- European Organization for Research and Treatment of Cancer and Menarini Group launch new clinical trial on early-stage breast cancer
BRUSSELS and FLORENCE, Italy, Oct. 19, 2023 /PRNewswire/ -- The European Organization for Research and Treatment of Cancer (EORTC) and Menarini Group (Menarini), a leading international pharmaceutical and diagnostics company, today announced that it has launched a new study for breast cancer patients: EORTC 2129-BCG TREAT ctDNA, a clinical trial supported by EORTC Breast Cancer Group. Menarini and its subsidiary, Stemline, will provide elacestrant. A molecular residual disease (MRD) test will also be used for the detection of circulating tumor DNA (ctDNA). The study was presented under the new Clinical Trials Regulations and the activation process is expected to begin in the fourth quarter of 2023.
ORSERDU® (elacestrant) was approved by the European Commission in September 2023 as monotherapy for the treatment of postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer (CBC), with a activating ESR1 mutation that has disease progression after at least one line of endocrine therapy including a CDK4/6 inhibitor.
"We are excited to offer our high-risk ER/HER2- ctDNA-positive early-stage breast cancer patients the opportunity to participate in the Treat ctDNA trial. Patients who are ctDNA-positive will be identified through a customized assay. Our goal is study the value of the new selective estrogen receptor degrader (SERD), elacestrant, in reducing the rate of late distant relapses in these patients," said Professor Michail Ignatiadis, Chair of the EORTC Breast Cancer Group and Director of the Medical Oncology Clinic of Breast and Program at the Jules Bordet Institut.
This intergroup trial, managed by the EORTC Breast Cancer Group, will be carried out jointly with several national and international cancer clinical research groups, including the German SUCCESS group under the umbrella of BIG (Breast International Group). Twelve countries have been selected to participate in the trial (Italy, France, Belgium, Spain, Ireland, Cyprus, Germany, Greece, Netherlands, Portugal, Sweden and Switzerland) and more than 120 sites are expected to screen approximately 1,960 patients. The phase III, randomized, open-label, superiority trial will evaluate whether elacestrant can delay the onset of metastasis or death compared to standard adjuvant endocrine therapy in patients with early-stage ER/HER2- breast cancer and molecular relapse.
"Menarini Group is pleased to partner with EORTC on this important study to expand our understanding of how elacestrant can potentially benefit ER/HER2- patients with early-stage breast cancer," said Elcin Barker Ergun, CEO of Menarini Group. "Evaluating new treatments with a manageable safety profile, such as elacestrant, is important as we look for new options for this population."
After verifying that patients meet eligibility criteria, they will enter the ctDNA screening phase of the study, in which plasma samples will be collected and analyzed for the presence of ctDNA. Testing will be performed every six months from study entry until the end of accrual. Patients with a positive ctDNA test, who do not have metastases and who meet the eligibility criteria, will be randomly assigned to the standard endocrine treatment group (the same treatment they were receiving before ctDNA detection) or the endocrine treatment group. elacestrant. Patients will be randomly assigned to one of the two treatment arms within four weeks of receiving test results, with the goal of randomizing 110 patients to each arm. Patients in both the control and experimental groups will benefit from timely detection of macroscopic disease relapse.
About elacestrant (ORSERDU®)
European Union Indication: ORSERDU (elacestrant) monotherapy is indicated for the treatment of postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, metastatic or locally advanced breast cancer with an activating mutation of ESR1 that have disease progression following at least one line of endocrine therapy that includes a CDK4/6 inhibitor.
ORSERDU SmPC Important Safety Information
Hepatic Impairment: ORSERDU should be administered with caution at a dose of 258 mg once daily in patients with moderate hepatic impairment (Child-Pugh B). In the absence of clinical data, ORSERDU is not recommended in patients with severe hepatic impairment (Child-Pugh C).
Concomitant use with CYP3A4 inducers and/or inhibitors: Concomitant use of strong or moderate CYP3A4 inhibitors should be avoided with ORSERDU. Concomitant use of strong or moderate CYP3A4 inducers with ORSERDU should be avoided.
Thromboembolic events: Thromboembolic events are commonly seen in patients with advanced breast cancer and have been observed in clinical studies with ORSERDU. This should be taken into account when prescribing ORSERDU to patients at risk.
Adverse reactions:
Serious adverse reactions reported in ≥ 1% of patients included nausea, dyspnea, and thromboembolism (venous).
The most common adverse reactions (≥ 10%) with ORSERDU were nausea, increased triglycerides, increased cholesterol, vomiting, fatigue, dyspepsia, diarrhea, decreased calcium, back pain, increased creatinine, arthralgia, decreased sodium, constipation, headache, hot flashes, abdominal pain, anemia, decreased potassium and increased alanine aminotransferase.
The most common Grade ≥3 (≥2%) adverse reactions of elacestrant were nausea (2.7%), increased AST (2.7%), increased ALT (2.3%), anemia (2%). , back pain (2%) and bone pain (2%).
Nausea: Nausea was reported in 35% of patients. Grade 3-4 nausea episodes were reported in 2.5% of patients. Nausea occurred most frequently in the first cycle and from cycle 2 onward, the incidence of nausea was generally lower in subsequent cycles (i.e., over time).
Elderly: Gastrointestinal disorders were reported more frequently in patients ≥ 75 years of age.
ORSERDU should not be used during pregnancy or in women of childbearing potential who are not using contraceptive methods. Based on the mechanism of action of elacestrant and findings from reproductive toxicity studies in animals, ORSERDU may cause fetal harm when administered to pregnant women. Women of childbearing potential should be advised to use effective contraception during treatment with ORSERDU and for one week after the last dose.
It is recommended that lactating women do not breastfeed during treatment with ORSERDU and for one week after the last dose of ORSERDU.
Based on findings from animal studies and its mechanism of action, ORSERDU may affect fertility in women and men of reproductive potential.
Effects on the ability to drive and use machines: Fatigue, asthenia and insomnia have been reported in some patients taking ORSERDU. Patients who experience such adverse reactions while driving or using machinery should use caution.
The safety and effectiveness of ORSERDU in children from birth to 18 years of age have not been established.
To report SUSPECTED ADVERSE REACTIONS: EUPV@menarinistemline.com
To file a complaint about a product: EUcustomerservice@menarinistemline.com
To request medical information: EUmedinfo@menarinistemline.com
Elacestrant is also being investigated in several clinical trials in metastatic breast cancer, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108); and ELCIN (NCT05596409). It is also planned to evaluate elacestrant in early breast cancer disease.
Menarini Group obtained global licensing rights to elacestrant in July 2020 from Radius Health, Inc. Menarini Group is now fully responsible for the global registration, commercialization and further development activities of elacestrant.
Acerca de EORTC Breast Cancer Group
The EORTC Breast Cancer Group (BCG) is a group of Europe's leading academic hospitals that aims to develop new standards of care for breast cancer patients through innovation. Our research focus is the evaluation of innovative treatments and multidisciplinary approaches to increase survival and improve quality of life for all breast cancer patients.
About Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of more than $4.4 billion and more than 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetes, inflammation and analgesia. With 18 production sites and 9 research and development centers, Menarini products are available in 140 countries worldwide. For more information, visit www.menarini.com.
About Stemline
Stemline, a wholly owned subsidiary of Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapies. Stemline markets ORSERDU® (elacestrant) in the United States and the EU, an oral endocrine therapy indicated for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative postmenopausal women or adult men. , ESR1 mutated, advanced or metastatic breast cancer with disease progression after at least one line of endocrine therapy. Stemline also markets ELZONRIS® (tagraxofusp-erzs), a novel CD123-targeted treatment for patients with blastic plasmacytoid dendritic cell neoplasia (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in United States and the EU to date. Stemline also markets NEXPOVIO®, an XPO1 inhibitor for multiple myeloma, in Europe. Stemline also has an extensive clinical portfolio of small molecules and biologics in various stages of development for a variety of solid and hematologic cancers.
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