Abemaciclib + Hormone Therapy for Breast Cancer

(BRE-09 Trial)

Recruiting at 1 trial location

Overseen By Mercedes Carrasquillo, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Illinois at Chicago

Must be taking: Endocrine therapy

Disqualifiers: Chronic diarrhea, Active infection, Uncontrolled HIV/AIDS, others

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for individuals with HR+HER2- breast cancer. The study focuses on the effectiveness of abemaciclib, a targeted cancer therapy, when combined with hormone therapy for those at high risk and in the early stages of this cancer. Participants must have early-stage HR+HER2- breast cancer confirmed by a biopsy and be scheduled to receive abemaciclib as part of their treatment plan. The trial aims to ensure the treatment's effectiveness and safety for long-term use. As a Phase 4 trial, it involves an FDA-approved treatment to better understand its benefits for more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with your doctor or the trial team.

What is the safety track record for Abemaciclib in combination with hormone therapy?

Research has shown that abemaciclib, when combined with hormone therapy, is consistently safe. The monarchE trial indicated that patients with early-stage breast cancer generally tolerated the treatment well. Diarrhea and fatigue are the most common side effects, but these can often be managed.

The FDA has already approved abemaciclib for other cancer treatments, confirming its well-understood safety profile. Extensive research has not identified any new safety concerns for patients with high-risk early-stage breast cancer. Overall, evidence supports abemaciclib as a safe option when combined with hormone therapy. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Abemaciclib is unique because it specifically targets enzymes called CDK4 and CDK6, which play a crucial role in the growth of cancer cells. Unlike traditional hormone therapies for breast cancer, which often focus on blocking estrogen receptors, Abemaciclib works by inhibiting these enzymes to stop cancer cells from dividing and growing. Researchers are excited about this treatment because it offers a new way to attack cancer cells, potentially improving outcomes for patients with hormone receptor-positive breast cancer. Additionally, Abemaciclib can be taken orally, providing a more convenient option compared to some intravenous therapies.

What is the effectiveness track record for Abemaciclib in treating breast cancer?

Research has shown that abemaciclib, when combined with hormone therapy, effectively treats high-risk early-stage HR+HER2- breast cancer. Studies have found that this combination significantly lowers the chance of cancer recurrence. Specifically, it reduced the risk of death by about 15.8% compared to hormone therapy alone. Patients using abemaciclib with hormone therapy also tend to live longer. Overall, this treatment significantly improves outcomes for patients with this type of breast cancer. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with early-stage HR+HER2- breast cancer who are prescribed adjuvant abemaciclib. Participants must be in good physical condition (ECOG 0-2), able to consent, not pregnant or breastfeeding, and willing to follow study procedures throughout.

Inclusion Criteria

I have early-stage HR+HER2- breast cancer and am prescribed abemaciclib.

I am not pregnant or breastfeeding, and I have a negative pregnancy test.

I understand and can follow the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Gradual up-titration of abemaciclib dose over a course of 2-3 weeks to decrease the rate of Grade 3 or worse diarrhea

2-3 weeks

Treatment

Participants receive adjuvant abemaciclib in combination with endocrine therapy (ET) for 84 days

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including disease-free survival and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Abemaciclib

Trial Overview The ADE-MI trial tests if increasing the dose of Abemaciclib can maintain its effectiveness when given alongside standard endocrine therapy for high-risk early-stage breast cancer after initial treatment.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

In a study involving 5637 patients with high-risk hormone receptor-positive, HER2-negative early breast cancer, the addition of abemaciclib to standard endocrine therapy significantly improved invasive disease-free survival, with a 6.4% absolute difference at 4 years.

While the treatment showed a sustained benefit in reducing recurrence risk, safety concerns were noted, including higher rates of serious adverse events and treatment-related deaths in the abemaciclib group compared to endocrine therapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Johnston, SRD., Toi, M., O'Shaughnessy, J., et al.[2023]

Abemaciclib is an oral medication that inhibits cyclin-dependent kinases 4 and 6, specifically approved in the USA for treating advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative.

It is effective both as a combination therapy with fulvestrant for patients who have progressed after endocrine therapy and as a standalone treatment for those who have also undergone chemotherapy, highlighting its role in advanced cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abemaciclib: First Global Approval. Kim, ES.[2019]

In phase III clinical trials (MONARCH 2 and MONARCH 3), abemaciclib, a CDK4 & 6 inhibitor, significantly improved progression-free survival and overall survival in women with hormone receptor positive (HR+) and HER2-negative advanced breast cancer when used in combination with endocrine therapy.

Abemaciclib demonstrated a tolerable safety profile, making it a promising treatment option for patients who have progressed after previous endocrine therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of CDK4 & 6 Inhibitor Abemaciclib in Breast Cancer]. Masuda, N., Saji, S., Kawaguchi, T., et al.[2021]

Abemaciclib combined with endocrine therapy (ET) significantly improves quality-adjusted life years (QALYs) in patients with high-risk hormone receptor positive, HER2-negative early breast cancer, with an increase of 0.99 QALYs compared to ET alone.

The treatment is considered cost-effective in Italy, with an incremental cost-effectiveness ratio of €22,651 per QALY gained, and a 99% likelihood of being cost-effective at a threshold of €30,000 per QALY.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis of abemaciclib with endocrine therapy (ET) versus ET alone for HR+, HER2-, node-positive, high-risk early breast cancer in Italy. Davie, A., Traoré, S., Giovannitti, M., et al.[2023]

In the nextMONARCH study involving women with endocrine-refractory HR+, HER2- metastatic breast cancer, abemaciclib showed a median progression-free survival (PFS) of 9.1 months when combined with tamoxifen, but this was not significantly better than the 7.4 months PFS with abemaciclib alone plus prophylactic loperamide.

The study found that the incidence and severity of diarrhea, a common side effect of abemaciclib, were manageable with dose adjustments and antidiarrheal medication, indicating that the treatment can be tolerated while maintaining its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

nextMONARCH: Abemaciclib Monotherapy or Combined With Tamoxifen for Metastatic Breast Cancer. Hamilton, E., Cortes, J., Ozyilkan, O., et al.[2021]

Interim results from the MONARCH3 study show that abemaciclib, a CDK4/6 inhibitor, is an effective first-line treatment for advanced ER-positive, HER2-negative breast cancer.

Patients receiving abemaciclib in combination with letrozole experienced significantly improved progression-free survival compared to those receiving a placebo with endocrine therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-Line Abemaciclib Effective in ER+ Breast Cancer. [2019]

In a phase III trial, abemaciclib combined with endocrine therapy significantly reduced the risk of breast cancer recurrence in patients with hormone receptor positive (HR+), HER2-negative, node-positive early breast cancer, regardless of prior chemotherapy or tumor characteristics.

The combination treatment was generally well-tolerated, with manageable side effects such as diarrhea, infections, and neutropenia, making it a valuable option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence. Fung, S., Blair, HA.[2023]

In a phase III trial, adding abemaciclib to adjuvant endocrine therapy significantly improved invasive disease-free survival and distant relapse-free survival in patients with hormone receptor-positive, HER2-negative, high-risk, early breast cancer.

This finding contrasts with results from a trial involving another CDK4/6 inhibitor, which did not show similar benefits, highlighting the variability in efficacy among different treatments in this class.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abemaciclib Reigns Over Breast Cancer in MonarchE. [2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04752332

NCT04752332 | A Study of Abemaciclib (LY2835219) Plus ... The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery.

2. investor.lilly.com investor.lilly.com/node/52836/pdf

Lilly's Verzenio® (abemaciclib) increases overall survival ... Treatment with two years of Verzenio plus endocrine therapy (ET) demonstrated a statistically significant and clinically meaningful improvement ...

3. onclive.com onclive.com/view/abemaciclib-plus-endocrine-therapy-provides-os-benefit-in-hr-her2-negative-breast-cancer

Abemaciclib Plus Endocrine Therapy Provides OS Benefit ... Abemaciclib plus endocrine therapy reduced death risk by 15.8% in high-risk early breast cancer patients compared to endocrine therapy alone.

4. ajmc.com ajmc.com/view/abemaciclib-plus-endocrine-therapy-improves-overall-survival-in-high-risk-early-breast-cancer

Abemaciclib Plus Endocrine Therapy Improves Overall ... At 60, 72, and 84 months, OS rates were 91.2%, 89.2%, and 86.8% in the abemaciclib plus ET arm vs 90.2%, 87.9%, and 85.0% in the ET arm. In both ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK609559/

Abemaciclib (Verzenio) - NCBI Bookshelf - NIH Evidence from a clinical trial demonstrated that patients treated with Verzenio in combination with endocrine therapy experienced a delayed return of cancer.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK601722/

Clinical Review - Abemaciclib (Verzenio) - NCBI Bookshelf - NIH Data from the monarchE trial show a similar safety profile of adjuvant abemaciclib in the early breast cancer setting. Overall, the most common ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2017/208716Orig1s000RiskR.pdf

208716Orig1s000 - accessdata.fda.gov 5 Risk Assessment & Safe-Use Conditions. The safety profile of abemaciclib for the proposed indications is based on safety data from the Phase 3.

8. prnewswire.com prnewswire.com/news-releases/lillys-verzenio-abemaciclib-prolonged-survival-in-hr-her2--high-risk-early-breast-cancer-with-two-years-of-treatment-302586849.html

Lilly's Verzenio® (abemaciclib) prolonged survival in HR+, ... In metastatic breast cancer, Verzenio has demonstrated statistically significant OS in the Phase 3 MONARCH 2 study.11 Verzenio has shown a ...