ER+/ HER2 -ve Breast Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "ER positive, HER2 negative Breast Cancer Pipeline Insight" report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in ER positive, HER2 negative Breast Cancer pipeline landscape. It covers the ER+/ HER2 -ve Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the ER+/ HER2 -ve Breast Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Stay ahead with the latest insights! Download DelveInsight's comprehensive ER+/ HER2 -ve Breast Cancer Pipeline Report to explore emerging therapies, key ER+/ HER2 -ve Breast Cancer Companies, and future ER+/ HER2 -ve Breast Cancer treatment landscapes @ ER+/ HER2 -ve Breast Cancer Pipeline Outlook Report [https://www.delveinsight.com/sample-request/er-her2-ve-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Key Takeaways from the ER+/ HER2 -ve Breast Cancer Pipeline Report

* In February 2025:- SOLTI Breast Cancer Research Group:- This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67 greater than or equal to 20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole.
* In February 2025:- Stemline Therapeutics Inc.;- 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.
* In February 2025:- AstraZeneca:- This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
* In February 2025:- Hoffmann-La Roche:- This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. Cohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor (ER)-positive, HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting.
* In February 2025:- Sermonix Pharmaceuticals Inc.:- This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
* In February 2025:- Arvinas Estrogen Receptor Inc.:- This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib (IBRANCE Registered ) in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.
* DelveInsight's ER+/ HER2 -ve Breast Cancer pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline therapies for ER+/ HER2 -ve Breast Cancer treatment.
* The leading ER+/ HER2 -ve Breast Cancer Companies such as AstraZeneca, Atossa Therapeutics, Inc., Accutar Biotechnology Inc, VelosBio Inc, Merus N.V., Pfizer, Olema Pharmaceuticals, Inc., Eli Lilly and Company, Novartis Pharmaceuticals, Hoffmann-La Roche, Ellipses Pharma, BeiGene and others.
* Promising ER+/ HER2 -ve Breast Cancer Therapies such as Entinostat, Aromatase Inhibitor (AI) Therapy, cetuximab, cisplatin, Palbociclib 125Mg Tab and others.

Discover how the ER+/ HER2 -ve Breast Cancer treatment paradigm is evolving. Access DelveInsight's in-depth ER+/ HER2 -ve Breast Cancer Pipeline Analysis for a closer look at promising breakthroughs @ ER+/ HER2 -ve Breast Cancer Clinical Trials and Studies [https://www.delveinsight.com/sample-request/er-her2-ve-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

ER+/ HER2 -ve Breast Cancer Emerging Drugs Profile

* Camizestrant: AstraZeneca

Camizestrant, is a next-generation oral selective estrogen receptor degrader (SERD), as a promising treatment for ER-positive, HER2-negative breast cancer. This drug, developed by AstraZeneca, and has shown significant potential in improving progression-free survival (PFS) compared to the standard treatment with fulvestrant, which has been the mainstay therapy for almost two decades. Camizestrant has demonstrated significant efficacy in clinical trials, particularly the SERENA-2 phase II trial. In this study, camizestrant was compared to fulvestrant, a well-established treatment. Patients receiving camizestrant showed improved progression-free survival (PFS) at doses of 75 mg and 150 mg, with median PFS of 7.2 and 9.2 months, respectively, compared to 3.7 months for those on fulvestrant. This trial also highlighted camizestrant's ability to reduce ESR1-mutant circulating tumor DNA, indicating a strong efficacy in combatting endocrine-resistant tumors. Safety profiles from these studies indicate that camizestrant is generally well-tolerated, with manageable side effects such as fatigue, anemia, and mild visual disturbances. The favorable balance between efficacy and safety has supported the advancement of camizestrant into further phase III trials, like SERENA-4 and SERENA-6, which are exploring its use in combination with CDK4/6 inhibitors for broader clinical application. Currently, the drug is in Phase III stage of its development for the treatment of HER2-negative breast cancer.

* (Z)-endoxifen: Atossa Therapeutics, Inc.

(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies have demonstrated that the therapeutic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKC1, a known oncogenic protein. (Z)-endoxifen also appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with tamoxifen. Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions in the stomach convert a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa's (Z)-endoxifen has been shown to be well tolerated in Phase I studies and in a small Phase II study of women with breast cancer. Currently, the drug is in Phase II stage of its development for the treatment of ER-positive, HER2-negative breast cancer.

* AC699: Accutar Biotechnology Inc

AC699 is a potent and selective orally bioavailable, chimeric degrader of estrogen receptor (ER) , and offers a potential new breast cancer treatment option based on a differentiated mechanism of action as compared to fulvestrant and novel SERDs with deeper ER degradation as demonstrated in preclinical studies. AC699 is currently being evaluated in an ongoing Phase I clinical study as a single agent for the treatment of ER-positive / HER2-negative locally advanced or metastatic breast cancer. The primary objectives are to evaluate the safety and tolerability of AC699. Secondary and exploratory objectives include pharmacokinetics, preliminary efficacy and pharmacodynamic evaluation. The study uses a 3+3 dose-escalation design, with once-daily oral dosing of AC699 at 100, 200, 300, 400, and 600 mg.

The ER+/ HER2 -ve Breast Cancer pipeline report provides insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of ER+/ HER2 -ve Breast Cancer with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for ER+/ HER2 -ve Breast Cancer Treatment.
* ER+/ HER2 -ve Breast Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* ER+/ HER2 -ve Breast Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the ER+/ HER2 -ve Breast Cancer market.

Get a detailed analysis of the latest innovations in the ER+/ HER2 -ve Breast Cancer pipeline. Explore DelveInsight's expert-driven report today! @ ER+/ HER2 -ve Breast Cancer Unmet Needs [https://www.delveinsight.com/sample-request/er-her2-ve-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

ER+/ HER2 -ve Breast Cancer Companies

AstraZeneca, Atossa Therapeutics, Inc., Accutar Biotechnology Inc, VelosBio Inc, Merus N.V., Pfizer, Olema Pharmaceuticals, Inc., Eli Lilly and Company, Novartis Pharmaceuticals, Hoffmann-La Roche, Ellipses Pharma, BeiGene and others.

ER+/ HER2-VE Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Oral
* Intravenous
* Subcutaneous
* Parenteral
* Topical

ER+/ HER2 -ve Breast Cancer Products have been categorized under various Molecule types such as

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

Download DelveInsight's latest report to gain strategic insights into upcoming ER+/ HER2 -ve Breast Cancer Therapies and key ER+/ HER2 -ve Breast Cancer Developments @ ER+/ HER2 -ve Breast Cancer Market Drivers and Barriers, and Future Perspectives [https://www.delveinsight.com/sample-request/er-her2-ve-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Scope of the ER+/ HER2 -ve Breast Cancer Pipeline Report

* Coverage- Global
* ER+/ HER2 -ve Breast Cancer Companies- AstraZeneca, Atossa Therapeutics, Inc., Accutar Biotechnology Inc, VelosBio Inc, Merus N.V., Pfizer, Olema Pharmaceuticals, Inc., Eli Lilly and Company, Novartis Pharmaceuticals, Hoffmann-La Roche, Ellipses Pharma, BeiGene and others.
* ER+/ HER2 -ve Breast Cancer Therapies- Entinostat, Aromatase Inhibitor (AI) Therapy, cetuximab, cisplatin, Palbociclib 125Mg Tab and others.
* ER+/ HER2 -ve Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* ER+/ HER2 -ve Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Which companies are leading the race in ER+/ HER2 -ve Breast Cancer drug development? Find out in DelveInsight's exclusive ER+/ HER2 -ve Breast Cancer Pipeline Report-access it now! @ ER+/ HER2 -ve Breast Cancer Emerging Drugs and Major Companies [https://www.delveinsight.com/sample-request/er-her2-ve-breast-cancer-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Content

* Introduction
* Executive Summary
* ER+/ HER2-VE Breast Cancer: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* ER positive, HER2 negative Breast Cancer- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Camizestrant: AstraZeneca
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* (Z)-endoxifen: Atossa Therapeutics, Inc.
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* AC699: Accutar Biotechnology Inc
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Inactive Products
* ER+/ HER2-VE Breast Cancer Key Companies
* ER+/ HER2-VE Breast Cancer Key Products
* ER+/ HER2-VE Breast Cancer- Unmet Needs
* ER+/ HER2-VE Breast Cancer- Market Drivers and Barriers
* ER+/ HER2-VE Breast Cancer- Future Perspectives and Conclusion
* ER+/ HER2-VE Breast Cancer Analyst Views
* ER+/ HER2-VE Breast Cancer Key Companies
* Appendix

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