Breast NeoplasmsPhase 4NCT04707196
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
A Phase 4 study testing Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI) and Fulvestrant in people with Breast Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 15 sites in India.
Trial summary
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis
- What is being tested?
- Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI) and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 15 sitesIndia
- Study dates
- 22 Feb 2021to 9 Jan 2023
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
- Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
- Have postmenopausal status
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have adequate organ function
- Have discontinued previous cytotoxic therapies, biological agents, investigational agents, and radiotherapy
- Are able to swallow oral formulation
Who cannot join
- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
- 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 cyclin-dependent kinase (CDK) 4 \& 6 inhibitor.
- Have received recent (within 28 days prior to study intervention) live vaccination (for example, yellow fever). Seasonal flu vaccinations that do not contain a live virus are permitted.
- Have a personal history of presyncope or syncope of either unexplained or 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.
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- Have received an autologous or allogeneic stem-cell transplant
- Have clinically relevant active bacterial or fungal infection, or detectable viral infection (for example, human immunodeficiency virus or viral hepatitis). Screening is not required for enrolment.
- Are pregnant or breastfeeding.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
India15 sites
HCG Cancer Centre, Kalinga Rao Road
Bengaluru, Karnataka, 560020
Max Superspeciality Hospital
Chandigarh, 160055
MNJ Institute of Oncology
Hyderabad, Andhra Pradesh, 500004
SRJ-CBCC Cancer Hospital
Indore, Madhya Pradesh, 452001
Apollo Gleneagles Hospitals Kolkata
Kolkata, West Bengal, 700054
Kingsway Hospital
Nagpur, Maharashtra, 440001
Meditrina Institute of Medical Sciences
Nagpur, Maharashtra, 440012
HCG Manavata Cancer Centre
Nashik, Maharashtra, 422001
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, 110085
Indira Gandhi Institute of Medical Sciences
Patna, Bihar, 800014
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, 411001
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, 395002
Unique Hospital Multispecialty & Research Institute
Surat, Gujarat, 395002
Regional Cancer Centre
Trivandrum, Kerala, 695011
Kailash Cancer Hospital & Research Centre (KCHRC)
Waghodia, Gujarat, 391760
About this study
Official title: A Single-Arm, Phase 4 Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, in Combination With Endocrine Therapy (Anastrozole/Letrozole or Fulvestrant) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced and/or Metastatic Breast Cancer in India
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer. Participants must have hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer and must live in India. For each participant, the study could last up to eight months and may include up to eight visits to the study center.
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Being tested
- Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI), Fulvestrant
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
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
Nonsteroidal Aromatase Inhibitor (NSAI)Drug
Letrozole or anastrozole administered orally (physician choice)
FulvestrantDrug
Administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Abemaciclib + NSAI or Fulvestrant | Experimental | Participants received abemaciclib 150 milligram (mg) orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus either NSAI (nonsteroidal aromatase inhibitors - anastrozole or letrozole) administered orally as per standard of care or fulvestrant administered intramuscularly as per standard of care. Receives: Drug: Abemaciclib; Drug: Nonsteroidal Aromatase Inhibitor (NSAI); Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that started at the time of, or after the, first study medication administration as well as those events that started prior to the first study drug administration, but which worsened after the first study medication administration. The reported data reflects the unique percentage of participants who experienced any serious and other non-serious adverse events. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline until end of follow-up (Up To 7 Months)
Secondary outcomes (1)
Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Baseline until end of study treatment (Up To 6 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start22 Feb 2021
- Primary completion9 Jan 2023
- Study completion9 Jan 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 Breast NeoplasmsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT04707196
- Sponsor's protocol ID
- 17782
- Other IDs
- I3Y-IN-JPEC
- Status last verified
- Nov 2023
- First submitted
- 12 Jan 2021
- Last updated
- 24 Nov 2023
- 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Phase 4 Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, in Combination With Endocrine Therapy (Anastrozole/Letrozole or Fulvestrant) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced and/or Metastatic Breast Cancer in India
- ClinicalTrials.gov ID
- NCT04707196
- Acronym / sponsor ID
- 17782
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Posted 21 Nov 2023
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 learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer. Participants must have hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer and must live in India. For each participant, the study could last up to eight months and may include up to eight visits to the study center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abemaciclib + NSAI or Fulvestrant | Experimental | Drug: Abemaciclib, Drug: Nonsteroidal Aromatase Inhibitor (NSAI), Drug: FulvestrantParticipants received abemaciclib 150 milligram (mg) orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus either NSAI (nonsteroidal aromatase inhibitors - anastrozole or letrozole) administered orally as per standard of care or fulvestrant administered intramuscularly as per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
- Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
- Have postmenopausal status
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have adequate organ function
Key exclusion criteria (9 listed)
- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
- 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 cyclin-dependent kinase (CDK) 4 \& 6 inhibitor.
- Have received recent (within 28 days prior to study intervention) live vaccination (for example, yellow fever). Seasonal flu vaccinations that do not contain a live virus are permitted.
- Have a personal history of presyncope or 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 | Abemaciclib + NSAI or Fulvestrant |
| Nonsteroidal Aromatase Inhibitor (NSAI)Letrozole or anastrozole administered orally (physician choice) | Drug | Abemaciclib + NSAI or Fulvestrant |
| FulvestrantAdministered intramuscularly | Drug | Abemaciclib + NSAI or Fulvestrant |
Primary outcome
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event
Time frame: Baseline until end of follow-up (Up To 7 Months)
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that started at the time of, or after the, first study medication administration as well as those events that started prior to the first study drug administration, but which worsened after the first study medication administration. The reported data reflects the unique percentage of participants who experienced any serious and other non-serious adverse events. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
1 secondary outcome
Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events
Time frame: Baseline until end of study treatment (Up To 6 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI) and Fulvestrant in people with Breast Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 15 sites in India.
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 7 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 24 Nov 2023. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 21 Nov 2023). 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 Experiencing at Least One Treatment-Emergent Adverse Event (time frame: Baseline until end of follow-up (Up To 7 Months)). 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 24 Nov 2023.