A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

Phase 4

Completed

Interventions: Drug: Abemaciclib
Drug: Nonsteroidal Aromatase Inhibitor (NSAI)
Drug: Fulvestrant

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Abemaciclib + NSAI or Fulvestrant	Nonsteroidal Aromatase Inhibitor (NSAI)	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 + NSAI or Fulvestrant	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 + NSAI or Fulvestrant	Abemaciclib	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event	Baseline until end of follow-up (Up To 7 Months)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events	Baseline until end of study treatment (Up To 6 Months)	An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Locations (15): Nirmal Hospital Pvt Ltd.
🇮🇳
Surat, Gujarat, India
Meditrina Institute of Medical Sciences
🇮🇳
Nagpur, Maharashtra, India
Rajiv Gandhi Cancer Institute And Research Centre
🇮🇳
New Delhi, Delhi, India
Unique Hospital Multispecialty & Research Institute
🇮🇳
Surat, Gujarat, India
SRJ-CBCC Cancer Hospital
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Indore, Madhya Pradesh, India
HCG Manavata Cancer Centre
🇮🇳
Nashik, Maharashtra, India
Max Superspeciality Hospital
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Chandigarh, India
Ruby Hall Clinic and Grant Medical Foundation
🇮🇳
Pune, Maharashtra, India
Apollo Gleneagles Hospitals Kolkata
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Kolkata, West Bengal, India
HCG Cancer Centre, Kalinga Rao Road
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Bengaluru, Karnataka, India
Regional Cancer Centre
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Trivandrum, Kerala, India
Indira Gandhi Institute of Medical Sciences
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Patna, Bihar, India
MNJ Institute of Oncology
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Hyderabad, Andhra Pradesh, India
Kingsway Hospital
🇮🇳
Nagpur, Maharashtra, India
Kailash Cancer Hospital & Research Centre (KCHRC)
🇮🇳
Waghodia, Gujarat, India