A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

  • STATUS
    Recruiting
  • End date
    Mar 3, 2023
  • participants needed
    200
  • sponsor
    Eli Lilly and Company
Updated on 23 May 2022
cancer
breast cancer
growth factor
biological factors
hormone therapy
advanced breast cancer
epidermal growth factor receptor
HER2
EGFR
fulvestrant
erbb2
epidermal growth factor
aromatase inhibitor
anastrozole
letrozole

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.

Details
Condition Breast Neoplasms, Neoplasm Metastasis
Treatment fulvestrant, Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI)
Clinical Study IdentifierNCT04707196
SponsorEli Lilly and Company
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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