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
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.
Ready to participate?
Review the details below, then apply to join this clinical trial.
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.
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.
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 …
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.
Trial Locations
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Status
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…
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.
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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