CDK 4/6 Inhibitors for Breast Cancer

Recruiting at 1 trial location

Overseen By Estefania Hernandez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must be taking: CDK 4/6 inhibitors

Must not be taking: Corticosteroids

Disqualifiers: BMI < 18.5, Untreated brain metastasis, Uncontrolled diabetes, 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: 6

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how certain cancer drugs, known as CDK 4/6 inhibitors (such as abemaciclib, ribociclib, and palbociclib), might alter body composition in individuals with a specific type of breast cancer. The main focus is on whether these drugs can reduce body fat without affecting muscle mass. Participants should have ER+/HER2- metastatic breast cancer and be starting one of these drugs as part of their regular treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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

The trial does not specify if you need to stop your current medications, but it allows certain therapies like bisphosphonates and RANKL inhibitors. It's best to discuss your specific medications with the trial team.

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

Research has shown that the safety of CDK 4/6 inhibitors, such as abemaciclib, palbociclib, and ribociclib, is well-documented in patients with ER+/HER2- metastatic breast cancer.

Studies indicate that abemaciclib is generally well-tolerated, with diarrhea and tiredness as the most common side effects. Its approval for certain breast cancers further supports its safety.

Palbociclib has been tested extensively, demonstrating a reliable safety record. The most common side effect is neutropenia, or a low white blood cell count, which is usually manageable with proper care.

Ribociclib has also undergone thorough study and is safe when used with hormone therapy for breast cancer. Its side effects are similar to other CDK 4/6 inhibitors, including low white blood cell counts.

Overall, these treatments have established safety records based on their use in many patients. However, individual experiences can vary, so discussing potential side effects with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about treatments like Abemaciclib, Palbociclib, and Ribociclib because they offer a unique approach to treating ER+/HER2- metastatic breast cancer by targeting cyclin-dependent kinase (CDK) 4/6. Unlike traditional chemotherapy that attacks all rapidly dividing cells, these CDK 4/6 inhibitors specifically halt cancer cell division while sparing normal cells, potentially leading to fewer side effects. Additionally, there's hope that these treatments might reduce fat mass without significantly affecting skeletal mass, which could be beneficial for patients' overall health and quality of life.

What evidence suggests that these CDK 4/6 inhibitors could be effective for ER+/HER2- metastatic breast cancer?

Research has shown that CDK 4/6 inhibitors, such as abemaciclib, palbociclib, and ribociclib, effectively treat certain breast cancers. In this trial, participants with ER+/HER2- metastatic breast cancer may receive one of these inhibitors as part of their standard care. Abemaciclib, combined with hormone therapy, reduces the chance of cancer returning by 25%, with 42.7% of patients experiencing tumor shrinkage or disappearance. Palbociclib, also used with hormone therapy, has proven effective for advanced HR-positive/HER2-negative breast cancer, benefiting 69.4% of patients as a first treatment. Ribociclib, similar to the other two, is used with hormone therapy and has shown positive results in similar breast cancer types. These treatments block proteins that cancer cells need to grow, making them effective in these cases. ^{5 6 7 8 9}

Who Is on the Research Team?

Jesus Anampa, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Histologically confirmed adenocarcinoma of the breast that is ER and/or PR positive, Her2 negative based on current ASCO-CAP guidelines

Metastatic or locally advanced/inflammatory, unresectable breast cancer not amenable to potentially curative surgery.

Measurable and/or non-measurable as defined by RECIST 1.1 criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CDK 4/6 inhibitors as part of their standard of care treatment

6 months

Baseline and every 3 months

Follow-up

Participants are monitored for body composition changes and adipose serum biomarkers

18 months

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Abemaciclib
• Palbociclib
• Ribociclib

How Is the Trial Designed?

Group I: ER+/HER2- metastatic breast cancer Experimental Treatment 2 Interventions

Subjects have metastatic ER+/HER2- breast cancer, and their doctor is offering treatment with CDK 4/6 inhibitors as standard of care treatment. It is hypothesized that cyclin-dependent kinase (CDK) 4/6 inhibitors decrease fat mass among women with ER+/HER2- metastatic breast cancer without significant effect in the skeletal mass. Body composition will be obtained from CT scans (CT or PETCT) as part of standard of care, and body fat mass will be obtained from DEXA scan (DEXA will be performed only if available)

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?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Citations

1. 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.

2. lilly.com lilly.com/en-CA/news/press-releases/20.09.24-verzenio-monarchE-study

Verzenio® Significantly Reduced the Risk of Cancer ... Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) significantly decreased the risk of breast cancer recurrence by 25 per cent.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11520550/

Abemaciclib for treating patients with HR+/HER2 Additionally, partial or complete response was achieved by over 42.7% of patients. Effectiveness findings from this real-world retrospective study align with ...

4. oncpracticemanagement.com oncpracticemanagement.com/special-issues/the-evolution-of-abemaciclib-clinical-trial-data-for-the-treatment-of-hr-positive-her2-negative-metastatic-breast-cancer

The Evolution of Abemaciclib Clinical Trial Data for ... HR-positive/HER2-negative breast cancer is traditionally not as aggressive in the localized setting, but the 5-year survival percentage drops heavily to 35.4% ...

5. thelancet.com thelancet.com/journals/lanepe/article/PIIS2666-7762(25)00263-7/fulltext

Prevalence and prognosis of patients with breast cancer ... In this study, we describe the nationwide prevalence and outcomes of patients with breast cancer in Sweden who would be candidates for adjuvant ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/208716s006s007s008lbl.pdf

VERZENIO® (abemaciclib) tablets, for oral use The safety of VERZENIO was evaluated in MONARCH 1, a single-arm, open-label, multicenter study in 132 women with measurable HR-positive, HER2-negative ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7990838/

Safety and efficacy of abemaciclib plus endocrine therapy ... Abemaciclib in combination with endocrine therapy (ET) has demonstrated significant efficacy benefits in HR+ , HER2− advanced breast cancer patients.

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.1079

Elacestrant combinations in patients (pts) with ER+/HER2- ... Elacestrant combinations continue to demonstrate safety consistent with the known profiles of each drug + SOC ET without increased risk of associated AEs.

9. targetedonc.com targetedonc.com/view/expert-reviews-efficacy-safety-data-with-abemaciclib-in-breast-cancer

Expert Reviews Efficacy, Safety Data with Abemaciclib in ... Abemaciclib, the only CDK4/6 inhibitor approved as a single-agent, has amassed several clinical indications for patients with metastatic ...