Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Start Date27 Sep 2024

Sponsor / Collaborator

Stemline Therapeutics, Inc.

NCT06382948 / Not yet recruitingPhase 3

A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ER+/HER2-, ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK4/6 Inhibitors

This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.
The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.
Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.

Start Date01 Sep 2024

Sponsor / Collaborator

Medica Scientia Innovation Research SL

[+1]

100 Clinical Results associated with Elacestrant hydrochloride

100 Translational Medicine associated with Elacestrant hydrochloride

100 Patents (Medical) associated with Elacestrant hydrochloride

Literatures (Medical) associated with Elacestrant hydrochloride

01 Dec 2024·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery of non-antiproliferative selective estrogen receptor degraders (SERDs) based on scaffold optimization of elacestrant

Article

Author: Liu, Wukun ; Chen, Xuejie ; Zhao, Zhihao ; Liu, Lijuan ; Wang, Shanglong ; Zheng, Tianpeng ; Lu, Yunlong ; Zhu, Yuqing

Elacestrant, the first oral selective estrogen receptor degrader (SERD), has been approved for ER positive breast cancer in 2023. Recent study showed that elacestrant has moderate pharmacokinetic property and the oral bioavailability is 11 %. In this study, we have performed docking analyses of elacestrant with different cytochrome P450 isoforms. The results indicated that tetrahydronaphthalene scaffold of elacestrant located closely to Heme iron center of P450s and might undergo rapid metabolism by CYP3A4. Therefore, we have changed the tertiary carbon atom to nitrogen atom of the scaffold to attenuate the metabolic effect. The most interesting finding is that compound B16 exhibited significant degradation of ERα at 5 μM but didn't show antiproliferative activity at high concentrations in MCF-7 and T47D cells. Compound B16 may serve as an ER probe to investigate ER status in ER positive breast cancer cells.

01 Nov 2024·CANCER TREATMENT REVIEWS

Oral SERDs changing the scenery in hormone receptor positive breast cancer, a comprehensive review

Review

Author: Gheysen, Mathilde ; Neven, Patrick ; Wildiers, Hans ; Punie, Kevin

BACKGROUND:

Primary and acquired endocrine resistance remains a major issue in the treatment of hormone receptor positive breast cancer. Acquired resistance often results from estrogen receptor 1 (ESR1) mutations leading to estrogen independent estrogen receptor activation. Selective estrogen receptor degraders (SERDs) induce degradation of this receptor, thereby overcoming this resistance. The intramuscular administration and modest efficacy of fulvestrant, the first SERD, triggered development of oral, more potent SERDs. This narrative review gives an overview of the current evidence regarding this new drug class.

METHODS:

Medline/PubMed and Embase database were screened using a systematic search strategy. We assessed the San Antonio Breast Cancer Symposium abstract reports, the European Society of Medical Oncology (ESMO) and American Society of Clinical Oncology (ASCO) meeting resources by applying the following terms: 'SERD', 'giredestrant', 'elacestrant', 'imlunestrant', 'amcenestrant', 'camizestrant' and 'rintodestrant'.

CLINICALTRIALS:

gov was consulted to include ongoing trials.

RESULTS:

The search retrieved 1191 articles. After screening, 108 articles were retained. In the phase 3 EMERALD trial, elacestrant demonstrated benefit in progression free survival (PFS) in second line metastatic disease in postmenopausal women or men, leading to Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval for the ESR1 mutated population. This PFS advantage was more pronounced among patients who had priorly received at least 12 months of a cyclin-dependent kinases 4/6 inhibitor (CDK4/6i). In the phase 2 SERENA-2 trial, camizestrant improved PFS as second line treatment. However, trials of giredestrant and amcenestrant failed to show PFS benefit in second line metastatic setting. In the preoperative setting, several oral SERDs resulted in a significant reduction of tumoral proliferation. Furthermore, many trials are still in progress.

CONCLUSION:

Oral SERDs constitute an exciting new drug class. Ongoing and future research will further refine the role of these drugs next to standard endocrine treatments and targeted therapies.

01 Nov 2024·CURRENT OPINION IN ONCOLOGY

Endocrine therapy for early breast cancer in the era of oral selective estrogen receptor degraders: challenges and future perspectives

Review

Author: Castellano, Grazia ; Zagami, Paola ; Curigliano, Giuseppe ; Ascione, Liliana

Purpose of review:

Growth and survival of hormone receptor positive breast cancer cells are dependent on circulating hormones (e.g., estrogen and progesterone). Endocrine therapy improved outcomes in both early and advanced hormone receptor positive breast cancer. These treatments include drugs with different mechanisms of action, namely selective estrogen receptor modulators (SERM), aromatase inhibitors, and selective estrogen receptor degraders (SERDs). SERDs represent estrogen receptor antagonists, favoring its degradation and thus interfering with proliferation genes transcription and activation. Fulvestrant is the first approved SERD, administered intramuscularly for treating advanced breast cancer.

Recent findings:

Oral SERDs have been tested to overcome the limitation of the intramuscular administration, and to increase SERD bioavailability. Recently, an oral SERD, Elacestrant, has been approved by the Food and Drug Administration (FDA) for patients carrying an ESR1 mutation. In fact, oral SERDs seem to be effective in tumors harboring ESR1 mutations, a well known mechanism of resistance to endocrine therapy (especially aromatase inhibitors).

Summary:

More recently, oral SERDs have been tested in patients with early hormone receptor positive breast cancer, although their impact on survival and in this curative setting compared to standard endocrine therapy still needs to be elucidated. The best timing and duration of SERD administration and specific biomarkers in (neo)adjuvant setting remain largely unknown.

105

News (Medical) associated with Elacestrant hydrochloride

09 Sep 2024

·www.businesswire.com

Natera to Present New Signatera™ Colorectal Cancer Data at ESMO Showing 10X Advantage in Overall Survival

AUSTIN, Texas--( BUSINESS WIRE )-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced it will present new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, at the 2024 European Society for Medical Oncology (ESMO) Congress taking place Sept. 13-16 in Barcelona, Spain. Natera and its collaborators will present a total of nine abstracts, including five poster presentations from the GALAXY observational arm of the CIRCULATE-Japan trial, one of the largest and most comprehensive prospective studies of MRD testing in resectable colorectal cancer (CRC). The GALAXY data includes an updated analysis of more than 2,100 patients with stage I-IV CRC, reporting 36-month disease-free survival (DFS), and, for the first time, overall survival (OS). Key highlights include: Signatera-positive patients had significantly shorter OS compared to those who were Signatera-negative (hazard ratio of ~10), suggesting that Signatera-negative patients had an almost 10-fold advantage in OS. This compares favorably to all known guideline recommended biomarkers that typically have hazard ratios for overall survival in the 1-4 range. Overall survival stratified by adjuvant chemotherapy (ACT) will also be presented. This will build on prior GALAXY DFS data which has shown significant benefit of ACT in Signatera-positive patients, but lack of benefit in Signatera-negative patients. The current standard of care is based on studies showing that most CRC patients derive a small ~0-5% absolute and ~10-20% relative OS benefit from ACT. Identifying subgroups where this benefit is concentrated is critical for advancing clinical management of early-stage CRC. “ ESMO 2024 will showcase some of our most impactful data in colorectal cancer to-date,” said Minetta Liu, MD, chief medical officer of oncology at Natera. “ Notably, we will present an updated analysis from the GALAXY arm of CIRCULATE-Japan with the first prospective read-out of overall survival based on MRD. These findings underscore the potential for Signatera to predict long-term outcomes.” Other presentations at ESMO will highlight new Signatera data in breast cancer and squamous cell carcinoma of the head and neck. Below is the full list of presentations: Presentation Highlights Poster Presentation #553P | CRC | Sept. 16 | Presenter: Jun Nagata, MD Association of ctDNA-based MRD detection and MRD clearance with short-term overall survival in patients with resectable colorectal cancer: Updated analysis of CIRCULATE-Japan GALAXY Poster Presentation #558P | CRC | Sept. 16 | Presenter: Kozo Kataoka, MD, PhD Survival benefit of adjuvant chemotherapy based on molecular residual disease detection in resected colorectal liver metastases; subgroup analysis from CIRCULATE-Japan GALAXY Oral Presentation and Additional Presentations Oral Presentation | CRC | Presenter: Myriam Chalabi, MD Sept. 15, 09:10 - 09:20 Neoadjuvant immunotherapy in locally advanced MMR-deficient (dMMR) colon cancer (CC): 3-year disease-free survival (DFS) from NICHE-2 Poster Presentation #923P | SCCHN | Sept. 14 | Presenter: Natasha Honoré, MD, PhD Tumor-informed ctDNA assay to predict recurrence in locally advanced SCCHN Poster Presentation #555P | CRC | Sept. 16 | Presenter: Tomoya Harima, MD Association Between Copy Number Aberration and ctDNA MRD in Colorectal Cancer: CIRCULATE-Japan GALAXY Poster Presentation #554P | CRC | Sept. 16 | Presenter: Yoshiaki Nakamura, MD, PhD Novel Clinical Decision Support (CDS) System Optimizing Adjuvant Chemotherapy (ACT) for Colorectal Cancer (CRC) by Integrating Deep Learning and circulating tumor DNA (ctDNA) molecular residual disease (MRD): GALAXY Histotyping Poster Presentation #545P | CRC | Sept. 16 | Presenter: Chiara M. Loeffler, MD HIBRID: Histology and ct-DNA based Risk-stratification with Deep Learning Poster Presentation #338TiP | Breast Cancer | Sept. 16 | Presenter: Michail Ignatiadis, MD, PhD EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA) Poster Presentation #314P | Breast Cancer | Sept. 16 | Presenter: Mark Magbanua, PhD The impact of changes in tumor mutational landscape during neoadjuvant therapy on tumor-informed ctDNA testing in breast cancer patients About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 70 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 200 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov .

Clinical StudyImmunotherapyClinical Result

17 Jul 2024

·pipelinereview.com

Biotheryx Announces First Patient Dosed in Phase 1 Clinical Trial of BTX-9341, a First-in-Class, Dual Bifunctional Degrader of CDK4/6, as a Monotherapy and in Combination

SAN DIEGO, CA, USA I July 17, 2024 I Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory diseases, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating BTX-9341, an investigational oral and bifunctional degrader of cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6), as a monotherapy and in combination with fulvestrant for patients with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have previously received CDK4/6 inhibitor therapy either in the adjuvant or metastatic setting. “BTX-9341 is a potent and selective CDK4/6 degrader that has shown significant anti-tumor activity in both CDK4/6 inhibitor naïve and resistant preclinical models. We are optimistic that it will meet a critical unmet medical need for patients with HR+/HER2- breast cancer who have received prior CDK4/6 inhibitor therapy,” said Leah Fung, Ph.D., CEO of Biotheryx. “Dosing the first patient in this trial represents a significant milestone for Biotheryx, the patients we aim to serve and the scientists who have made this possible.” The Phase 1 clinical trial will begin with dose escalation of BTX-9341 as a monotherapy, followed by a combination with fulvestrant and will conclude with dose expansion of BTX-9341 in combination with fulvestrant. The trial will assess safety, tolerability, pharmacokinetic and pharmacodynamic activity of BTX-9341 as a monotherapy and in combination with fulvestrant. Once the recommended Phase 2 dose of the combination has been determined, there will be a formal evaluation of efficacy in an expansion cohort. “We are thrilled to have dosed the first patient with BTX-9341 at The START Center for Cancer Research,” stated START Co-Founder and Co-Director of Clinical Research, Dr. Amita Patnaik, MD, FRCPC. “BTX-9341 is a highly novel, first-in-class, potent and selective degrader of CDK4/6, representing an innovative therapeutic approach. It has the potential to transform the care of patients with advanced and/or metastatic HR+/HER2- breast cancer, particularly those who have received prior CDK4/6 inhibitor therapies. This milestone is perfectly aligned with START’s mission to accelerate drug development and provide early access to cutting-edge anticancer therapies, bringing hope to patients and their families.” In preclinical studies, orally administered BTX-9341 demonstrated in vivo CDK4/6 degradation and improved anti-tumor activity as a monotherapy compared to current standard of care treatment regimens. BTX-9341 also demonstrated synergies with selective estrogen receptor degraders including fulvestrant, elacestrant and camizestrant in CDK4/6 naïve and resistant models. About BTX-9341 BTX-9341 is a first-in-class, oral degrader of CDK4/6, important targets for a range of cancers and clinically validated in HR+/HER2- breast cancer. In preclinical breast cancer models, BTX-9341 demonstrated superiority to CDK4/6 inhibitors through potent and highly selective catalytic degradation of CDK4 and CDK6, robust inhibition of Cyclin E and CDK2 transcription, cell cycle arrest and ultimately superior in vivo efficacy in breast cancer xenografts. Beyond this increased efficacy potential, BTX-9341 is differentiated from CDK4/6 inhibitor approaches through the ability to overcome key resistance mechanisms that limit the impact of inhibitors in second line HR+/HER2- breast cancer. About Biotheryx, Inc. Biotheryx is a clinical-stage biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders, including bifunctional degraders and molecular glues. Our focus is on deploying the differentiated potential of degraders towards validated targets in cancer and inflammatory disease. Members of our founding and scientific teams previously developed the IMiDs, the first U.S. Food and Drug Administration (FDA) approved modulators of Cereblon, the most widely validated E3 ligase involved in protein degradation, and we have applied our expertise in Cereblon binding to build our proprietary PRODEGY platform. Biotheryx’s clinical program, BTX-9341, a bifunctional degrader of CDK4 and CDK6, began a Phase 1 clinical trial in the third quarter of 2024. Biotheryx’s pipeline also includes BTX-10908, a first-in-class degrader of SOS1 for pan-KRAS mutant cancers and PDE4 degraders for inflammatory diseases. For more information, please visit biotheryx.com and engage with us on LinkedIn . SOURCE: Biotheryx

Phase 1PROTACs

17 Jul 2024

·www.prnewswire.com

Biotheryx Announces First Patient Dosed in Phase 1 Clinical Trial of BTX-9341, a First-in-Class, Dual Bifunctional Degrader of CDK4/6, as a Monotherapy and in Combination with Fulvestrant for HR+/HER2- Breast Cancer

SAN DIEGO, July 17, 2024 /PRNewswire/ -- Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory diseases, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating BTX-9341, an investigational oral and bifunctional degrader of cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6), as a monotherapy and in combination with fulvestrant for patients with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have previously received CDK4/6 inhibitor therapy either in the adjuvant or metastatic setting. "BTX-9341 is a potent and selective CDK4/6 degrader that has shown significant anti-tumor activity in both CDK4/6 inhibitor naïve and resistant preclinical models. We are optimistic that it will meet a critical unmet medical need for patients with HR+/HER2- breast cancer who have received prior CDK4/6 inhibitor therapy," said Leah Fung, Ph.D., CEO of Biotheryx. "Dosing the first patient in this trial represents a significant milestone for Biotheryx, the patients we aim to serve and the scientists who have made this possible." The Phase 1 clinical trial will begin with dose escalation of BTX-9341 as a monotherapy, followed by a combination with fulvestrant and will conclude with dose expansion of BTX-9341 in combination with fulvestrant. The trial will assess safety, tolerability, pharmacokinetic and pharmacodynamic activity of BTX-9341 as a monotherapy and in combination with fulvestrant. Once the recommended Phase 2 dose of the combination has been determined, there will be a formal evaluation of efficacy in an expansion cohort. "We are thrilled to have dosed the first patient with BTX-9341 at The START Center for Cancer Research," stated START Co-Founder and Co-Director of Clinical Research, Dr. Amita Patnaik, MD, FRCPC. "BTX-9341 is a highly novel, first-in-class, potent and selective degrader of CDK4/6, representing an innovative therapeutic approach. It has the potential to transform the care of patients with advanced and/or metastatic HR+/HER2- breast cancer, particularly those who have received prior CDK4/6 inhibitor therapies. This milestone is perfectly aligned with START's mission to accelerate drug development and provide early access to cutting-edge anticancer therapies, bringing hope to patients and their families." In preclinical studies, orally administered BTX-9341 demonstrated in vivo CDK4/6 degradation and improved anti-tumor activity as a monotherapy compared to current standard of care treatment regimens. BTX-9341 also demonstrated synergies with selective estrogen receptor degraders including fulvestrant, elacestrant and camizestrant in CDK4/6 naïve and resistant models. About BTX-9341 BTX-9341 is a first-in-class, oral degrader of CDK4/6, important targets for a range of cancers and clinically validated in HR+/HER2- breast cancer. In preclinical breast cancer models, BTX-9341 demonstrated superiority to CDK4/6 inhibitors through potent and highly selective catalytic degradation of CDK4 and CDK6, robust inhibition of Cyclin E and CDK2 transcription, cell cycle arrest and ultimately superior in vivo efficacy in breast cancer xenografts. Beyond this increased efficacy potential, BTX-9341 is differentiated from CDK4/6 inhibitor approaches through the ability to overcome key resistance mechanisms that limit the impact of inhibitors in second line HR+/HER2- breast cancer. About Biotheryx, Inc. Biotheryx is a clinical-stage biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders, including bifunctional degraders and molecular glues. Our focus is on deploying the differentiated potential of degraders towards validated targets in cancer and inflammatory disease. Members of our founding and scientific teams previously developed the IMiDs, the first U.S. Food and Drug Administration (FDA) approved modulators of Cereblon, the most widely validated E3 ligase involved in protein degradation, and we have applied our expertise in Cereblon binding to build our proprietary PRODEGY platform. Biotheryx's clinical program, BTX-9341, a bifunctional degrader of CDK4 and CDK6, began a Phase 1 clinical trial in the third quarter of 2024. Biotheryx's pipeline also includes BTX-10908, a first-in-class degrader of SOS1 for pan-KRAS mutant cancers and PDE4 degraders for inflammatory diseases. For more information, please visit biotheryx.com and engage with us on LinkedIn. SOURCE Biotheryx, Inc.

Phase 1PROTACs

100 Deals associated with Elacestrant hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11671	Elacestrant hydrochloride	-	DB06374

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced breast cancer	GB	Stemline Therapeutics, Inc.	05 Jan 2024
Metastatic breast cancer	GB	Stemline Therapeutics, Inc.	05 Jan 2024
ER-positive/HER2-negative/ ESR1-mutated breast cancer	US	Stemline Therapeutics, Inc.	27 Jan 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	NDA/BLA	US	Radius Pharmaceuticals, Inc.	22 Jun 2022
Node-positive breast cancer	Phase 3	US	Stemline Therapeutics, Inc.	27 Sep 2024
Estrogen receptor positive breast cancer	Phase 3	BE	A. Menarini Industrie Farmaceutiche Riunite SRL	15 Dec 2023
Estrogen receptor positive breast cancer	Phase 3	FR	A. Menarini Industrie Farmaceutiche Riunite SRL	15 Dec 2023
Estrogen receptor positive breast cancer	Phase 3	DE	A. Menarini Industrie Farmaceutiche Riunite SRL	15 Dec 2023
Estrogen receptor positive breast cancer	Phase 3	IE	A. Menarini Industrie Farmaceutiche Riunite SRL	15 Dec 2023
Estrogen receptor positive breast cancer	Phase 3	IT	A. Menarini Industrie Farmaceutiche Riunite SRL	15 Dec 2023
HER2-negative breast cancer	Phase 3	BE	A. Menarini Industrie Farmaceutiche Riunite SRL	15 Dec 2023
HER2-negative breast cancer	Phase 3	FR	A. Menarini Industrie Farmaceutiche Riunite SRL	15 Dec 2023
HER2-negative breast cancer	Phase 3	DE	A. Menarini Industrie Farmaceutiche Riunite SRL	15 Dec 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05563220 (ELEVATE, ESMO2024)	Phase 1/2	ER-positive/HER2-negative Breast Cancer ER+ \| HER2-negative \| ESR1-mut	-	Elacestrant + Everolimus	ywplddrxud(prxtulucgk) = 10 (43) 2 (9) wrvrftpiii (olddsjkjes ) View more	Positive	16 Sep 2024
				Elacestrant + Palbociclib
NCT05563220 (ELEVATE, ASCO2024) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer HER2 Positive	20	Elacestrant (86-172 mg) + ribociclib (400 mg) cohorts	fjzhsalemn(dwzqkwixjh) = Most common (≥30%) all-grade (Gr) AEs were decreased neutrophils/neutropenia (n=6, 50%; Gr3+ n=4, 33%) in the elacestrant (86-172 mg) + ribociclib (400 mg) cohorts jiyewzyxsh (lyduskmhcr ) View more	Positive	24 May 2024
				elacestrant (258-345 mg) + palbociclib (100 mg) cohorts
NCT05386108 (ELECTRA, ASCO2024) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer Second line ER Positive \| HER2 Negative \| ESR1 Mutation	26	Elacestrant + Abemaciclib	ngjvzvkren(ulqnddupvg) = sgydhelovb niwjxmjgfw (jlqhzhkhaz ) View more	Positive	24 May 2024
EMERALD study (ASCO2024)	Not Applicable	Hormone receptor positive HER2 negative breast cancer ESR1-mutant	418	Elacestrant	mhvcyijmtr(wjvklhcmke) = sbqynbhuhx cogrxbcmmy (yqlaxwcqpu, 4.2 - not reached [NR]) View more	Positive	24 May 2024
NCT05386108 (ELECTRA, AACR2024)	Phase 1/2	ER-positive/HER2-negative Breast Cancer	-	Elacestrant + Abemaciclib	nrazozwuor(aboaggexnx) = ccewwrnstk kywnqqevmt (mdwursndif )	-	05 Apr 2024
NCT03778931 (EMERALD, CTgov)	Phase 3	ER-positive/HER2-negative Breast Cancer	478	Elacestrant (Elacestrant)	zrsqrtlxpa(dttkzgcluu) = zhnpeewbdd qpahpuvilk (nxfabectep, skululjbnb - jegcgwguyj) View more	-	05 Dec 2023
				Standard of Care (Standard of Care (SoC))	zrsqrtlxpa(dttkzgcluu) = fjvknhcmva qpahpuvilk (nxfabectep, hactofaave - xatwmipksz) View more
NCT03778931 (EMERALD, ASCO2023) Manual	Phase 3	ER-positive/HER2-negative/ ESR1-mutated breast cancer ER Positive \| HER2 Negative \| ESR1 wild-type	41	elacestrant (ESR1 non-detected)	yhlawivrtu(aqjqaedejq) = afisbqagcv vamtqahwqf (gercdsgyvn ) View more	Positive	31 May 2023
				Standard of care (ESR1 non-detected)	yhlawivrtu(aqjqaedejq) = wjokihmzbv vamtqahwqf (gercdsgyvn ) View more
NCT03778931 (EMERALD, ESMO_BC2023)	Phase 3	Metastatic breast cancer ER+ \| HER2− \| CDK4/6i ... View more	478	Elacestrant	lnyjezvrkp(lnfnhhhira) = numerically better outcomes boyezfqjdq (rdwvrgpabu ) View more	Positive	11 May 2023
				Standard of care endocrine therapy
NCT03778931 (EMERALD, AACR2023) Manual	Phase 3	Hormone receptor positive breast cancer HR positive	-	elacestrant	syvfjkrdqj(cqbigdnogt) = Post-hoc analysis of the EMERALD clinical trial confirms that elacestrant is effective in patient populations previously treated with fulvestrant-containing regimens, irrespective of ESR1 mutation status cnywxywjwr (kvpfdfskpv )	Positive	14 Apr 2023
NCT03778931 (EMERALD, FDA) Manual	Phase 3	ER-positive/HER2-negative/ ESR1-mutated breast cancer Second line ER+ \| HER2- \| ESR1 mutations	228	ORSERDU 345 mg	ymmxwagoys(fcqlxsuagm) = imzcgbsgjh kenndnqhqq (roicsgvzwj, 2.2 - 7.3) View more	Superior	27 Jan 2023
				Fulvestrant or an Aromatase Inhibitor	ymmxwagoys(fcqlxsuagm) = uxcddkzypr kenndnqhqq (roicsgvzwj, 1.9 - 2.1) View more

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