18 Participants Needed

Endocrine Therapy + Abemaciclib for Breast Cancer

KH
JC
Overseen ByJaycee Cushman
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Duke University
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

The purpose of this study is to perform an in depth analysis of changes in the tumor immune microenvironment in patients undergoing treatment with standard of care endocrine therapy and abemaciclib in the advanced setting via singe cell RNA sequencing. The investigators will also correlate changes in serum estrogen levels to changes in tumor and peripheral immune cell repertoire and function (including regulatory T cell populations, B cells, myeloid-derived suppressor cell populations, T cell activation and T cell exhaustion).This study has two cohorts with 15 patients in each cohort.

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

The trial does not specify if you need to stop taking your current medications. However, it mentions a 21-day washout period for those who have received chemotherapy before starting the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Abemaciclib in combination with endocrine therapy for breast cancer?

Research shows that Abemaciclib, when combined with endocrine therapy, significantly reduces the risk of breast cancer recurrence and improves progression-free survival in patients with hormone receptor-positive, HER2-negative breast cancer. This combination has been effective in both early and advanced stages of the disease, providing a valuable treatment option for patients at high risk of recurrence.12345

Is the combination of endocrine therapy and abemaciclib safe for breast cancer treatment?

The combination of endocrine therapy and abemaciclib has been shown to have a tolerable safety profile in breast cancer treatment, with common side effects including diarrhea, infections, and low white blood cell counts (neutropenia). Most side effects were manageable, and the treatment was generally well-tolerated in clinical trials.12346

How is the drug combination of Abemaciclib and endocrine therapy unique for breast cancer treatment?

The combination of Abemaciclib with endocrine therapy is unique because it specifically targets hormone receptor-positive, HER2-negative breast cancer with a high risk of recurrence, improving outcomes like disease-free survival compared to endocrine therapy alone. Abemaciclib works by inhibiting proteins (CDK4/6) that help cancer cells grow, making it a valuable addition to standard treatments.13457

Research Team

SS

Sarah Sammons, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for women over 18 with advanced ER+/HER2- breast cancer who can swallow pills, have good organ function, and can undergo biopsies. They should not be using hormonal birth control or have active cancers (except certain skin cancers), autoimmune diseases, serious infections, or conditions that make biopsy unsafe.

Inclusion Criteria

My organs are functioning well.
I have a tumor from breast cancer that can be biopsied.
I have fully recovered from any side effects of my recent radiotherapy.
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Exclusion Criteria

I do not have serious health issues that would stop me from joining this study.
I am on blood thinners due to a history of blood clots or heart conditions.
I have a bleeding disorder that makes biopsies unsafe for me.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care endocrine therapy and abemaciclib, with changes in tumor immune microenvironment analyzed

2 years
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Abemaciclib
  • Aromatase Inhibitors
  • Fulvestrant
Trial OverviewThe study tests how standard endocrine therapy plus abemaciclib affects immune cells in the tumor environment of breast cancer patients. It involves detailed analysis through single cell RNA sequencing and monitoring changes related to serum estrogen levels.
Participant Groups
2Treatment groups
Active Control
Group I: Cohort 1Active Control2 Interventions
Fulvestrant plus abemaciclib
Group II: Cohort 2Active Control2 Interventions
Aromatase inhibitor plus abemaciclib (with or without ovarian suppression)

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Findings from Research

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.
Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence.Fung, S., Blair, HA.[2023]
In a phase III study involving 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer, abemaciclib significantly improved progression-free survival compared to placebo, with a hazard ratio of 0.54, indicating a strong efficacy as initial therapy.
The most common side effect of abemaciclib was diarrhea, occurring in 81.3% of patients, but most cases were mild (grade 1), suggesting that while there are some adverse effects, the treatment has a tolerable safety profile.
MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer.Goetz, MP., Toi, M., Campone, M., et al.[2022]
In a pooled analysis of 1152 patients from the MONARCH 2 and MONARCH 3 studies, abemaciclib combined with endocrine therapy showed a consistent improvement in progression-free survival (PFS) across all age groups, indicating its efficacy in treating HR+, HER2- advanced breast cancer regardless of age.
Older patients experienced higher rates of clinically relevant side effects, such as diarrhea and nausea, but these were manageable with dose adjustments, suggesting that while safety concerns exist, the treatment remains effective for older populations.
Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials.Goetz, MP., Okera, M., Wildiers, H., et al.[2022]

References

Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence. [2023]
MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. [2022]
Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. [2022]
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 Reigns Over Breast Cancer in MonarchE. [2021]
MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. [2023]
First-Line Abemaciclib Effective in ER+ Breast Cancer. [2019]