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

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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)

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

Trial documents
2

Trial contacts and locations

61

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Data sourced from clinicaltrials.gov

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