What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly CDK4/6 inhibitors like Abemaciclib, can cause side effects such as neutropenia, diarrhea, fatigue, nausea, and alopecia. Endocrine therapies, including tamoxifen and aromatase inhibitors (anastrozole, letrozole, exemestane), often result in hot flashes, joint pain, and an increased risk of osteoporosis. Combining these treatments can improve outcomes but may also increase the incidence of these side effects.

What prior FDA approvals exist?

The FDA has approved several CDK4 and CDK6 inhibitors for the treatment of breast cancer, similar to Abemaciclib. These include Palbociclib (Ibrance), Ribociclib (Kisqali), and Abemaciclib (Verzenio). These drugs are typically used in combination with hormone therapies such as aromatase inhibitors (e.g., Letrozole, Anastrozole) or selective estrogen receptor modulators (e.g., Tamoxifen) for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. These treatments work by inhibiting the activity of CDK4 and CDK6, proteins that promote cell division, thereby slowing the growth of cancer cells.

What other types of research exist?

Promising alternatives to Abemaciclib for breast cancer patients in 2024 include Ribociclib and Palbociclib, which are other CDK4/6 inhibitors with proven efficacy. Additionally, novel agents such as Alpelisib (a PI3K inhibitor) for PIK3CA-mutated breast cancer and Sacituzumab Govitecan (an antibody-drug conjugate) for triple-negative breast cancer are emerging as effective treatments.

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CDK4 and CDK6 inhibitor

High-Dose Abemaciclib for Early-Stage Breast Cancer

Phase 2

Waitlist Available

Led By Erica Mayer, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 14 days must have elapsed between end of radiotherapy and day 1 of treatment with abemaciclib. Participants who received prior radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. No radiotherapy should be planned to occur during study therapy

Women of child-bearing potential and men with partners of childbearing potential must be willing to employ one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 3 months after the last dose of abemaciclib

Must not have

History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest

Individuals with a history of invasive breast cancer are not eligible unless they have been disease-free for a minimum of five years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adjusting the dose of abemaciclib, along with hormone treatments, will cause fewer side effects and be easier for patients with early-stage high-risk hormone receptor positive breast cancer to handle. The treatment works by blocking proteins and hormones that help cancer grow. Abemaciclib has shown potential in improving survival outcomes and quality of life in patients with advanced hormone receptor-positive breast cancer.

Who is the study for?

This trial is for men and women over 18 with high-risk hormone receptor positive, HER2- early-stage breast cancer. They must have completed surgery within the last 16 months, may already be on endocrine therapy, and should not have had chemotherapy or radiotherapy recently. Participants need to use effective nonhormonal contraception and cannot be pregnant or nursing.

What is being tested?

The TRADE study is testing a new way of giving abemaciclib where doses increase over time. This approach aims to see if it's easier for patients to handle than the standard dose. The trial includes other drugs like Tamoxifen and aromatase inhibitors that are commonly used in breast cancer treatment.

What are the potential side effects?

Abemaciclib can cause diarrhea, fatigue, low blood cell counts increasing infection risk, liver problems, deep vein thrombosis (blood clots), pulmonary embolism (clot in lung), and potential harm to an unborn baby.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.

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I am using reliable birth control methods during and 3 months after the study.

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It's been over 3 weeks since my last chemotherapy, and I've recovered from its side effects.

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My breast cancer is stage II or III, affects lymph nodes, is hormone receptor positive and HER2 negative.

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I am fully active or can carry out light work.

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My blood counts and liver function tests are within the required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.

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I have been free from breast cancer for at least 5 years.

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My breast cancer has not spread to my lymph nodes.

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I am allergic to abemaciclib or similar medications.

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I have been diagnosed with inflammatory breast cancer.

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I am not taking any strong medication that affects liver enzymes.

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I do not have an active severe infection requiring IV antibiotics.

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I have been treated with a CDK4/6 inhibitor before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Adverse Rate at 3 months

Secondary study objectives

Composite Rate of Abemaciclib

Dose Intensity of Abemaciclib

Incidence of Grade 2-4 Diarrhea

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AbemaciclibExperimental Treatment6 Interventions

Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1890

Tamoxifen

2005

Completed Phase 4

~30110

Anastrozole

2016

Completed Phase 4

~5550

Letrozole

2002

Completed Phase 4

~3590

Exemestane

2003

Completed Phase 4

~7510

LHRH Agonist

2013

Completed Phase 2

~130

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

CDK4/6 inhibitors, such as Abemaciclib, work by blocking the activity of cyclin-dependent kinases 4 and 6, which are essential for cell cycle progression. This inhibition prevents cancer cells from proliferating. Hormone therapies, including aromatase inhibitors (anastrozole, letrozole) and selective estrogen receptor modulators (tamoxifen), reduce estrogen levels or block estrogen receptors, thereby slowing the growth of hormone receptor-positive breast cancer cells. These treatments are vital as they target specific pathways involved in cancer cell growth, offering more effective and personalized treatment options for patients.

The role of abemaciclib in treatment of advanced breast cancer.