Abemaciclib + Elacestrant for Brain Metastasis from Breast Cancer
(ELECTRA Trial)
Recruiting in Palo Alto (17 mi)
+88 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Stemline Therapeutics, Inc.
Must not be taking: CYP3A4 inducers/inhibitors, Herbal meds
Disqualifiers: Leptomeningeal metastases, Concurrent malignancy, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial tests a combination of two drugs, elacestrant and abemaciclib, in patients with a specific type of breast cancer. It aims to find the best dose and see how well it works for those whose cancer has spread to the brain. The drugs work by blocking signals that help cancer cells grow and divide. Abemaciclib is a drug that has been approved for the treatment of certain advanced breast cancers.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot take certain medications like strong or moderate inducers or inhibitors of CYP3A4, some herbal preparations, or receive vaccinations within specific timeframes before starting the trial.
What data supports the effectiveness of the drug Abemaciclib for treating brain metastasis from breast cancer?
Research shows that Abemaciclib is effective in treating hormone receptor-positive breast cancer, including cases with brain metastases, by improving progression-free survival and reducing the risk of cancer recurrence when combined with endocrine therapy.
12345Is the combination of Abemaciclib and Elacestrant safe for treating brain metastasis from breast cancer?
Abemaciclib has been studied for safety in various breast cancer treatments, showing manageable side effects like diarrhea, infections, and low white blood cell counts. While specific safety data for the combination with Elacestrant in brain metastasis is not detailed, Abemaciclib alone has an acceptable safety profile in other breast cancer contexts.
13456How is the drug Abemaciclib + Elacestrant unique for treating brain metastasis from breast cancer?
This treatment is unique because it combines Abemaciclib, a CDK4/6 inhibitor that targets specific proteins to stop cancer cell growth, with Elacestrant, a selective estrogen receptor degrader, potentially offering a novel approach for patients with brain metastases from hormone receptor-positive breast cancer, where standard treatments are limited.
23457Eligibility Criteria
This trial is for men and women over 18 with brain metastases from ER-positive, HER-2 negative breast cancer. They must have had prior treatments including endocrine therapy and chemotherapy, be stable neurologically for at least 2 weeks, and not be breastfeeding or pregnant. Participants need to have good organ function and performance status, cannot have leptomeningeal metastases or imminent organ failure, and must agree to use effective contraception.Inclusion Criteria
Your blood, bone marrow, and organ functions are within normal range, and you are able and willing to attend all study appointments and follow the study's instructions.
My cancer is ER-positive and HER-2 negative, confirmed by a test within the last 2 years.
I can take care of myself but might not be able to do heavy physical work.
My cancer has worsened or returned after my last treatment.
Exclusion Criteria
I have not taken elacestrant or similar drugs for my cancer.
I do not have any severe ongoing infections.
I have not had major surgery in the last 4 weeks.
I am not pregnant or breastfeeding.
My cancer has spread to the lining of my brain and spinal cord.
I am experiencing a severe health crisis due to organ failure.
I cannot take pills by mouth or have a condition that affects how my body absorbs food.
Participant Groups
The study is testing the combination of two drugs: Elacestrant and Abemaciclib in patients with brain metastasis due to hormone receptor-positive (HR+)/HER2-negative breast cancer. It's an open-label global study that will first determine the best dose (Phase 1b) followed by a larger test of effectiveness (Phase 2).
4Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment2 Interventions
Elacestrant in combination with abemaciclib at the recommended phase 2 dose (RP2D) determined in phase 1b
Group II: Phase 1b Cohort 3Experimental Treatment2 Interventions
Elacestrant 400 mg QD + abemaciclib 150 mg BID
Group III: Phase 1b Cohort 2Experimental Treatment2 Interventions
Elacestrant 400 mg QD + abemaciclib 100 mg BID
Group IV: Phase 1b Cohort 1Experimental Treatment2 Interventions
Elacestrant 300 mg once daily (QD) + abemaciclib 100 mg twice daily (BID)
Abemaciclib is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Verzenio for:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
🇪🇺 Approved in European Union as Verzenio for:
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
SCRI Oncology PartnersNashville, TN
Providence Medical FoundationFullerton, CA
University of Texas MD Anderson Cancer CenterHouston, TX
Dana-Farber Cancer InstituteBoston, MA
More Trial Locations
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Who is running the clinical trial?
Stemline Therapeutics, Inc.Lead Sponsor
Stemline Therapeutics, Inc.Lead Sponsor
References
Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence. [2023]Abemaciclib [Verzenio® (USA) or Verzenios® (EU)] is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor approved in combination with adjuvant endocrine therapy for patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), node-positive, early breast cancer with a high risk of recurrence. In a phase III trial, abemaciclib plus endocrine therapy reduced the risk of recurrence of breast cancer compared with endocrine therapy alone, including in patients who had previously received neoadjuvant chemotherapy, in patients with high- and low-scoring Ki-67 tumours, and in both premenopausal and postmenopausal patients. The tolerability profile of abemaciclib plus endocrine therapy was acceptable and manageable, with diarrhoea, infections and neutropenia being the most common adverse events. Thus, abemaciclib in combination with standard endocrine therapy is a valuable additional treatment option for patients with HR+, HER2-, node-positive early breast cancer with a high risk of recurrence.
Observational study of HR+/HER2- metastatic breast cancer patients treated with abemaciclib in Spain in the Named Patient Use Program (AbemusS). [2023]To describe abemaciclib use in patients with hormone receptor-positive, human epidermal growth factor receptor-negative (HR+/HER2-) metastatic breast cancer (mBC) who participated in the Named Patient Use program (NPU) in Spain.
A Phase II Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor-Positive Breast Cancer. [2021]Label="PURPOSE">The primary objective was to evaluate intracranial objective response rate (iORR) in patients receiving abemaciclib with brain or leptomeningeal metastases (LM) secondary to hormone receptor-positive (HR+) metastatic breast cancer (MBC). Secondary objectives evaluated extracranial response, abemaciclib pharmacokinetics, brain metastases tissue exposure, and safety.
First-Line Abemaciclib Effective in ER+ Breast Cancer. [2019]Interim data from the MONARCH3 study indicate that abemaciclib is an effective first-line therapy for advanced ER-positive, HER2-negative breast cancer. Adding the investigational CDK4/6 inhibitor to letrozole significantly improved patients' progression-free survival, compared with those given a placebo alongside endocrine therapy.
Cost-effectiveness analysis of abemaciclib with endocrine therapy (ET) versus ET alone for HR+, HER2-, node-positive, high-risk early breast cancer in Italy. [2023]Abemaciclib was recently approved by the European Medicines Agency in combination with adjuvant endocrine therapy (ET) for adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), node-positive early breast cancer (EBC) at high risk of recurrence.
Abemaciclib: First Global Approval. [2019]Abemaciclib (Verzenio™) is an orally administered inhibitor of cyclin-dependent kinases 4 and 6 that is being developed by Eli Lilly and Company. Abemaciclib has been approved in the USA for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with fulvestrant in women with disease progression following endocrine therapy, and as monotherapy in adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. In addition, abemaciclib is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of abemaciclib leading to its first approval for the treatment of patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
MONARCH 1, A Phase II Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, as a Single Agent, in Patients with Refractory HR+/HER2- Metastatic Breast Cancer. [2019]Purpose: The phase II MONARCH 1 study was designed to evaluate the single-agent activity and adverse event (AE) profile of abemaciclib, a selective inhibitor of CDK4 and CDK6, in women with refractory hormone receptor-positive (HR+), HER2- metastatic breast cancer (MBC).Experimental Design: MONARCH 1 was a phase II single-arm open-label study. Women with HR+/HER2- MBC who had progressed on or after prior endocrine therapy and had 1 or 2 chemotherapy regimens in the metastatic setting were eligible. Abemaciclib 200 mg was administered orally on a continuous schedule every 12 hours until disease progression or unacceptable toxicity. The primary objective of MONARCH 1 was investigator-assessed objective response rate (ORR). Other endpoints included clinical benefit rate, progression-free survival (PFS), and overall survival (OS).Results: Patients (n = 132) had a median of 3 (range, 1-8) lines of prior systemic therapy in the metastatic setting, 90.2% had visceral disease, and 50.8% had ≥3 metastatic sites. At the 12-month final analysis, the primary objective of confirmed objective response rate was 19.7% (95% CI, 13.3-27.5; 15% not excluded); clinical benefit rate (CR+PR+SD≥6 months) was 42.4%, median progression-free survival was 6.0 months, and median overall survival was 17.7 months. The most common treatment-emergent AEs of any grade were diarrhea, fatigue, and nausea; discontinuations due to AEs were infrequent (7.6%).Conclusions: In this poor-prognosis, heavily pretreated population with refractory HR+/HER2- metastatic breast cancer, continuous dosing of single-agent abemaciciclib was well tolerated and exhibited promising clinical activity. Clin Cancer Res; 23(17); 5218-24. ©2017 AACR.