A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04707196
• Other study ID #: 17782
• Secondary ID: I3Y-IN-JPEC
• Status: Completed
• Phase: Phase 4
• Start date: February 22, 2021
• Est. completion date: January 9, 2023

Study information

• Verified date: November 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• Abemaciclib
Administered orally
• Nonsteroidal Aromatase Inhibitor (NSAI)
Letrozole or anastrozole administered orally (physician choice)
• Fulvestrant
Administered intramuscularly

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)