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Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
EU CTIS ID: 2023-506771-10-00
What this study is testing
To compare the efficacy of fulvestrant with or without abemaciclib
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Turkey
- Korea, Republic of
- Mexico
- Taiwan
- United States
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Turkey; Korea, Republic of; Mexico; Taiwan; United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.