← Back to Search

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
Must not have
Have brain metastasis without prior radiotherapy
For Parts F and H: Cardiac disease including myocardial infarction within 6 months, unstable angina, or New York Heart Association (NYHA) Grade II or greater functional impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to study completion (estimated as 12 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety of abemaciclib when used with other treatments for patients whose breast cancer has spread. Abemaciclib helps to stop cancer cells from growing by blocking certain proteins they need. The study aims to find out if this combination is safe for patients with advanced breast cancer.

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.
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.
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 below
Select...
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-.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have cancer that has spread to my brain and haven't had brain radiation.
Select...
I have not had a heart attack or severe heart issues in the last 6 months.
Select...
My breast cancer has spread, is worsening quickly, and is affecting my organs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to study completion (estimated as 12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to study completion (estimated as 12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with One or More Drug-Related Adverse Events
Secondary study objectives
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 more

Side effects data

From 2023 Phase 2 trial • 105 Patients • NCT03321981
47%
Diarrhoea
33%
Fatigue
27%
Vomiting
27%
Asthenia
20%
Decreased appetite
20%
Nausea
20%
Mucosal inflammation
20%
Back pain
13%
Rash
13%
Dry mouth
13%
Dizziness
13%
Arthralgia
13%
Dysuria
13%
Constipation
13%
Neuropathy peripheral
13%
Dry skin
7%
Pain
7%
Spinal pain
7%
Pruritus
7%
Ulcerative keratitis
7%
Inflammation
7%
Blood potassium decreased
7%
Bronchitis
7%
Localised oedema
7%
Axillary pain
7%
Chest pain
7%
Erythema
7%
Conjunctivitis
7%
Muscle spasms
7%
Neck pain
7%
Dysaesthesia
7%
Hypoaesthesia
7%
Vulvovaginal discomfort
7%
Nail infection
7%
Urinary tract infection
7%
Gastrointestinal pain
7%
Vulvovaginal inflammation
7%
Rhinitis
7%
Abdominal pain
7%
Herpes zoster
7%
Weight decreased
7%
Vulvovaginal dryness
7%
Alopecia
7%
Ejection fraction decreased
7%
Depression
7%
Cognitive disorder
7%
Dyspnoea
7%
Oedema peripheral
7%
Peripheral swelling
7%
Burning sensation
7%
Subclavian vein thrombosis
7%
Erysipelas
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 Doublet
Cohort 1 Triplet
Cohort 2

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Everolimus
2010
Completed Phase 4
~1510
Trastuzumab
2014
Completed Phase 4
~5190
Letrozole
2002
Completed Phase 4
~3590
LY2835219
2014
Completed Phase 1
~80
Pertuzumab
2014
Completed Phase 3
~7500
Endocrine therapy
2019
Completed Phase 3
~35530
Loperamide
2010
Completed Phase 4
~2160
Anastrozole
2016
Completed Phase 4
~5550
Tamoxifen
2005
Completed Phase 4
~30110
Exemestane
2003
Completed Phase 4
~7510
LY3023414
2014
Completed Phase 2
~850
Fulvestrant
2011
Completed Phase 3
~3520

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
CDK4/6 inhibitors, such as Abemaciclib, work by blocking the activity of cyclin-dependent kinases 4 and 6, which are crucial for cell cycle progression and cancer cell proliferation. This inhibition helps to halt the growth of cancer cells. Aromatase inhibitors like letrozole and anastrozole reduce estrogen levels by blocking the enzyme aromatase, which converts androgens to estrogens, thereby slowing the growth of hormone receptor-positive breast cancer. Tamoxifen, a selective estrogen receptor modulator, binds to estrogen receptors on cancer cells, preventing estrogen from stimulating cancer growth. Exemestane, another aromatase inhibitor, works similarly by reducing estrogen production. These treatments are vital for breast cancer patients as they target specific pathways involved in cancer cell growth and proliferation, offering more personalized and effective treatment options.
The role of abemaciclib in treatment of advanced breast cancer.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,671 Previous Clinical Trials
3,228,824 Total Patients Enrolled
65 Trials studying Breast Cancer
36,725 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,386 Previous Clinical Trials
426,449 Total Patients Enrolled
22 Trials studying Breast Cancer
10,801 Patients Enrolled for Breast Cancer

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02057133 — Phase 1
Breast Cancer Research Study Groups: LY2835219 + Exemestane + Everolimus Dose Expansion, LY2835219 + Anastrozole, LY2835219 + Exemestane, LY3023414 + LY2835219 + Fulvestrant Dose Expansion, LY2835219+ Trastuzumab Dose Escalation, LY2835219 + Exemestane + Everolimus Dose Escalation, LY2835219 + Letrozole, LY3023414 + LY2835219 + Fulvestrant Dose Escalation, LY2835219 +Trastuzumab + Pertuzumab +Loperamide Dose Expansion, LY2835219 + Tamoxifen, LY2835219 +Trastuzumab +Pertuzumab +Loperamide Dose Escalation, LY2835219+ Trastuzumab Dose Expansion, LY2835219 + Endocrine Therapy
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT02057133 — Phase 1
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02057133 — Phase 1
~17 spots leftby Nov 2025