No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
4,220 (estimated)
Sponsor
Stemline Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for women and men with early breast cancer that has a high risk of coming back. Participants will compare the effects of elacestrant with standard treatment after being on another therapy for a while.
Are You a Good Fit for This Trial?
You may be able to join if
I have ER-positive, HER2-negative early breast cancer.
I am considered at high risk of my cancer coming back.
I have been on endocrine therapy for at least 24 months but not more than 60 months.
I have completed or stopped any CDK4/6 inhibitors or PARP inhibitors.
You may not be able to join if
I have inflammatory breast cancer.
I have a history of invasive breast cancer.
I have had any other cancer in the past 3 years, except for certain skin or bladder cancers.
I have had a break of more than 6 months from my previous cancer treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
Eligibility Criteria
Key Inclusion Criteria:
* Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry \[IHC\]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization \[ISH\]-negative \[not amplified\]). ISH-negative without IHC testing will also be eligible on tumor biopsy…
Key Inclusion Criteria:
* Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry \[IHC\]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization \[ISH\]-negative \[not amplified\]). ISH-negative without IHC testing will also be eligible 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/College of American Pathologists guidelines.
* Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria:
1. ≥4 positive axillary lymph nodes or
2. 1-3 positive axillary lymph nodes and
1. Histologic grade 3 disease and/or
2. Tumor size ≥5 centimeters and/or
3. High genomic risk (identified by Oncotype, MammaPrint, EndoPredict, PAM50)
* Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 \[C1D1\]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist.
* Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase 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 non-breast 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.
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