A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)

Overview

About this study

The purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without
evidence of distant metastasis.

- Participants must have received at least 24 months but not more than 60 months of any
adjuvant ET, from time of adjuvant ET initiation.

- Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy
with a CDK4/6- or PARP- inhibitor.

- Must have an increased risk of disease recurrence based on clinical-pathological risk
features.

- Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.

- Have adequate organ function.

Exclusion Criteria:

- Have any evidence of metastatic disease (including contralateral ALN) or inflammatory
breast cancer at primary breast cancer diagnosis.

- Participants with more than a 6-month consecutive gap in therapy during the course of
prior adjuvant ET.

- Participants who have completed or discontinued prior adjuvant ET >6 months prior to
screening.

- Participants with a history of previous breast cancer are excluded, with the exception
of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.

- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 180 days
after the last dose of study intervention.

- Participant has previously received ET of any duration for breast cancer prevention
(tamoxifen or AIs) or raloxifene.

- Participants with a history of any other cancer.

- Have serious preexisting medical conditions that, in the judgment of the investigator,
would preclude participation in this study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/20/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Rohit Rao, M.B.B.S., M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Karthik Giridhar, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Brenda Ernst, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available