Status:
COMPLETED
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Breast Neoplasms
Neoplasm Metastasis
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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. Participant...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04707196
Start Date
February 22 2021
End Date
January 9 2023
Last Update
November 24 2023
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
MNJ Institute of Oncology
Hyderabad, Andhra Pradesh, India, 500004
2
Indira Gandhi Institute of Medical Sciences
Patna, Bihar, India, 800014
3
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, India, 395002
4
Unique Hospital Multispecialty & Research Institute
Surat, Gujarat, India, 395002