What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly endocrine therapies like tamoxifen, aromatase inhibitors (e.g., anastrozole), and Selective Estrogen Receptor Degraders (SERDs) such as Imlunestrant, have several known side effects. Tamoxifen can cause hot flashes, increased risk of blood clots, and endometrial cancer. Aromatase inhibitors are associated with bone density loss, fractures, and cardiovascular risks. SERDs like Imlunestrant may share similar side effects, including hot flashes and potential bone density reduction, but specific side effect profiles can vary and are subject to ongoing research.

What prior FDA approvals exist?

The FDA has approved several endocrine therapies for the treatment of breast cancer, particularly for estrogen receptor-positive (ER+) types. Fulvestrant, a Selective Estrogen Receptor Degrader (SERD), is one such drug that has been approved for advanced breast cancer. It works by binding to the estrogen receptor and promoting its degradation, thereby inhibiting the growth of cancer cells. Other related endocrine therapies include aromatase inhibitors like letrozole and anastrozole, which reduce estrogen levels in the body, and selective estrogen receptor modulators (SERMs) like tamoxifen, which block estrogen receptors on breast cancer cells. These treatments are often used in various stages of breast cancer, including early and advanced stages, to improve progression-free survival and overall outcomes.

What other types of research exist?

Promising alternatives to Imlunestrant for breast cancer treatment include Elacestrant, which has demonstrated significant progression-free survival superiority over standard endocrine therapies in metastatic breast cancer. Additionally, combination therapies involving oral SERDs with CDK4/6 inhibitors are under evaluation and may offer effective treatment options.

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Selective Estrogen Receptor Downregulator (SERD)

Imlunestrant for Early Breast Cancer (EMBER-4 Trial)

Phase 3

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

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

Must have

Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.

Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.

Must not have

Participants with a history of any other cancer.

Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to death from any cause (up to 10 years)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new medication called imlunestrant to see if it works better than standard hormone treatments for certain breast cancer patients. The study focuses on patients with early-stage breast cancer that is estrogen receptor positive and HER2 negative, who have already been on hormone therapy for a period of time and are at high risk of their cancer returning. Imlunestrant works by blocking estrogen from helping cancer cells grow.

Who is the study for?

This trial is for people with early-stage breast cancer that's ER+ and HER2-, who've finished 2-5 years of hormone therapy but still have a high risk of the cancer coming back. They should be in good health, not have had certain other cancers or gaps in their previous treatment, and can't be pregnant or planning to become so during the study.

What is being tested?

The trial tests Imlunestrant against standard endocrine therapies like Tamoxifen, Anastrozole, Letrozole, and Exemestane. It aims to see if Imlunestrant is more effective for those at higher risk of breast cancer recurrence after initial hormone therapy.

What are the potential side effects?

While specific side effects are not listed here, common ones from endocrine therapies may include hot flashes, fatigue, joint pain, mood swings, decreased sex drive and bone thinning. The new drug's side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is early-stage, ER+ and HER2-, with no distant spread.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have had cancer before.

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I have taken medication (like tamoxifen or AIs) for breast cancer prevention.

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I had a break of more than 6 months in my hormone therapy for cancer.

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My breast cancer was advanced or inflammatory at diagnosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to death from any cause (up to 10 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to death from any cause (up to 10 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to death from any cause (up to 10 years) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Invasive Disease-Free Survival (IDFS)

Secondary study objectives

Change from Baseline in the EORTC QLQ-C30 Global QOL

Change from Baseline in the EORTC QLQ-C30 Role Functioning

Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning

+4 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ImlunestrantExperimental Treatment1 Intervention

Imlunestrant administered orally.

Group II: Investigator's Choice of Endocrine TherapyActive Control4 Interventions

Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imlunestrant

2022

Completed Phase 1

~170

0 / 6Eligibility 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

Breast cancer treatments often target hormone receptors due to the role of estrogen in promoting cancer cell growth. Selective Estrogen Receptor Degraders (SERDs) like Imlunestrant work by binding to estrogen receptors on cancer cells, leading to their degradation and preventing estrogen from stimulating cancer growth. Aromatase inhibitors, another common treatment, reduce estrogen production in postmenopausal women, thereby limiting the hormone's availability to cancer cells. Chemotherapy, used in more advanced or aggressive cases, targets rapidly dividing cells, including cancer cells, to inhibit their growth and spread. Understanding these mechanisms is crucial for breast cancer patients as it helps tailor treatments to their specific cancer type, improving efficacy and potentially reducing side effects.