A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
Primary Purpose
Breast Neoplasms, Neoplasm Metastasis
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Abemaciclib
Nonsteroidal Aromatase Inhibitor (NSAI)
Fulvestrant
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- MNJ Institute of Oncology
- Indira Gandhi Institute of Medical Sciences
- Rajiv Gandhi Cancer Institute And Research Centre
- Nirmal Hospital Pvt Ltd.
- Unique Hospital Multispecialty & Research Institute
- Kailash Cancer Hospital & Research Centre (KCHRC)
- HCG Cancer Centre, Kalinga Rao Road
- Regional Cancer Centre
- SRJ-CBCC Cancer Hospital
- Kingsway Hospital
- Meditrina Institute of Medical Sciences
- HCG Manavata Cancer Centre
- Ruby Hall Clinic and Grant Medical Foundation
- Apollo Gleneagles Hospitals Kolkata
- Max Superspeciality Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Abemaciclib + NSAI or Fulvestrant
Arm Description
Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally or Fulvestrant administered intramuscularly.
Outcomes
Primary Outcome Measures
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
Secondary Outcome Measures
Percentage of Participants who Discontinue from Study Treatment Due to Adverse Events
Percentage of Participants who Discontinue from Study Treatment Due to Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04707196
Brief Title
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
January 9, 2023 (Actual)
Study Completion Date
January 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Neoplasm Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abemaciclib + NSAI or Fulvestrant
Arm Type
Experimental
Arm Description
Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally or Fulvestrant administered intramuscularly.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Other Intervention Name(s)
LY2835219
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Nonsteroidal Aromatase Inhibitor (NSAI)
Intervention Description
Letrozole administered orally or anastrozole administered orally (physician choice)
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
Administered intramuscularly
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
Description
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
Time Frame
Baseline through Month 6
Secondary Outcome Measure Information:
Title
Percentage of Participants who Discontinue from Study Treatment Due to Adverse Events
Description
Percentage of Participants who Discontinue from Study Treatment Due to Adverse Events
Time Frame
Baseline through Month 6
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
MNJ Institute of Oncology
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500004
Country
India
Facility Name
Indira Gandhi Institute of Medical Sciences
City
Patna
State/Province
Bihar
ZIP/Postal Code
800014
Country
India
Facility Name
Rajiv Gandhi Cancer Institute And Research Centre
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Nirmal Hospital Pvt Ltd.
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Unique Hospital Multispecialty & Research Institute
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Kailash Cancer Hospital & Research Centre (KCHRC)
City
Waghodia
State/Province
Gujarat
ZIP/Postal Code
391760
Country
India
Facility Name
HCG Cancer Centre, Kalinga Rao Road
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560020
Country
India
Facility Name
Regional Cancer Centre
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
SRJ-CBCC Cancer Hospital
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452001
Country
India
Facility Name
Kingsway Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440001
Country
India
Facility Name
Meditrina Institute of Medical Sciences
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
HCG Manavata Cancer Centre
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422001
Country
India
Facility Name
Ruby Hall Clinic and Grant Medical Foundation
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Apollo Gleneagles Hospitals Kolkata
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Max Superspeciality Hospital
City
Chandigarh
ZIP/Postal Code
160055
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Learn more about this trial
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
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