at the safety of using abemaciclib in different combinations of drugs to treat breast cancer that has spread.
Who is the study for?
This trial is for adults with breast cancer that has spread, who have specific treatment histories and organ function. Participants must not have severe preexisting conditions or certain heart diseases, and should not have received some treatments like CDK4/6 inhibitors (except in Part I) or systemic chemotherapy for metastatic disease.Check my eligibility
What is being tested?
The study tests the safety of abemaciclib combined with various therapies (like letrozole, anastrozole, tamoxifen) for advanced breast cancer. It examines how well these combinations work when the cancer has spread to other body parts.See study design
What are the potential side effects?
Potential side effects may include digestive issues, fatigue, blood disorders, liver problems, risk of infection due to immune system suppression. Specific side effects depend on the combination therapy used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer progressed despite treatment with CDK4/6 inhibitors and hormone therapy.
Select...
I have not had hormone therapy for my cancer, except for letrozole.
Select...
I am willing to have tumor biopsies before and after the study treatment.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I stopped all breast cancer treatments 21 days ago, except for hair loss or nerve issues.
Select...
My blood, liver, and kidney functions are all within normal ranges.
Select...
I am post-menopausal or pre-menopausal using ovarian suppression treatment.
Select...
My breast cancer is HR+ and HER2-.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to study completion (estimated as 12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to study completion (estimated as 12 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with One or More Drug-Related Adverse Events
Secondary outcome measures
Change in MD Anderson Symptom Inventory (MDASI) Score from Baseline
Number of Participants with a Complete or Partial Tumor Response (Overall Response Rate)
Pharmacokinetics: Area under the Curve (AUC) of LY2835219, Letrozole, Anastrozole, Tamoxifen, Exemestane, Everolimus, Trastuzumab, LY3023414, Fulvestrant, and Pertuzumab
+2 moreSide effects data
From 2023 Phase 2 trial • 105 Patients • NCT0332198172%
Diarrhoea
46%
Asthenia
46%
Nausea
44%
Neutropenia
33%
Fatigue
31%
Constipation
28%
Anaemia
23%
Abdominal pain
18%
Neutrophil count decreased
18%
Weight decreased
18%
Cough
18%
Headache
15%
Neuropathy peripheral
15%
Urinary tract infection
15%
Dyspnoea
15%
Vomiting
15%
Muscle spasms
15%
Decreased appetite
13%
Pyrexia
13%
Alopecia
13%
Myalgia
10%
Chest pain
10%
Dysgeusia
10%
Blood potassium decreased
10%
Stomatitis
8%
Back pain
8%
Pruritus
8%
Mucosal inflammation
8%
Oedema peripheral
8%
Ejection fraction decreased
8%
Depression
5%
Urinary incontinence
5%
Thrombocytopenia
5%
Arthralgia
5%
Paraesthesia
5%
Gastrooesophageal reflux disease
5%
Aspartate aminotransferase increased
5%
Platelet count decreased
5%
Pain in jaw
5%
Peripheral motor neuropathy
5%
Pain in extremity
5%
Dizziness
5%
Epistaxis
5%
Hot flush
5%
Pain
5%
Dry eye
5%
Gastrointestinal pain
5%
Tinnitus
5%
Non-cardiac chest pain
5%
Nasopharyngitis
5%
Chills
5%
Dysphagia
5%
Paronychia
5%
Influenza
5%
Peripheral sensory neuropathy
5%
Insomnia
5%
Neuralgia
3%
Skin ulcer
3%
Hypotension
3%
Anxiety
3%
Pharyngitis
3%
Hypersensitivity
3%
Body temperature increased
3%
Muscular weakness
3%
Mobility decreased
3%
Restless legs syndrome
3%
Breast pain
3%
Rhinorrhoea
3%
Hypoaesthesia oral
3%
Malabsorption
3%
Abscess limb
3%
Haemorrhoids
3%
Lung infection
3%
Dehydration
3%
Procedural dizziness
3%
Erythema
3%
Stress urinary incontinence
3%
Eye allergy
3%
Foot fracture
3%
Colitis
3%
Aphasia
3%
Rash maculo-papular
3%
Upper respiratory tract infection
3%
Alanine aminotransferase increased
3%
Nervous system disorder
3%
Skin fissures
3%
Sepsis
3%
Infusion related reaction
3%
Leukopenia
3%
Vertigo
3%
Aphthous ulcer
3%
Skin infection
3%
Abdominal distension
3%
Hyperthermia
3%
Nasal congestion
3%
Mastitis fungal
3%
Blood sodium decreased
3%
Humerus fracture
3%
Blood phosphorus decreased
3%
Iron deficiency
3%
Vocal cord paralysis
3%
Nail disorder
3%
Stress
3%
Breast inflammation
3%
Rash
3%
Nail discolouration
3%
Orthostatic hypotension
3%
Seizure
3%
Visual acuity reduced
3%
Chalazion
3%
Tachycardia
3%
Eyelid sensory disorder
3%
Blepharitis
3%
Ulcerative keratitis
3%
Febrile neutropenia
3%
Osteomyelitis
3%
Photophobia
3%
Gastritis
3%
Erysipelas
3%
Gait disturbance
3%
Oral fungal infection
3%
Abdominal pain upper
3%
Sinusitis
3%
Oesophageal pain
3%
Toothache
3%
Blood calcium decreased
3%
Rectal haemorrhage
3%
Sciatica
3%
Somnolence
3%
Localised oedema
3%
Oral candidiasis
3%
Rash pustular
3%
Amnesia
3%
Enthesopathy
3%
Onycholysis
3%
Haemoptysis
3%
Telangiectasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 Triplet
Cohort 1 Doublet
Cohort 2
Trial Design
13Treatment groups
Experimental Treatment
Group I: LY3023414 + LY2835219 + Fulvestrant Dose ExpansionExperimental Treatment3 Interventions
LY3023414 administered orally. LY2835219 administered orally. Fulvestrant administered IM.
Group II: LY3023414 + LY2835219 + Fulvestrant Dose EscalationExperimental Treatment3 Interventions
LY3023414 administered orally. LY2835219 administered orally. Fulvestrant administered intramuscularly (IM).
Group III: LY2835219+ Trastuzumab Dose ExpansionExperimental Treatment2 Interventions
LY2835219 administered orally. Trastuzumab administered IV infusion. This arm is closed to enrollment.
Group IV: LY2835219+ Trastuzumab Dose EscalationExperimental Treatment2 Interventions
LY2835219 administered orally. Trastuzumab administered intravenously (IV) infusion. This arm is closed to enrollment.
Group V: LY2835219 +Trastuzumab +Pertuzumab +Loperamide Dose EscalationExperimental Treatment4 Interventions
LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion.
Group VI: LY2835219 +Trastuzumab + Pertuzumab +Loperamide Dose ExpansionExperimental Treatment5 Interventions
Hormone Receptor Negative (HR-): LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion.
Hormone Receptor Positive (HR+): LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion. Endocrine therapy administered orally.
Group VII: LY2835219 + TamoxifenExperimental Treatment2 Interventions
LY2835219 administered orally. Tamoxifen administered orally. This arm is closed to enrollment.
Group VIII: LY2835219 + LetrozoleExperimental Treatment2 Interventions
LY2835219 administered orally. Letrozole administered orally. This arm is closed to enrollment.
Group IX: LY2835219 + Exemestane + Everolimus Dose ExpansionExperimental Treatment3 Interventions
LY2835219 administered orally. Exemestane administered orally. Everolimus administered orally. This arm is closed to enrollment.
Group X: LY2835219 + Exemestane + Everolimus Dose EscalationExperimental Treatment3 Interventions
LY2835219 administered orally. Exemestane administered orally. Everolimus administered orally. This arm is closed to enrollment.
Group XI: LY2835219 + ExemestaneExperimental Treatment2 Interventions
LY2835219 administered orally. Exemestane administered orally. This arm is closed to enrollment.
Group XII: LY2835219 + Endocrine TherapyExperimental Treatment2 Interventions
LY2835219 administered orally. Ongoing endocrine therapy administered orally.
Group XIII: LY2835219 + AnastrozoleExperimental Treatment2 Interventions
LY2835219 administered orally. Anastrozole administered orally. This arm is closed to enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY2835219
2009
Completed Phase 1
~300
Exemestane
2003
Completed Phase 4
~7880
Tamoxifen
2005
Completed Phase 4
~29860
Anastrozole
2019
Completed Phase 4
~10090
LY3023414
2014
Completed Phase 2
~850
Fulvestrant
2011
Completed Phase 3
~3690
Pertuzumab
2014
Completed Phase 3
~7500
Loperamide
2010
Completed Phase 4
~2160
Trastuzumab
2014
Completed Phase 4
~5190
Everolimus
2010
Completed Phase 4
~1510
Endocrine therapy
2019
Completed Phase 3
~35460
Letrozole
2002
Completed Phase 4
~3240
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,731 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
405,054 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:- I have been treated with a nonsteroidal aromatase inhibitor for my metastatic disease and may currently be on exemestane.My cancer progressed despite treatment with CDK4/6 inhibitors and hormone therapy.I have brain metastases treated with radiotherapy or had neurological changes within the last 14 days.Your recent heart test showed certain abnormal results like irregular heartbeats, signs of heart problems, or a prolonged QT interval.I have cancer that has spread to my brain and haven't had brain radiation.I have not had a heart attack or severe heart issues in the last 6 months.I have type 1 diabetes, had gestational diabetes, or my type 2 diabetes is well-controlled with pills.My breast cancer is HER2 positive and has spread to other parts.I have not had hormone therapy for my cancer, except for letrozole.I have not had hormone therapy for my metastatic disease, except for anastrozole.I have been treated with a nonsteroidal aromatase inhibitor for my metastatic disease.I am fully active and can carry on all pre-disease activities without restriction.I am willing to have tumor biopsies before and after the study treatment.I stopped all breast cancer treatments 21 days ago, except for hair loss or nerve issues.I have been treated with a nonsteroidal aromatase inhibitor for my cancer and may currently be on exemestane or exemestane + everolimus.For parts G, H, and I, you have a disease that can be measured using a specific set of guidelines.I've had chemotherapy for metastatic disease and my heart function is normal.I've had chemotherapy for my metastatic disease and my heart function is normal.My cancer can be measured or evaluated, especially in the bones.My blood, liver, and kidney functions are all within normal ranges.My breast cancer has spread, is worsening quickly, and is affecting my organs.You have received certain types of medication before, depending on the part of the study.I am post-menopausal or pre-menopausal using ovarian suppression treatment.I may have had hormone therapy for my cancer and could be on tamoxifen now.My breast cancer is HR+ and HER2-.I have had chemotherapy for cancer that has spread, but may also have had it as part of initial treatment.
Research Study Groups:
This trial has the following groups:- Group 1: LY2835219 + Exemestane + Everolimus Dose Expansion
- Group 2: LY2835219 + Anastrozole
- Group 3: LY2835219 + Exemestane
- Group 4: LY3023414 + LY2835219 + Fulvestrant Dose Expansion
- Group 5: LY2835219+ Trastuzumab Dose Escalation
- Group 6: LY2835219 + Exemestane + Everolimus Dose Escalation
- Group 7: LY2835219 + Letrozole
- Group 8: LY3023414 + LY2835219 + Fulvestrant Dose Escalation
- Group 9: LY2835219 +Trastuzumab + Pertuzumab +Loperamide Dose Expansion
- Group 10: LY2835219 + Tamoxifen
- Group 11: LY2835219 +Trastuzumab +Pertuzumab +Loperamide Dose Escalation
- Group 12: LY2835219+ Trastuzumab Dose Expansion
- Group 13: LY2835219 + Endocrine Therapy
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.
What medical conditions are Endocrine therapies most often prescribed for?
"Endocrine therapy, which is used to target estrogen receptors, has the potential to combat a range of illnesses such as disease progression, diarrhea, and pulmonary issues."
Answered by AI
Are there vacancies currently available for participants of this research?
"At present, this trial is not open for enrollment. The study was first made available on March 10th 2014 and last updated August 8th 2022; however, if you are looking for other clinical trials there are 2287 studies focusing on breast cancer that are still accepting patients and 613 endocrine therapy related experiments."
Answered by AI
Have any prior experiments been conducted related to Endocrine treatment?
"Endocrine therapy was initially examined in 1994 at Queen Mary University of London. Since then, a total of 1272 trials have been finished, and 613 are presently active - notably there is a high concentration of research conducted out of Nashville, Tennessee."
Answered by AI
At which locations is this research experiment being conducted?
"Patients in need of this medical intervention can be enrolled at Tennessee Oncology PLLC, Providence Cancer Center Oncology Hematology Care and University of North carolina at Chapel Hill. Additionally, there are 16 other enrolment sites across the United States."
Answered by AI
Has Endocrine therapy received authorization from the FDA yet?
"We gave endocrine therapy a score of 1 on our scale, indicating that while it has been trialled before, there is limited evidence to support its efficacy and safety."
Answered by AI
To what extent is this experiment being conducted with participants?
"At this time, no patients are being enrolled in the trial. The study was initially released on March 10th 2014 and has since been updated as recently as August 8th 2022. However, if you wish to explore alternative options for participation there are currently 2287 studies actively seeking out individuals with breast cancer and 613 endocrine therapy trials looking for participants."
Answered by AI
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