A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Abemaciclib + NSAI or Fulvestrant Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally or Fulvestrant administered intramuscularly. |
Drug: Abemaciclib
Administered orally
Other Names:
Drug: Nonsteroidal Aromatase Inhibitor (NSAI)
Letrozole administered orally or anastrozole administered orally (physician choice)
Drug: Fulvestrant
Administered intramuscularly
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) [Baseline through Month 6]
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 [Baseline through Month 6]
Percentage of Participants who Discontinue from Study Treatment Due to Adverse Events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
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Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
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Have postmenopausal status
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Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
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Have adequate organ function
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Have discontinued previous cytotoxic therapies, biological agents, investigational agents, and radiotherapy
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Are able to swallow oral formulation
Exclusion Criteria:
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Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
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Have clinical evidence or history of central nervous system metastasis.
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Have received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, everolimus, or any cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
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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.
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Have a personal history of presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
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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
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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.
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Are pregnant or breastfeeding.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | MNJ Institute of Oncology | Hyderabad | Andhra Pradesh | India | 500004 |
2 | Indira Gandhi Institute of Medical Sciences | Patna | Bihar | India | 800014 |
3 | Rajiv Gandhi Cancer Institute And Research Centre | New Delhi | Delhi | India | 110085 |
4 | Nirmal Hospital Pvt Ltd. | Surat | Gujarat | India | 395002 |
5 | Unique Hospital Multispecialty & Research Institute | Surat | Gujarat | India | 395002 |
6 | Anand Multispeciality Hospital | Vadodara | Gujarat | India | 390016 |
7 | Kailash Cancer Hospital & Research Centre (KCHRC) | Waghodia | Gujarat | India | 391760 |
8 | HCG Cancer Centre, Kalinga Rao Road | Bengaluru | Karnataka | India | 560020 |
9 | Regional Cancer Centre | Trivandrum | Kerala | India | 695011 |
10 | SRJ-CBCC Cancer Hospital | Indore | Madhya Pradesh | India | 452001 |
11 | Kingsway Hospital | Nagpur | Maharashtra | India | 440001 |
12 | Meditrina Institute of Medical Sciences | Nagpur | Maharashtra | India | 440012 |
13 | HCG Manavata Cancer Centre | Nashik | Maharashtra | India | 422001 |
14 | Ruby Hall Clinic and Grant Medical Foundation | Pune | Maharashtra | India | 411001 |
15 | Apollo Gleneagles Hospitals Kolkata | Kolkata | West Bengal | India | 700054 |
16 | Max Superspeciality Hospital | Chandigarh | India | 160055 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17782
- I3Y-IN-JPEC