A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
NCT ID: NCT04707196
Last Updated: 2023-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2021-02-22
2023-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Abemaciclib + NSAI or Fulvestrant
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.
Abemaciclib
Administered orally
Nonsteroidal Aromatase Inhibitor (NSAI)
Letrozole or anastrozole administered orally (physician choice)
Fulvestrant
Administered intramuscularly
Interventions
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Abemaciclib
Administered orally
Nonsteroidal Aromatase Inhibitor (NSAI)
Letrozole or anastrozole administered orally (physician choice)
Fulvestrant
Administered intramuscularly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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MNJ Institute of Oncology
Hyderabad, Andhra Pradesh, India
Indira Gandhi Institute of Medical Sciences
Patna, Bihar, India
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, India
Unique Hospital Multispecialty & Research Institute
Surat, Gujarat, India
Kailash Cancer Hospital & Research Centre (KCHRC)
Waghodia, Gujarat, India
HCG Cancer Centre, Kalinga Rao Road
Bengaluru, Karnataka, India
Regional Cancer Centre
Trivandrum, Kerala, India
SRJ-CBCC Cancer Hospital
Indore, Madhya Pradesh, India
Kingsway Hospital
Nagpur, Maharashtra, India
Meditrina Institute of Medical Sciences
Nagpur, Maharashtra, India
HCG Manavata Cancer Centre
Nashik, Maharashtra, India
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, India
Apollo Gleneagles Hospitals Kolkata
Kolkata, West Bengal, India
Max Superspeciality Hospital
Chandigarh, , India
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I3Y-IN-JPEC
Identifier Type: OTHER
Identifier Source: secondary_id
17782
Identifier Type: -
Identifier Source: org_study_id