Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study
New trial tests elacestrant vs standard therapy for high-risk early breast cancer
Plain English Summary
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence is a Phase 3 clinical trial sponsored by Stemline Therapeutics, Inc. studying Breast Cancer. This trial tests elacestrant, a new drug, against standard hormone therapies for early-stage breast cancer. It is for women and men with a specific type of early breast cancer (ER+, HER2-, node-positive) that has a high chance of returning. Participants will receive either elacestrant or standard endocrine therapy, and will be randomly assigned to a group. Standard treatments for this condition include various hormone therapies like aromatase inhibitors or tamoxifen. The trial aims to enroll 4220 participants.
Official Summary
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have ER+, HER2- early breast cancer that has spread to lymph nodes and is considered high risk for recurrence. You must have completed at least 24 months but not more than 60 months of prior endocrine therapy (like AIs or tamoxifen), possibly with a CDK 4/6 inhibitor. You cannot join if you have inflammatory breast cancer, a history of other breast cancers, or other specific types of cancer within the last 3 years. You also cannot join if you have had significant interruptions in your prior endocrine therapy or have been off it for more than 6 months before joining. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary goal is to see if elacestrant can prevent breast cancer from returning (invasive breast cancer-free survival) for up to 5 years, meaning it aims to keep the cancer from coming back in the The specific primary outcome measures are: Invasive Breast Cancer-Free Survival (IBCFS) (Up to 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a critical need for more effective treatments for early breast cancer patients at high risk of recurrence, potentially offering a better option than current standard endocrine the As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
Elacestrant represents a novel approach in breast cancer treatment, targeting a significant market of patients with high-risk early-stage disease, with potential for improved outcomes over existing th Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 4220 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if elacestrant is a suitable option for you, considering your specific cancer type and treatment history. Understand that you will be randomly assigned to receive either elacestrant or a standard therapy, and the treatment is open-label, meaning both you and your doctor will know which treatment you are receiving. Participation involves regular visits for treatment, monitoring, and assessments of your health and any side effects over several years. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 4,220 participants
Interventions
- DRUG: Elacestrant — Administered as oral tablets
- DRUG: Anastrozole — Administered as oral tablets
- DRUG: Letrozole — Administered as oral tablets
- DRUG: Exemestane — Administered as oral tablets
- DRUG: Tamoxifen — Administered as oral tablets
Primary Outcomes
- Invasive Breast Cancer-Free Survival (IBCFS) (Up to 5 years)
Secondary Outcomes
- Distant Relapse-Free Survival (DRFS) (Up to 5 years)
- Overall Survival (OS) (Up to 5 years)
- Invasive Disease-Free Survival (IDFS) (Up to 5 years)
- Number of Participants With Adverse Events (AEs) (Up to 5 years plus 28 days)
- Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5)
Full Eligibility Criteria
Key Inclusion Criteria: * Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0, 1+, 2 and in situ hybridization \[ISH\]-negative)\] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines * Participants considered at high risk of recurrence at initial staging * Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) * Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments. Key Exclusion Criteria: * Participants with inflammatory breast cancer * History of any prior (ipsilateral and/or contralateral) invasive breast cancer * Participant with history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix * Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial Locations
- Southern Cancer Center, PC, Daphne, Alabama, United States
- Ironwood Cancer and Research Centers, Chandler, Arizona, United States
- Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
- Mayo Clinic, Scottsdale, Arizona, United States
- Arizona Clinical Research Center, Inc., Tucson, Arizona, United States
- University of Arizona Cancer Center, Tucson, Arizona, United States
- Highlands Oncology Group, PA, Springdale, Arkansas, United States
- Comprehensive Blood & Cancer Center, Bakersfield, California, United States
- UCSF Cancer Center Berkeley, Berkeley, California, United States
- City of Hope National Medical Center, Duarte, California, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06492616?
NCT06492616 is a Phase 3 INTERVENTIONAL study titled "A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence." It is currently recruiting and is sponsored by Stemline Therapeutics, Inc.. The trial targets enrollment of 4220 participants.
What conditions does NCT06492616 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT06492616?
The interventions being studied include: Elacestrant (DRUG), Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), Tamoxifen (DRUG). Administered as oral tablets
What does Phase 3 mean for NCT06492616?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06492616?
This trial is currently "Recruiting." It started on 2024-09-27. The estimated completion date is 2032-10.
Who is sponsoring NCT06492616?
NCT06492616 is sponsored by Stemline Therapeutics, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06492616?
The trial aims to enroll 4220 participants. The trial is currently recruiting and accepting new participants.
How is NCT06492616 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06492616?
The primary outcome measures are: Invasive Breast Cancer-Free Survival (IBCFS) (Up to 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06492616 being conducted?
This trial is being conducted at 20 sites, including Daphne, Alabama; Chandler, Arizona; Gilbert, Arizona; Scottsdale, Arizona and 16 more sites (United States).
Where can I find official information about NCT06492616?
The official record for NCT06492616 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06492616. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06492616 testing in simple terms?
This trial tests elacestrant, a new drug, against standard hormone therapies for early-stage breast cancer. It is for women and men with a specific type of early breast cancer (ER+, HER2-, node-positive) that has a high chance of returning.
Why is this trial significant?
This trial addresses a critical need for more effective treatments for early breast cancer patients at high risk of recurrence, potentially offering a better option than current standard endocrine the As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06492616?
Common side effects may include fatigue, nausea, diarrhea, and hot flashes. Elacestrant can cause eye problems, so regular eye exams will be important. As with any cancer treatment, there is a risk of developing new cancers or experiencing other serious health issues. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06492616?
Ask your doctor if elacestrant is a suitable option for you, considering your specific cancer type and treatment history. Understand that you will be randomly assigned to receive either elacestrant or a standard therapy, and the treatment is open-label, meaning both you and your doctor will know which treatment you are receiving. Participation involves regular visits for treatment, monitoring, and assessments of your health and any side effects over several years. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06492616 signal from an investment perspective?
Elacestrant represents a novel approach in breast cancer treatment, targeting a significant market of patients with high-risk early-stage disease, with potential for improved outcomes over existing th This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will receive either elacestrant or standard endocrine therapy, and will be randomly assigned to a group. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Breast Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.