Overview

A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

Status:
Terminated
Trial end date:
2020-08-11
Target enrollment:
0
Participant gender:
Female
Summary
The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Albumin-Bound Paclitaxel
Capecitabine
Docetaxel
Fulvestrant
Paclitaxel
Criteria
Inclusion Criteria:

- Participants must be females of post-menopausal status with HR+, HER2- breast cancer
that has spread to internal organs

- Participants must have had at least one endocrine therapy

- Participants must be willing to use a device to answer daily questions about how they
are doing for the duration of their participation in the study

- If participant has diarrhea from a previous treatment, they should talk to their
doctor to ensure they have recovered enough to participate in this study

Exclusion Criteria:

- Participants must not have breast cancer that has spread to the brain if untreated and
with symptoms

- Participants must not have had any systemic treatment after their breast cancer has
spread unless it is endocrine therapy

- Participants must not have certain active infections including HIV or hepatitis

- Participants must not be pregnant or breastfeeding

- Participants must not have certain types of cancers or certain previous cancer
treatments

- Participants must not have certain serious medical conditions, including heart or lung
disease, or have had certain types of tissue or organ transplants