Imlunestrant for Early Estrogen Receptor-Positive Breast Cancer

A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer

Recruiting Phase 2 Interventional Study
Breast Neoplasms
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for premenopausal women with a specific type of early breast cancer. Participants will take a treatment called imlunestrant for either 29 days or up to 6 months, depending on the group they join.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a premenopausal woman.
  • I have been diagnosed with estrogen receptor-positive, HER2-negative early breast cancer.
  • I am able to swallow capsules or tablets.
  • I have a good performance status.
  • I am willing to provide tumor samples.
  • I have adequate organ function.
  • I have received a certain amount of prior treatment for my cancer.

You may not be able to join if

  • I have had major surgery in the last 28 days.
  • I have another serious medical condition.
  • I have a history of certain other cancers unless in complete remission for at least 1 year.
  • I have had prior treatment for an invasive or non-invasive breast cancer.
  • I am currently taking reproductive hormone therapy.
  • I have ovarian cysts larger than 1 cm.
  • I have had prior bilateral oophorectomy or ovarian ablation.

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.

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About This Trial
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 …
Trial Locations
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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…
Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT