Clinical trial NCT04707196: A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Neoplasms
Neoplasm Metastasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event
timeFrame: Baseline until end of follow-up (Up To 7 Months)
Secondary outcomes:
measure: Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events
timeFrame: Baseline until end of study treatment (Up To 6 Months)
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: MNJ Institute of Oncology
state: Andhra Pradesh
city: Patna
country: India
facility: Indira Gandhi Institute of Medical Sciences
state: Bihar
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute And Research Centre
state: Delhi
city: Surat
country: India
facility: Nirmal Hospital Pvt Ltd.
state: Gujarat
city: Surat
country: India
facility: Unique Hospital Multispecialty & Research Institute
state: Gujarat
city: Waghodia
country: India
facility: Kailash Cancer Hospital & Research Centre (KCHRC)
state: Gujarat
city: Bengaluru
country: India
facility: HCG Cancer Centre, Kalinga Rao Road
state: Karnataka
city: Trivandrum
country: India
facility: Regional Cancer Centre
state: Kerala
city: Indore
country: India
facility: SRJ-CBCC Cancer Hospital
state: Madhya Pradesh
city: Nagpur
country: India
facility: Kingsway Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Meditrina Institute of Medical Sciences
state: Maharashtra
city: Nashik
country: India
facility: HCG Manavata Cancer Centre
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic and Grant Medical Foundation
state: Maharashtra
city: Kolkata
country: India
facility: Apollo Gleneagles Hospitals Kolkata
state: West Bengal
city: Chandigarh
country: India
facility: Max Superspeciality Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: