ER+/ HER2-VE Breast Cancer Pipeline Outlook Report 2025: Key 20+ Companies and Breakthrough Therapies Shaping the Future Landscape
Stay ahead with the latest insights! Download DelveInsight's comprehensive ER+/ HER2 -ve Breast Cancer Pipeline Report to explore emerging therapies, key Companies, and future treatment landscapes @ ER+/ HER2 -ve Breast Cancer Pipeline Outlook Report
In August 2025, Yale University announced a phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Patients with ER+ breast cancer anatomic stage IIB or III at diagnosis who are at least five years from diagnosis and have completed intended course of adjuvant endocrine therapy and are currently off endocrine therapy will be screened with ctDNA testing.
In July 2025, Atossa Therapeutics Inc. announced a study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.
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 pipeline Analysis for a closer look at promising breakthroughs @ ER+/ HER2 -ve Breast Cancer Clinical Trials and Studies
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 PKCβ1, 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 is a potent and selective orally bioavailable, chimeric degrader of estrogen receptor (ER) α, 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 ERα 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
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 developments @ ER+/ HER2 -ve Breast Cancer Market Drivers and Barriers, and Future Perspectives
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 pipeline Report—access it now! @ ER+/ HER2 -ve Breast Cancer Emerging Drugs and Major Companies
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
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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Website: https://www.delveinsight.com/report-store/er-her2-ve-breast-cancer-pipeline-insight
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