Metastatic Breast CancerPhase 2NCT03703466
A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
A Phase 2 study testing Abemaciclib in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 15 sites in 5 countries.
Trial summary
The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Abemaciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 28 Nov 2018to 9 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).
- Have all of the following:
- Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
- Prior treatment with chemotherapy for locally advanced or metastatic disease.
- No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
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- Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
- Have adequate organ function.
- Women of child-bearing potential must have a negative pregnancy test.
- Are able to swallow tablets/capsules.
Who cannot join
- Are currently receiving treatment in a clinical study involving an investigational product.
- Have a serious concomitant systemic disorder.
- Have symptomatic central nervous system (CNS) malignancy or metastasis.
- Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
- Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
- Have a history of any other cancer.
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- Had major surgery within 14 days prior to randomization.
- Are breastfeeding.
- Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Australia4 sites
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Mater Private Hospital
North Sydney, New South Wales, 2291
St Vincent's Hospital
Sydney, New South Wales, 2010
Spain4 sites
Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga
Barcelona, 08023
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Ruber Internacional
Madrid, 28034
Hospital Clinico San Carlos
Madrid, 28040
Turkey (Türkiye)4 sites
Akdeniz University Medical Faculty
Antalya, 07058
Trakya University Faculty of Medicine
Edirne, 22030
Medical Park Izmir Hospital
Izmir, 35575
Inonu University Medical Faculty
Malatya, 44280
Russia2 sites
Russian Oncological Research Center
Moscow, 115478
Volgograd regional clinical oncology dispensary
Volgograd, 400138
Belgium1 site
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000
About this study
Official title: An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability When Receiving Abemaciclib for Patients With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Abemaciclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Also called LY2835219
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 200 mg Abemaciclib With a Meal | Experimental | 200 mg abemaciclib given twice a day (BID) orally with a meal. Receives: Drug: Abemaciclib |
| 200 mg Abemaciclib Without a Meal | Experimental | 200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition. Receives: Drug: Abemaciclib |
| 200 mg Abemaciclib Without Regard to Food | Experimental | 200 mg abemaciclib given twice a day (BID) orally without regard for food. Receives: Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Severe Diarrhea (≥ Grade 3)
Percentage of participants with severe diarrhea (≥ grade 3) during the first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 was defined as an increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living (ADL).
Measured: Cycle 3 (28 Days Cycle)
Percentage of Participants With Prolonged Grade 2 Diarrhea
Percentage of participants with prolonged grade 2 diarrhea during first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Prolonged Grade 2 diarrhea was any event lasting more than 7 days. Grade 2 was defined as Increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline.
Measured: Cycle 3 (28 Days Cycle)
Percentage of Participants With Dose Reductions Due to Diarrhea
Percentage of participants with dose reductions due to diarrhea during first 3 cycles.
Measured: Cycle 3 (28 Days Cycle)
Percentage of Participants With Dose Interruptions Due to Diarrhea
Percentage of participants with dose interruptions due to diarrhea during first 3 cycles.
Measured: Cycle 3 (28 Days Cycle)
Percentage of Participants Who Discontinue Treatment Due to Diarrhea
Percentage of participants who discontinue treatment due to diarrhea
Measured: Cycle 3 (28 Days Cycle)
Percentage of Participants Utilizing Antidiarrheals
Percentage of participants who utilized anti diarrheals at least once during the first 3 cycles.
Measured: Cycle 3 (28 Days Cycle)
Secondary outcomes (3)
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
PK: Mean steady state exposure of abemaciclib
Measured: Cycle 1: Day 15; Cycle 2: Day 1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
PK: Mean steady state exposure of abemaciclib metabolite LSN2839567
Measured: Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
PK: Mean steady state exposure of abemaciclib metabolite LSN3106726
Measured: Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start28 Nov 2018
- Primary completion29 Jul 2019
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703466
- Sponsor's protocol ID
- 17041
- Other IDs
- I3Y-MC-JPCP, 2018-001853-28, 2018
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2018
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability When Receiving Abemaciclib for Patients With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03703466
- Acronym / sponsor ID
- 17041
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Posted 13 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200 mg Abemaciclib With a Meal | Experimental | Drug: Abemaciclib200 mg abemaciclib given twice a day (BID) orally with a meal. |
| 200 mg Abemaciclib Without a Meal | Experimental | Drug: Abemaciclib200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition. |
| 200 mg Abemaciclib Without Regard to Food | Experimental | Drug: Abemaciclib200 mg abemaciclib given twice a day (BID) orally without regard for food. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).
- Have all of the following:
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
- Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
- Have adequate organ function.
Key exclusion criteria (9 listed)
- Are currently receiving treatment in a clinical study involving an investigational product.
- Have a serious concomitant systemic disorder.
- Have symptomatic central nervous system (CNS) malignancy or metastasis.
- Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
- Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbemaciclibAlso: LY2835219Administered orally. | Drug | 200 mg Abemaciclib With a Meal, 200 mg Abemaciclib Without Regard to Food, 200 mg Abemaciclib Without a Meal |
Primary outcome
Percentage of Participants With Severe Diarrhea (≥ Grade 3)
Time frame: Cycle 3 (28 Days Cycle)
Percentage of participants with severe diarrhea (≥ grade 3) during the first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 was defined as an increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living (ADL).
Percentage of Participants With Prolonged Grade 2 Diarrhea
Time frame: Cycle 3 (28 Days Cycle)
Percentage of participants with prolonged grade 2 diarrhea during first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Prolonged Grade 2 diarrhea was any event lasting more than 7 days. Grade 2 was defined as Increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline.
Percentage of Participants With Dose Reductions Due to Diarrhea
Time frame: Cycle 3 (28 Days Cycle)
Percentage of participants with dose reductions due to diarrhea during first 3 cycles.
Percentage of Participants With Dose Interruptions Due to Diarrhea
Time frame: Cycle 3 (28 Days Cycle)
Percentage of participants with dose interruptions due to diarrhea during first 3 cycles.
Percentage of Participants Who Discontinue Treatment Due to Diarrhea
Time frame: Cycle 3 (28 Days Cycle)
Percentage of participants who discontinue treatment due to diarrhea
Percentage of Participants Utilizing Antidiarrheals
Time frame: Cycle 3 (28 Days Cycle)
Percentage of participants who utilized anti diarrheals at least once during the first 3 cycles.
3 secondary outcomes
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Time frame: Cycle 1: Day 15; Cycle 2: Day 1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Time frame: Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Time frame: Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast CancerLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Australia, Spain, Turkey (Türkiye), Russia, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Severe Diarrhea (≥ Grade 3) (time frame: Cycle 3 (28 Days Cycle)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.