Skip to main content
PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
Selective Estrogen Receptor Degrader
Imlunestrant
Phase
2
Recruiting
Recruiting Info
A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer (preEMBER)
Related Resources:
preEMBER
Key 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 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
Key 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) >1 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
a
This clinical trial is being conducted globally.
b
Administered orally.
c
Administered subcutaneously.
For information on trial enrollment, locations, and more, call 1-877-285-4559.
REQUEST A MEDICAL SCIENCE LIAISON

or visit www.clinicaltrials.gov for more information on this trial