HER2 Negative Metastatic Breast Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight

HER2 Negative Metastatic Breast Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight

DelveInsight’s, “HER2 Negative Metastatic Breast Cancer Pipeline Insight” report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Her2 Negative Metastatic Breast Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the 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 HER2 Negative Metastatic Breast Cancer Pipeline Report to explore emerging therapies, key HER2 Negative Metastatic Breast Cancer Companies, and future HER2 Negative Metastatic Breast Cancer treatment landscapes @ HER2 Negative Metastatic Breast Cancer Pipeline Outlook Report

 

Key Takeaways from the HER2 Negative Metastatic Breast Cancer Pipeline Report

  • In February 2025:- Washington University School of Medicine:- This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC).
  • In February 2025:- Stemline Therapeutics Inc.:- The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in the metastatic setting.
  • In February 2025:- Merck Sharp & Dohme LLC:- The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator’s choice of fulvestrant or exemestane) in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) unresectable metastatic breast cancer. There is no formal hypothesis testing in this study.
  • In February 2025:- Puma Biotechnology Inc.:- PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.
  • In February 2025:- GE Healthcare:- This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC). Each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria.
  • DelveInsight’s HER2 Negative Metastatic Breast Cancer pipeline report depicts a robust space with 50+ active players working to develop 50+ pipeline therapies for HER2 Negative Metastatic Breast Cancer treatment.
  • The leading HER2 Negative Metastatic Breast Cancer Companies such as BeiGene, Context Therapeutics, Astex Pharmaceuticals, Eisai Inc., AstraZeneca, Dantari, Inc., and others.
  • Promising HER2 Negative Metastatic Breast Cancer Therapies such as ADI-PEG 20, DAN-222, Niraparib, Cetuximab, BGB-290, and others.

 

Discover how the HER2 Negative Metastatic Breast Cancer treatment paradigm is evolving. Access DelveInsight’s in-depth HER2 Negative Metastatic Breast Cancer Pipeline Analysis for a closer look at promising breakthroughs @ HER2 Negative Metastatic Breast Cancer Clinical Trials and Studies

 

HER2 Negative Metastatic Breast Cancer Emerging Drugs Profile

 

  • Pamiparib: BeiGene

Pamiparib is a selective small molecule inhibitor of poly ADP-ribose polymerase 1 (PARP1) and PARP2 enzymes that is being evaluated as a potential monotherapy and in combinations for the treatment of various solid tumors. It is believed that pamiparib has the potential to be differentiated from other PARP inhibitors because of its brain penetration, greater selectivity, strong DNA-trapping activity, and good oral bioavailability demonstrated in preclinical models. . Currently, the drug is being developed in the Phase II stage of clinical trial evaluation for the treatment of Her2 Negative Metastatic Breast Cancers.

 

  • Onapristone: Context Therapeutics

ONA-XR is an investigational medicine that prevents progesterone signaling by blocking the interaction between progesterone and its binding partner, progesterone receptor. Onapristone is the only known full PR antagonist. Currently, there are no approved therapies that selectively target progesterone receptor positive (PR+) cancers. Preclinical and clinical data suggest that onapristone extended release (ONA-XR) has anticancer activity by inhibiting PR binding to chromatin, down regulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently being evaluated in four Phase 2 trials and two Phase 0 biomarker pharmacodynamic trials in women with primary or metastatic breast, ovarian, and endometrial cancers. . Currently, the drug is being developed in the Phase II stage of clinical trial evaluation for the treatment of Her2 Negative Metastatic Breast Cancers.

 

The HER2 Negative Metastatic Breast Cancer pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of HER2 Negative Metastatic 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 HER2 Negative Metastatic Breast Cancer Treatment.
  • HER2 Negative Metastatic Breast Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • HER2 Negative Metastatic 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 HER2 Negative Metastatic Breast Cancer market.

 

Get a detailed analysis of the latest innovations in the HER2 Negative Metastatic Breast Cancer pipeline. Explore DelveInsight’s expert-driven report today! @ HER2 Negative Metastatic Breast Cancer Unmet Needs

 

HER2 Negative Metastatic Breast Cancer Companies

BeiGene, Context Therapeutics, Astex Pharmaceuticals, Eisai Inc., AstraZeneca, Dantari, Inc., and others.

 

Her2 Negative Metastatic Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

  • Intra-articular
  • Intraocular
  • Intrathecal
  • Intravenous
  • Ophthalmic
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical
  • Transdermal

 

HER2 Negative Metastatic Breast Cancer Products have been categorized under various Molecule types such as

  • Oligonucleotide
  • Peptide
  • Small molecule

 

Download DelveInsight’s latest report to gain strategic insights into upcoming HER2 Negative Metastatic Breast Cancer Therapies and key HER2 Negative Metastatic Breast Cancer Developments @ HER2 Negative Metastatic Breast Cancer Market Drivers and Barriers, and Future Perspectives

 

Scope of the HER2 Negative Metastatic Breast Cancer Pipeline Report

  • Coverage- Global
  • HER2 Negative Metastatic Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • HER2 Negative Metastatic Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
  • HER2 Negative Metastatic Breast Cancer Companies- BeiGene, Context Therapeutics, Astex Pharmaceuticals, Eisai Inc., AstraZeneca, Dantari, Inc., and others.
  • HER2 Negative Metastatic Breast Cancer Therapies- ADI-PEG 20, DAN-222, Niraparib, Cetuximab, BGB-290, and others.

 

Which companies are leading the race in HER2 Negative Metastatic Breast Cancer drug development? Find out in DelveInsight’s exclusive HER2 Negative Metastatic Breast Cancer Pipeline Report—access it now! @ HER2 Negative Metastatic Breast Cancer Emerging Drugs and Major Companies

 

Table of Content

  1. Introduction
  2. Executive Summary
  3. Her2 Negative Metastatic Breast Cancer: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Her2 Negative Metastatic Breast Cancer– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Drug name : Company name
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. Pamiparib: BeiGene
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. Drug name : Company name
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. Drug name : Company name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Her2 Negative Metastatic Breast Cancer Key Companies
  21. Her2 Negative Metastatic Breast Cancer Key Products
  22. Her2 Negative Metastatic Breast Cancer- Unmet Needs
  23. Her2 Negative Metastatic Breast Cancer- Market Drivers and Barriers
  24. Her2 Negative Metastatic Breast Cancer- Future Perspectives and Conclusion
  25. Her2 Negative Metastatic Breast Cancer Analyst Views
  26. Her2 Negative Metastatic Breast Cancer Key Companies
  27. Appendix

 

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