{"id":4833,"date":"2024-08-09T11:59:55","date_gmt":"2024-08-09T09:59:55","guid":{"rendered":"https:\/\/studienportal-brustkrebs.de\/ember-4\/"},"modified":"2025-07-30T11:44:12","modified_gmt":"2025-07-30T09:44:12","slug":"ember-4","status":"publish","type":"post","link":"https:\/\/studienportal-brustkrebs.de\/en\/ember-4\/","title":{"rendered":"EMBER-4"},"content":{"rendered":"\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

EMBER-4 Study<\/strong><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Endocrine therapy with Imlunestrant in high-risk patients
with early ER-positive and HER2-negative breast cancer and
completed endocrine therapy<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

EMBER-4 is a randomized, unblinded (patients and physicians know the treatment arm at the start of the study) Phase 3 therapy study comparing two endocrine therapies in patients with early estrogen receptor-positive (ER+), HER2-receptor-negative (HER2-) breast cancer who have an increased risk of disease recurrence and who have previously received 2 to 5 years of endocrine therapy after surgery.<\/p>

What is being investigated in this study?<\/strong><\/p>

Breast cancer is diagnosed in most patients at an early stage of the disease. Currently, the standard treatment is surgery followed by endocrine therapy, administered for 5 to 10 years, if the tumor has the following characteristics: early stage, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative (HER2-). If patients have a high risk of recurrence, Abemaciclib<\/em> (a drug with an inhibitor for a specific protein significantly involved in cell division) can additionally be administered in combination during the first two years. Despite the current standard treatment, a significant proportion of patients experience disease recurrence. Consequently, there is a need to further optimize post-operative treatment and prevent disease recurrence, especially in those patients who have an increased risk of such recurrence. The risk for these patients to develop distant recurrence after 5 years of endocrine therapy depends on the clinico-pathological features at diagnosis, i.e., tumor size, grade, and nodal status. <\/p>

Imlunestrant<\/em> belongs to the so-called targeted estrogen receptor degraders. Active substances of this drug class promote the degradation of estrogen receptors on the surface of tumors and thus inhibit their estrogen-dependent growth. Previous studies have indicated that Imlunestrant<\/em> can specifically stop the cell division of tumor cells, provided the tumor is estrogen receptor-positive. <\/p>

What is the goal of the study?<\/strong><\/p>

The primary goal of this study is to demonstrate that treatment with Imlunestrant<\/em> has a benefit in efficacy compared to current standard anti-hormone therapy. The study targets patients with an increased risk of disease recurrence, whose tumor is estrogen receptor-positive and HER2-receptor negative, and who have also previously received standard anti-hormone therapy for 2-5 years. Furthermore, the safety and tolerability of the treatments and the quality of life during therapy will be investigated. <\/p>

How is the study conducted?<\/strong><\/p>

Within the study, there are two treatment arms to which patients are randomly assigned in a 1:1 ratio:<\/p>

Arm 1:
Imlunestrant<\/em> \u2013 oral intake for approx. 5 years<\/p>

Arm 2:
Tamoxifen<\/em> or Aromatase Inhibitor (as decided by the treating physicians) – for approx. 5 years<\/p>

Follow-up for both arms: 5 years<\/p>

Are there risks?<\/strong><\/p>

You will be informed about possible risks or side effects associated with participation during an informational discussion.<\/p>

Eligibility requirements<\/strong><\/p>

Men and women aged 18 and older can participate in this study, with:<\/p>