A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04707196
Collaborator
(none)
200
16
1
24.3
12.5
0.5

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

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 22, 2021
Anticipated Primary Completion Date :
Mar 3, 2023
Anticipated Study Completion Date :
Mar 3, 2023

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:
  • LY2835219
  • Drug: Nonsteroidal Aromatase Inhibitor (NSAI)
    Letrozole administered orally or anastrozole administered orally (physician choice)

    Drug: Fulvestrant
    Administered intramuscularly

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    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.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04707196
    Other Study ID Numbers:
    • 17782
    • I3Y-IN-JPEC
    First Posted:
    Jan 13, 2021
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2022