Recruiting • Phase III • Stage III, IV • HER2 negative • Post-Menopausal • Brain Metastases absent • Interventional
The following is imported from ClinicalTrials.gov:
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.
Breast Cancer
Study Design
Study type:
Interventional
Estimated enrollment:
350 participant
Actual study start date:
March 11, 2022
Eligibility Criteria
Ages eligible for study:
18 - 999
Sexes eligible for study:
both
Arms and Intervention
Abemaciclib
Fulvestrant
Placebo
Inclusion criteria
have a diagnosis of hr+, her2- locally advanced or metastatic breast cancer
have radiologic evidence of disease progression or recurrence either
on treatment with a cdk4/6 inhibitor with aromatase inhibitor (ai) as initial therapy for advanced disease, or
on/after treatment with a cdk4/6 inhibitor plus endocrine therapy (et) administered as adjuvant therapy for early stage breast cancer
must be deemed appropriate for treatment with et
if female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
have response evaluable criteria in solid tumors (recist) evaluable disease (measurable disease and/or nonmeasurable disease)
have a performance status of 0 or 1 on the eastern cooperative oncology group scale (oken et al. 1982)
have adequate renal, hematologic, and hepatic organ function
must be able to swallow capsules/tablets
Exclusion criteria
have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
have symptomatic or untreated central nervous system metastasis
have received any systemic therapy between disease recurrence/progression and study screening
have received more than 1 line of therapy for advanced or metastatic disease.
have received prior chemotherapy for metastatic breast cancer (mbc)
have received prior treatment with fulvestrant, any investigational estrogen receptor (er)-directed therapy (including selective er degraders [serds] and non-serds), any phosphatidylinositol 3-kinase (pi3k)-, mammalian target of rapamycin (mtor)-, or protein kinase b (akt)-inhibitor