A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

Lilly

Status and phase: Completed; Phase 4

Conditions: Neoplasm Metastasis; Breast Neoplasms

Treatments: Drug: Fulvestrant; Drug: Abemaciclib; Drug: Nonsteroidal Aromatase Inhibitor (NSAI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04707196

17782

I3Y-IN-JPEC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Abemaciclib + NSAI or Fulvestrant

Experimental group

Description:

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.

Treatment:

Drug: Fulvestrant

Drug: Abemaciclib

Drug: Nonsteroidal Aromatase Inhibitor (NSAI)