Elacestrant + Trastuzumab Deruxtecan for Breast Cancer
(ERADICATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two drugs, elacestrant (a type of hormone therapy) and trastuzumab deruxtecan (an antibody-drug conjugate), to determine their safety and effectiveness in treating a specific type of breast cancer. It targets hormone receptor-positive, HER2-low metastatic breast cancer that hasn't responded to certain previous treatments. Individuals with this cancer type, who have experienced progression despite past use of CDK4/6 inhibitors and endocrine therapy, might be suitable candidates. Participants will receive the study drugs and undergo regular imaging and biopsies to monitor their response. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new combination therapy.
Will I have to stop taking my current medications?
The trial requires a 7-day period without taking any endocrine or targeted therapy before starting the study treatment. If you're on such medications, you will need to stop them for at least a week before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have shown that elacestrant and trastuzumab deruxtecan are generally safe. Data from the ELEVATE study indicated that using these drugs together was mostly well-tolerated by patients with advanced breast cancer, with most side effects being mild and manageable.
Trastuzumab deruxtecan has been widely used in other cancer treatments and found effective, with manageable side effects like nausea and tiredness. Similarly, elacestrant has been tested in various contexts, focusing on safety, and patients have generally tolerated it well.
As this trial is in its early stages, the main goal is to ensure safety and determine the best dose. Researchers are closely monitoring for any side effects to protect participants. Always consult your healthcare provider to determine if this trial is suitable for you.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Elacestrant paired with Trastuzumab Deruxtecan because they bring a new approach to treating breast cancer. While standard treatments often focus on hormone blockers or chemotherapy, Elacestrant is a selective estrogen receptor degrader (SERD) that targets estrogen receptors directly, potentially offering a more precise attack on cancer cells. Trastuzumab Deruxtecan, on the other hand, is an antibody-drug conjugate, which combines targeted therapy with chemotherapy, delivering the drug directly to cancer cells with less impact on healthy cells. This combination has the potential to enhance effectiveness while reducing side effects, offering a promising new option for patients.
What evidence suggests that this trial's treatments could be effective for metastatic breast cancer?
Studies have shown that elacestrant is effective for patients with HR-positive, HER2-negative advanced breast cancer, particularly those with an ESR1 mutation. In these patients, the cancer worsened after an average of 8.6 months. Trastuzumab deruxtecan has also delivered promising results, with over a third of patients experiencing tumor shrinkage. Additionally, about 75% of patients achieved some form of disease control, helping to manage cancer progression. This trial will explore the combination of elacestrant and trastuzumab deruxtecan, which could potentially enhance their effectiveness, as both have demonstrated benefits in treating advanced breast cancer.15678
Who Is on the Research Team?
Sarah Sammons, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for individuals with HR+/HER2-low or HER2-ultralow metastatic breast cancer that hasn't responded to previous CDK4/6 inhibitor and endocrine therapies. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase Ib Treatment
Dose-escalation to determine the recommended phase II dose of Elacestrant in combination with trastuzumab deruxtecan
Phase II Treatment
Expansion to evaluate efficacy and safety at the recommended phase II dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Elacestrant
- Trastuzumab Deruxtecan
Trial Overview
The study tests the combination of Elacestrant (selective estrogen receptor degrader) and Trastuzumab Deruxtecan (antibody drug conjugate) in patients with a specific type of advanced breast cancer. It aims to assess the safety and effectiveness of this treatment regimen.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
37 participants will complete the following: * Baseline visit -Cycle 1 (21 day cycle) * Days 1 through 21: Predetermined dose of Elacestrant 1x daily. * Day 1: Predetermined dose of Trastuzumab Deruxtecan 1x daily. -Cycle 2 through End of Treatment (21 day cycle): * Imaging every 9 weeks until Cycle 9, then every 12 weeks * Day 1: tumor biopsy * Days 1 through 21: Predetermined dose of Elacestrant 1x daily. * Day 1: Predetermined dose of Trastuzumab Deruxtecan 1x daily. * End of Treatment visit with imaging * Follow up visits every 6 months
Up to 28 participants will be enrolled to determine the recommended phase 2 dosage of Elacestrant and will complete the following: * Baseline visit * Cycle 1 (21 day cycle) * Days 1 through 21: Predetermined dose of Elacestrant 1x daily. * Day 1: Predetermined dose of Trastuzumab Deruxtecan 1x daily. * Cycle 2 through End of Treatment (21 day cycle): * Imaging every 9 weeks until Cycle 9, then every 12 weeks * Day 1: tumor biopsy * Days 1 through 21: Predetermined dose of Elacestrant 1x daily. * Day 1: Predetermined dose of Trastuzumab Deruxtecan 1x daily. * End of Treatment visit with imaging * Follow up visits every 6 months * If 3 or less out of 12 participants experience a dose-limiting toxicity (DLT), the recommended Phase II dose of Elacestrant will be that dose level. If there are 4 or more DLTs, Elacestrant dosage will de-escalate and 12 more participants will be enrolled.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sarah Sammons, MD
Lead Sponsor
Stemline Therapeutics, Inc.
Industry Sponsor
Citations
ERADICATE: A Phase Ib/II Study of Elacestrant Plus ...
The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone ...
Elacestrant and Trastuzumab Deruxtecan Approvals ...
One was the recent approval of elacestrant for patients with HR-positive, HER2-negative advanced breast cancer who harbor an ESR1 mutation.
Real-world outcomes of trastuzumab deruxtecan in HR ...
The median lines of therapy were 3 (range 1–7). The objective response rate (ORR) was 35.9%, and the disease control rate was 75%. Median real- ...
A meta-analysis
Conclusions: Trastuzumab deruxtecan represents a promising advancement in breast cancer treatment, demonstrating enhanced efficacy. However, its safety profile ...
Two Studies Highlight Benefits in Quality of Life and ...
In patients who had received prior treatment with CDK4/6 inhibitors and had ESR1 mutations, the median progression-free survival was 8.6 months ...
Elacestrant Combinations in ER+/HER2- Locally Advanced ...
Presented by Dr. Hope S. Rugo, this slide deck presents updated phase 1b/2 safety and efficacy results from the ELEVATE trial of elacestrant ...
Safety and efficacy of combined trastuzumab-deruxtecan and ...
This retrospective multicenter study included 54 patients treated concurrently with T-DXd and RT for HER2+ and HER2 low MBC between February ...
8.
dailyreporter.esmo.org
dailyreporter.esmo.org/esmo-breast-cancer-2023/esmo-breast-congress-2023/extended-safety-information-and-pros-data-support-key-trial-results-in-metastatic-breast-cancerPROs data from key trial results in metastatic breast cancer,
Data presentations from DESTINY-Breast04, DESTINY-Breast02 and EMERALD trials confirm the value of trastuzumab deruxtecan and elacestrant.
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