Health Trials

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

ConditionBreast Neoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEli Lilly and Company

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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Imlunestrant

    Drug

    Given orally

  • Goserelin

    Drug

    Given SC

  • Tamoxifen 20 mg

    Drug

    Given orally

Treatment groups

600 Participants
are divided into 5 treatment groups
Group A: Cohort 1 Arm AExperimental treatment 1 intervention
Group B: Cohort 1 Arm B - Imlunestrant + GoserelinExperimental treatment 2 interventions
Group C: Cohort 1 Arm C - TamoxifenActive comparator 1 intervention
Group D: Cohort 2 Arm A - ImlunestrantExperimental treatment 1 intervention
Group E: Cohort 2 Arm B - TamoxifenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Antigen Kiel (Ki-67) Expression

Time frame
Baseline, Day 29
2

Rate of Symptomatic Ovarian Cysts

Time frame
Up to Day 180

Secondary outcomes

1

Change from Baseline in Estrogen Receptor (ER) Expression

Time frame
Baseline, Day 29
2

Change from Baseline in Progesterone Receptor (PR) Expression

Time frame
Baseline, Day 29
3

Rate of Complex Ovarian Cysts

Time frame
Up to Day 180

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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