Abemaciclib + Elacestrant for Breast Cancer with Brain Metastasis

Not currently recruiting at 2 trial locations

Overseen By Ruth Stone

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Criterium, Inc.

Must not be taking: Abemaciclib, Elacestrant

Disqualifiers: Pregnancy, Under 18, Serious medical conditions, Infections, Cardiovascular history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for breast cancer that has spread to the brain. Researchers are testing a combination of two drugs, abemaciclib (a targeted therapy) and elacestrant (a hormone therapy), to determine if they can control the cancer and improve symptoms. This study may suit post-menopausal women with HR+/Her2- breast cancer with brain metastasis who have already tried up to two other chemotherapy treatments. Participants will help researchers assess the effectiveness of this new drug combination for this specific cancer type. As a Phase 1, Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer research.

Will I have to stop taking my current medications?

The trial requires a washout period of at least 14 days for any prior anti-cancer therapies before starting the study treatment. However, the protocol does not specify if you need to stop other medications, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is examining the safety of using a combination of two drugs, abemaciclib and elacestrant, to treat breast cancer that has spread to the brain. Studies have shown that both drugs can reach the brain, which is crucial for treating cancer there.

Early results suggest that this drug combination is generally well-tolerated. In previous studies, patients experienced manageable side effects, with diarrhea and nausea being the most common, though not severe for most.

This drug combination has shown promise in treating certain types of advanced breast cancer. While research continues, current data provides some reassurance about the safety of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for breast cancer?

Researchers are excited about Abemaciclib and Elacestrant because they bring a fresh approach to treating breast cancer with brain metastasis. Unlike traditional treatments that often focus on chemotherapy or hormone therapy, Abemaciclib is a CDK4/6 inhibitor, which works by blocking certain proteins that cancer cells need to grow. Elacestrant is a selective estrogen receptor degrader (SERD) that targets and breaks down estrogen receptors on cancer cells, potentially reducing their growth. This combination aims to disrupt cancer cell proliferation more effectively and specifically, offering hope for better outcomes in this challenging condition.

What evidence suggests that this treatment might be an effective treatment for breast cancer with brain metastasis?

Research has shown that using abemaciclib and elacestrant together effectively treats a type of advanced breast cancer called ER-positive/HER2-negative. This combination can also reach the brain, which is crucial for treating cancer that has spread there. In this trial, participants will receive the combination of abemaciclib and elacestrant. Patients with similar breast cancer have benefited from these treatments. Although more research is needed, these early findings offer hope for those with breast cancer that has spread to the brain. ^{1 2 3 4 6}

Who Is on the Research Team?

Peter Kabos, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for post-menopausal women with HR+/Her2- breast cancer that has spread to the brain. They can have had up to two chemotherapy treatments for advanced disease but must be recovered from major treatment effects. Participants need good organ function, no severe medical conditions, and not be on other investigational drugs. They cannot have used Abemaciclib or Elacestrant before.

Inclusion Criteria

My organs are functioning well.

I am post-menopausal based on age, surgery, or hormone levels.

I can take pills by mouth.

Exclusion Criteria

I have not had any cancer other than skin or early cervical cancer in the last 5 years.

I am a woman and have not gone through menopause.

I have no conditions that prevent me from taking pills.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abemaciclib and elacestrant combination therapy, with dose adjustments for toxicity

24 weeks

Regular visits for treatment and monitoring

Safety Analysis

Safety analysis conducted after accrual of first 10 patients to assess treatment emergent adverse events

Ongoing during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abemaciclib
• Elacestrant

Trial Overview The study tests a combination of Abemaciclib and Elacestrant in patients whose breast cancer has metastasized to the brain. It's an open-label Phase Ib/II trial allowing prior endocrine therapy use, aiming to assess the effectiveness and safety of this drug combo.

How Is the Trial Designed?

Group I: Abemaciclib/Elacestrant Experimental Treatment 2 Interventions

Abemaciclib and Elacestrant combination

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

Who Is Running the Clinical Trial?

Criterium, Inc.

Lead Sponsor

Trials

18

Recruited

730+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05386108

NCT05386108 | Study of Abemaciclib and Elacestrant in ... This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.1064

Elacestrant in combination with abemaciclib in patients (pts ... ELECTRA (NCT05386108) phase 1b is evaluating the safety of elacestrant + abemaciclib in pts regardless of metastases site and ESR1 status.

3. onclive.com onclive.com/view/elacestrant-plus-abemaciclib-shows-efficacy-in-er-her2-advanced-or-metastatic-breast-cancer

Elacestrant Plus Abemaciclib Shows Efficacy in ER+/HER2 Elacestrant plus abemaciclib demonstrated clinically important efficacy in ER-positive/HER2-negative advanced or metastatic breast cancer.

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)01831-3/fulltext

364P Elacestrant in combination with abemaciclib ... Phase 2 will evaluate the efficacy and safety of the combination in pts with brain mets as both compounds have also been shown to cross the BBB (Conlan, 2020; ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11847623/

Elacestrant in hormone receptor-positive metastatic breast ... Elacestrant shows promise for improving outcomes in hormone receptor-positive metastatic breast cancer, but further research is needed to confirm its ...

6. asco.org asco.org/abstracts-presentations/ABSTRACT459260

Elacestrant in combination with abemaciclib in patients (pts ... For phase 2, presence of ≥1 active and measurable brain metastases per RECIST v1.1 is required. In the mBC setting, pts must have previously received ≥1 ET, ≤2 ...