A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
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
2 other identifiers
interventional
200
1 country
15
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2021
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedStudy Start
First participant enrolled
February 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2023
CompletedResults Posted
Study results publicly available
November 21, 2023
CompletedNovember 24, 2023
November 1, 2023
1.9 years
January 12, 2021
October 31, 2023
November 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
Baseline until end of study treatment (Up To 6 Months)
Study Arms (1)
Abemaciclib + NSAI or Fulvestrant
EXPERIMENTALParticipants 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.
Interventions
Letrozole or anastrozole administered orally (physician choice)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
MNJ Institute of Oncology
Hyderabad, Andhra Pradesh, 500004, India
Indira Gandhi Institute of Medical Sciences
Patna, Bihar, 800014, India
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, 395002, India
Unique Hospital Multispecialty & Research Institute
Surat, Gujarat, 395002, India
Kailash Cancer Hospital & Research Centre (KCHRC)
Waghodia, Gujarat, 391760, India
HCG Cancer Centre, Kalinga Rao Road
Bengaluru, Karnataka, 560020, India
Regional Cancer Centre
Trivandrum, Kerala, 695011, India
SRJ-CBCC Cancer Hospital
Indore, Madhya Pradesh, 452001, India
Kingsway Hospital
Nagpur, Maharashtra, 440001, India
Meditrina Institute of Medical Sciences
Nagpur, Maharashtra, 440012, India
HCG Manavata Cancer Centre
Nashik, Maharashtra, 422001, India
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, 411001, India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, 110085, India
Apollo Gleneagles Hospitals Kolkata
Kolkata, West Bengal, 700054, India
Max Superspeciality Hospital
Chandigarh, 160055, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 13, 2021
Study Start
February 22, 2021
Primary Completion
January 9, 2023
Study Completion
January 9, 2023
Last Updated
November 24, 2023
Results First Posted
November 21, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.