A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

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

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 Overview

• Status: Completed
• Conditions: Breast Neoplasms; Neoplasm Metastasis
• Intervention / Treatment: Drug: Abemaciclib; Drug: Fulvestrant; Drug: Nonsteroidal Aromatase Inhibitor (NSAI)

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160055
    • Max Superspeciality Hospital
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500004
      • MNJ Institute of Oncology
  • Bihar
    • Patna, Bihar, India, 800014
      • Indira Gandhi Institute of Medical Sciences
  • Delhi
    • New Delhi, Delhi, India, 110085
      • Rajiv Gandhi Cancer Institute And Research Centre
  • Gujarat
    • Surat, Gujarat, India, 395002
      • Nirmal Hospital Pvt Ltd.
    • Surat, Gujarat, India, 395002
      • Unique Hospital Multispecialty & Research Institute
    • Waghodia, Gujarat, India, 391760
      • Kailash Cancer Hospital & Research Centre (KCHRC)
  • Karnataka
    • Bengaluru, Karnataka, India, 560020
      • HCG Cancer Centre, Kalinga Rao Road
  • Kerala
    • Trivandrum, Kerala, India, 695011
      • Regional Cancer Centre
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452001
      • SRJ-CBCC Cancer Hospital
  • Maharashtra
    • Nagpur, Maharashtra, India, 440001
      • Kingsway Hospital
    • Nagpur, Maharashtra, India, 440012
      • Meditrina Institute Of Medical Sciences
    • Nashik, Maharashtra, India, 422001
      • HCG Manavata Cancer Centre
    • Pune, Maharashtra, India, 411001
      • Ruby Hall Clinic and Grant Medical Foundation
  • West Bengal
    • Kolkata, West Bengal, India, 700054
      • Apollo Gleneagles Hospitals Kolkata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Abemaciclib + NSAI or 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.

Drug: Abemaciclib; Administered orally; Other Names: LY2835219; Drug: Fulvestrant; Administered intramuscularly; Drug: Nonsteroidal Aromatase Inhibitor (NSAI); Letrozole or anastrozole administered orally (physician choice)

What is the study measuring?

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. 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)

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): January 9, 2023
• Study Completion (Actual): January 9, 2023

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Steroid Synthesis Inhibitors; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant; Aromatase Inhibitors
• Other Study ID Numbers: 17782; I3Y-IN-JPEC (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes