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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Administered orally
Letrozole or anastrozole administered orally (physician choice)
Administered intramuscularly
MNJ Institute of Oncology
Hyderabad, Andhra Pradesh, India
Indira Gandhi Institute of Medical Sciences
Patna, Bihar, India
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event
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.
Time frame: Baseline until end of follow-up (Up To 7 Months)
Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events
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.
Time frame: Baseline until end of study treatment (Up To 6 Months)
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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
...and 5 more locations