Phase 4 N=200 Treatment

A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

Breast Neoplasms · Neoplasm Metastasis

Bottom Line

View on ClinicalTrials.gov: NCT04707196 ↗

Enrolled (actual)

200

Serious AEs

7.0%

Results posted

Nov 2023

Primary outcome: Primary: Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event — 78.1; 69.8 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Abemaciclib (Drug); Nonsteroidal Aromatase Inhibitor (NSAI) (Drug); Fulvestrant (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Eli Lilly and Company
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event	78.1; 69.8	—
SECONDARY Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events	3.6; 4.8	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04707196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.