preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer
New breast cancer drug imlunestrant tested in premenopausal women
Plain English Summary
A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer is a Phase 2 clinical trial sponsored by Eli Lilly and Company studying Breast Neoplasms. This trial tests a new drug called imlunestrant for early-stage breast cancer in premenopausal women. It is for women with estrogen receptor-positive, HER2-negative breast cancer. Participation involves taking imlunestrant, sometimes with another drug to temporarily stop ovarian function, or with tamoxifen. Alternatives include standard endocrine therapies and other breast cancer treatments. The trial aims to enroll 600 participants.
Official Summary
This study will include two groups of patients: Cohort 1 and Cohort 2. Cohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer. Some patients will take both imlunestrant and another treatment to suppress their ovarian function. Some will take it without ovarian suppression. Researchers will compare the effects in breast cancer cells to those of another medicine called tamoxifen. All patients in this group will be premenopausal women who have a type of early breast cancer called estrogen receptor-positive, HER2-negative. The treatment in this group will last for up to 29 days. Cohort 2: will help researchers understand how imlunestrant affects the ovaries when it is taken without ovarian suppression. Researchers will compare the effects to those of another medicine called tamoxifen. This group will also include premenopausal women with the same type of breast cancer. The treatment in this group will last for up to 6 months.
Who Can Participate
Here is what you need to know about eligibility for this trial. Premenopausal women with early-stage ER+, HER2- breast cancer. Must have a specific tumor characteristic (Ki-67 at least 10% for Cohort 1) and good general health. Cannot have had certain prior breast cancer treatments, bilateral oophorectomy, or serious medical conditions. Women of childbearing potential must use effective non-hormonal contraception. This trial is studying Breast Neoplasms, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how the drug affects a marker of cancer cell growth (Ki-67) and the rate of ovarian cysts, indicating how well the drug works and its impact on the ovaries. The specific primary outcome measures are: Change from Baseline in Antigen Kiel (Ki-67) Expression (Baseline, Day 29); Rate of Symptomatic Ovarian Cysts (Up to Day 180). 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 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a need for new treatments for premenopausal women with ER+, HER2- breast cancer, potentially offering a new option beyond current therapies. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Breast Neoplasms, where improved treatment options are needed.
Investor Insight
This Phase 2 trial of imlunestrant, sponsored by Eli Lilly, targets a significant patient population in the breast cancer market, with potential for future development if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval. The large enrollment target of 600 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the specific goals of each cohort and how imlunestrant might affect your menstrual cycle and fertility. Participation may involve regular clinic visits, blood tests, and potentially tumor biopsies. Be prepared to use effective non-hormonal contraception if you are of childbearing potential. 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: 600 participants
Interventions
- DRUG: Imlunestrant — Given orally
- DRUG: Goserelin — Given SC
- DRUG: Tamoxifen 20 mg — Given orally
Primary Outcomes
- Change from Baseline in Antigen Kiel (Ki-67) Expression (Baseline, Day 29)
- Rate of Symptomatic Ovarian Cysts (Up to Day 180)
Secondary Outcomes
- Change from Baseline in Estrogen Receptor (ER) Expression (Baseline, Day 29)
- Change from Baseline in Progesterone Receptor (PR) Expression (Baseline, Day 29)
- Rate of Complex Ovarian Cysts (Up to Day 180)
Full Eligibility Criteria
Inclusion Criteria: Cohort 1: * Have histologically confirmed Stage I to III Estrogen Receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) invasive breast carcinoma with Ki-67 at least 10% * Be willing and able to provide pre- and on-treatment tumor samples. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Be able to swallow capsules or tablets. * Be premenopausal women. * If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol. * Have adequate organ function. Cohort 2: * Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis * Have undergone definitive loco-regional therapy. * Have received at least 4.5 years of any adjuvant endocrine therapy (ET), or at least 2 years of adjuvant ET with no additional ovarian suppression planned. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Be able to swallow capsules or tablets. * Be premenopausal women * If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol. * Have adequate organ function. Exclusion Criteria: Cohort 1: * Have bilateral invasive metastatic, occult primary, or inflammatory breast cancer. * Have had prior bilateral oophorectomy or ovarian ablation. * Have a serious medical condition * Had major surgery within 28 days prior to randomization. * Have a history of other cancer (except non melanoma skin cancer, Stage I uterine cancer, or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year. * Plan to receive concurrent neoadjuvant therapy with any other non-protocol anticancer therapy. * Have had any prior therapy for an invasive or non-invasive breast cancer. * Have had prior radiotherapy to the ipsilateral chest wall for any malignancy. * Have received prior anti-estrogen therapy, including for osteoporosis or prevention of breast cancer. * Have had prior treatment with any Gonadotropin-releasing hormone (GnRH) agonist within 12 months prior to randomization. * Receiving current exogenous reproductive hormone therapy Cohort 2: * Have ovarian cyst(s) greater than (\>) 1 centimeter (cm) at screening. * Have metastatic occult primary, or inflammatory breast cancer. * Have had prior bilateral oophorectomy or ovarian ablation. * Have a serious medical condition * Had major surgery within 28 days prior to randomization. * Have a history of other cancer (except non melanoma skin cancer or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year. * Completed or discontinued prior adjuvant ET \>6 months prior to screening. * Have received prior therapy with any selective estrogen receptor degrader (SERD). * Receiving current exogenous reproductive hormone therapy.
Trial Locations
- Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
- Dana-Farber Cancer Institute, Boston, Massachusetts, United States
- Washington University School of Medicine, St Louis, Missouri, United States
- Tennessee Oncology, Nashville, Tennessee, United States
- University of Texas MD Anderson Cancer Center, Houston, Texas, United States
- Oncology Consultants P.A., Houston, Texas, United States
- Inova Schar Cancer Institute, Fairfax, Virginia, United States
- Cliniques universitaires Saint-Luc, Brussels, Belgium
- Antwerp University Hospital, Edegem, Belgium
- UZ Leuven, Leuven, Belgium
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT07287098?
NCT07287098 is a Phase 2 INTERVENTIONAL study titled "A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer." It is currently not yet recruiting and is sponsored by Eli Lilly and Company. The trial targets enrollment of 600 participants.
What conditions does NCT07287098 study?
This trial investigates treatments for Breast Neoplasms. The primary condition under study is Breast Neoplasms.
What treatments are being tested in NCT07287098?
The interventions being studied include: Imlunestrant (DRUG), Goserelin (DRUG), Tamoxifen 20 mg (DRUG). Given orally
What does Phase 2 mean for NCT07287098?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07287098?
This trial is currently "Not Yet Recruiting." It started on 2026-05. The estimated completion date is 2029-12.
Who is sponsoring NCT07287098?
NCT07287098 is sponsored by Eli Lilly and Company. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07287098?
The trial aims to enroll 600 participants. The trial has not yet started recruiting.
How is NCT07287098 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07287098?
The primary outcome measures are: Change from Baseline in Antigen Kiel (Ki-67) Expression (Baseline, Day 29); Rate of Symptomatic Ovarian Cysts (Up to Day 180). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07287098 being conducted?
This trial is being conducted at 20 sites, including Indianapolis, Indiana; Boston, Massachusetts; St Louis, Missouri; Nashville, Tennessee and 16 more sites (United States, Belgium, France).
Where can I find official information about NCT07287098?
The official record for NCT07287098 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07287098. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07287098 testing in simple terms?
This trial tests a new drug called imlunestrant for early-stage breast cancer in premenopausal women. It is for women with estrogen receptor-positive, HER2-negative breast cancer.
Why is this trial significant?
This trial addresses a need for new treatments for premenopausal women with ER+, HER2- breast cancer, potentially offering a new option beyond current therapies.
What are the potential risks of participating in NCT07287098?
Potential side effects include those related to hormonal changes, such as hot flashes or changes in menstrual cycle. Ovarian cysts are being monitored as a potential side effect. Other common side effects may include fatigue, nausea, and headache. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07287098?
Ask your doctor about the specific goals of each cohort and how imlunestrant might affect your menstrual cycle and fertility. Participation may involve regular clinic visits, blood tests, and potentially tumor biopsies. Be prepared to use effective non-hormonal contraception if you are of childbearing potential. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07287098 signal from an investment perspective?
This Phase 2 trial of imlunestrant, sponsored by Eli Lilly, targets a significant patient population in the breast cancer market, with potential for future development if successful. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participation involves taking imlunestrant, sometimes with another drug to temporarily stop ovarian function, or with tamoxifen. 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 Neoplasms Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.