A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Arm, Phase 4 Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, in Combination With Endocrine Therapy (Anastrozole/Letrozole or Fulvestrant) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced and/or Metastatic Breast Cancer in India

Conditions
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Breast Neoplasms, Neoplasm Metastasis

Intervention / Treatment
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* Drug: Abemaciclib
* Drug: Nonsteroidal Aromatase Inhibitor (NSAI)
* Drug: Fulvestrant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abemaciclib + NSAI or Fulvestrant<br>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. | Drug: Abemaciclib<br>* Administered orally<br>* Other names: LY2835219;Drug: Nonsteroidal Aromatase Inhibitor (NSAI)<br>* Letrozole or anastrozole administered orally (physician choice)<br>Drug: Fulvestrant<br>* Administered intramuscularly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline until end of follow-up (Up To 7 Months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline until end of study treatment (Up To 6 Months) |