Clinical Trials

Study Title

A Multicenter, Open-Label, Randomized-Controlled Study of Abemaciclib, a CDK4 & 6 Inhibitor, in Combination with Fulvestrant Compared to Chemotherapy in Women with HR Positive, HER2 Negative Metastatic Breast Cancer with Visceral Metastases

Purpose

To compare the efficacy of abemaciclib in combination with fulvestrant to that of physician’s choice of chemotherapy in patients with HR+, HER2- metastatic breast cancer with at least 1 site of visceral metastases & at least 1 line of prior Endocrine Therapy.

Eligibility

Postmenopausal females at least 18 years of age.

Candidates for single agent chemotherapy or abemaciclib/fulvestrant combination therapy.

Confirmed HR+, HER2- recurrent, locally advanced, unresectable, or metastatic breast cancer with evidence of relapse or disease progression on or following endocrine therapy.

Must have metastatic disease with at least 1 site of visceral metastasis.

You Cannot:  Have received prior systemic therapy for metastatic disease except endocrine therapy.

Have CNS metastasis

Have received prior treatment with fulvestrant

Study Process

This study has 2 study arms.

Stratified based on presence of liver metastases, sensitivity to prior endocrine therapy, & postmenopausal status