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

Lilly

Status and phase: Terminated; Phase 4

Conditions: Metastatic Breast Cancer

Treatments: Drug: Fulvestrant; Drug: Standard Chemotherapy; Drug: Abemaciclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04031885

17320

I3Y-MC-JPCU (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Abemaciclib + Fulvestrant

Experimental group

Description:

150 milligram (mg) Abemaciclib given orally twice a day (BID) with 500 mg fulvestrant given by intramuscular (IM) injection on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then Day 1 of each subsequent cycle.

Treatment:

Drug: Abemaciclib

Drug: Fulvestrant

Standard Chemotherapy

Active Comparator group

Description:

Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.

Treatment:

Drug: Standard Chemotherapy