HER2-Negative Breast Cancer Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Clinical Trials, Therapies, Medication, NDA Approval, IND, Mechanism of Action, Route of Administration by DelveInsight

(Albany, USA) DelveInsight's HER2 negative Breast Cancer Pipeline Insight 2025 report offers exhaustive global coverage of available, marketed, and pipeline therapies in different phases of clinical development, major pharmaceutical companies working to advance the pipeline space, and future growth potential of the HER2 negative Breast Cancer pipeline domain.
As per DelveInsight's assessment, HER2 negative Breast Cancer Pipeline analysis depicts a robust space with 85+ active players working to develop 85+ pipeline treatment therapies.

Click here to know more about the HER2 negative Breast Cancer Pipeline report offerings: HER2 negative Breast Cancer Pipeline Analysis - https://www.delveinsight.com/report-store/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Some of the essential takeaways from the HER2 negative Breast Cancer Pipeline report:
• DelveInsight's HER2 negative Breast Cancer Pipeline analysis depicts a robust space with 85+ active players working to develop 85+ pipeline treatment therapies.
• Some of the key pharmaceutical companies working to develop potential drug candidates to improve the HER2 negative Breast Cancer treatment scenario include BeiGene, Olema Pharmaceuticals, AstraZeneca, Radius Health, Adagene Inc, H3 Biomedicine Inc., Daiichi Sankyo, Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., OncoSec Medical Incorporated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Pfizer, InventisBio Co., Ltd, Hoffmann-La Roche, Angiochem, Bristol-Myers Squibb, Eisai Co., Ltd., Context Therapeutics, Boehringer Ingelheim, CytomX Therapeutics, Beta Pharma (Suzhou) Co., Ltd., Eli Lilly and Company, Laekna Limited, Sermonix Pharmaceuticals Inc., Modra Pharmaceuticals, MedImmune LLC, QED Therapeutics, Inc., Tyme, Inc., PIQUR Therapeutics, Pfizer, Merus N.V., Seagen, Relay Therapeutics, Inc., Blueprint Medicines Corporation, TransThera Sciences (Nanjing), Inc., HUTCHMED, VelosBio Inc., Dantari, Inc., GlaxoSmithKline, G1 Therapeutics, Inc., Spectrum Pharmaceuticals, Inc, Taizhou EOC Pharma Co., Ltd., Xuanzhu Biopharmaceutical Co., Ltd., Regor Pharmaceuticals Inc, Astex Pharmaceuticals, Inc., Kind Pharmaceuticals LLC, Genor Biopharma Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Ltd., Nerviano Medical Sciences, Tolmar Inc., Zeno Alpha Inc., Accutar Biotechnology Inc, Jiangsu Hansoh Pharmaceutical Co., Ltd., Zenith Epigenetics, Cantargia, BioLite, Inc., PharmAbcine, Ayala Pharmaceuticals, Inc., ERYtech Pharma, SynCore Biotechnology Co., Ltd., Phoenix Molecular Designs, Chipscreen Biosciences, Ltd., OncoTherapy Science, Inc., OncoPep, Inc., and many others.
• Essential HER2 negative Breast Cancer pipeline therapies such as BGB-290, OP-1250, AZD9833, Elacestrant, ADG106, H3B-6545, Dato-DXd, HRS8807, TAVO, Mitoxantrone Hydrochloride, Gedatolisib, D-0502, Ipatasertib, ANG1005, Nivolumab, Ipilimumab, Lenvatinib, Onapristone, Xentuzumab, CX-2009, BPI-1178, LY3484356, Afuresertib, Lasofoxifene, ModraDoc006/r, MEDI4736, Infigratinib, SM-88, PQR309, PF-07248144, MCLA-128, SGN-CD228A, RLY-2608, BLU-222, TT-00420, HMPL-013, Zilovertamab vedotin, DAN-222, Niraparib, G1T38, Poziotinib Hydrochloride, EOC202, XZP-3287, RGT-419B, ASTX727, AND019, Lerociclib, SGN-STNV, SCR-6852, NMS-03305293, TOL2506, ZN-c5, AC682, HS-10342, ZEN003694, Nadunolimab, BLEX 404, Olinvacimab, AL101, eryaspase, EndoTAG-1, PMD-026, Chiauranib, OTS167PO, PVX-410, and others are under development in different phases of clinical trials.
• 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.
• In December 2024, Olema Pharmaceuticals presented clinical results from the ongoing Phase Ib/II study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer at SABCS 2024.
• In October 2024, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved ItovebiTM (inavolisib) for use in combination with palbociclib (Ibrance®) and fulvestrant. This approval is for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer, as identified by an FDA-approved test, after recurrence following adjuvant endocrine therapy. The PIK3CA mutation is present in approximately 40% of HR-positive metastatic breast cancers.
• In January 2022, Celcuity announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation to the Company's lead drug candidate, gedatolisib, for the treatment of patients with HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy.
• In December 2021, H3 Biomedicine Inc. (H3), announced the presentation of two posters at the 2021 San Antonio Breast Cancer Symposium (SABCS) being held in a hybrid format on December 7- 10, 2021. The presentations include interim investigational data from H3's ongoing clinical development program, H3B-6545, a potential first-in-class, orally available Selective ERα Covalent Antagonist (SERCA), in women with ER-positive, HER2-negative breast cancer.
• The investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly decreased the risk of death or disease progression and increased progression-free survival compared with standard-of-care endocrine therapy for postmenopausal patients with estrogen receptor (ER)-positive/HER2-negative metastatic breast cancers that progressed on prior endocrine and targeted therapies, according to results from the phase III EMERALD trial, which were presented at the San Antonio Breast Cancer Symposium, held December 7-10, 2021.
• In November 2021, Olema Pharmaceuticals, Inc. announced the first clinical data from the Phase 1 dose-escalation portion of the ongoing Phase 1/2 clinical trial of OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) in development for the treatment of metastatic breast cancer and other women's cancers.

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The HER2 negative Breast Cancer pipeline report lays down detailed profiles of the pipeline assets, comparative analysis of clinical and non-clinical stage HER2 negative Breast Cancer products, inactive and dormant assets, comprehensive assessment of driving and restraining factors, as well as the opportunities and risks in the HER2 negative Breast Cancer pipeline landscape.

HER2 negative Breast Cancer Overview
HER2 negative breast cancer refers to a type of breast cancer that does not overexpress the human epidermal growth factor receptor 2 (HER2) protein. HER2 negative breast cancer is categorized into hormone receptor-positive (HR+) or triple-negative breast cancer (TNBC) subtypes. HER2 negative breast cancer is more common than HER2 positive types and often requires different treatment strategies. HER2 negative breast cancer tends to respond well to hormonal therapies like tamoxifen or aromatase inhibitors, especially in HR+ cases. HER2 negative breast cancer, particularly the triple-negative form, is more aggressive and has limited treatment options. HER2 negative breast cancer diagnosis typically involves biopsy, immunohistochemistry (IHC), and fluorescence in situ hybridization (FISH) tests.
HER2 negative breast cancer treatment may include surgery, radiation, chemotherapy, and targeted hormone therapies. HER2 negative breast cancer patients often benefit from personalized treatment plans based on receptor status and genetic profiling. HER2 negative breast cancer prognosis varies, with hormone receptor-positive types having better outcomes than triple-negative cases. HER2 negative breast cancer research is actively exploring new targeted therapies and immunotherapies. HER2 negative breast cancer awareness is essential for early detection and effective management. HER2 negative breast cancer support groups and clinical trials play a vital role in improving patient care and outcomes.

Find out more about the disease and recent developments in HER2 negative Breast Cancer Pipeline landscape @ HER2 negative Breast Cancer Drugs in pipeline - https://www.delveinsight.com/report-store/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

HER2 negative Breast Cancer Therapeutics Assessment
The HER2 negative Breast Cancer Pipeline report proffers an integral view of the HER2 negative Breast Cancer emerging novel therapies segmented by Stage, Product Type, Molecule Type, Mechanism of Action, and Route of Administration.

HER2 negative Breast Cancer Drugs Phases
DelveInsight's report covers around 75+ products under different phases of clinical development like
• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

HER2 negative Breast Cancer Route of Administration
HER2-Negative 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
• Parenteral
• Intravitreal
• Subretinal
• Topical

HER2 negative Breast Cancer Molecule Type
Products have been categorized under various Molecule types such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

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Scope of the HER2 negative Breast Cancer Pipeline Report
• Coverage: Global
• Therapeutic Assessment By HER2 negative Breast Cancer Product Type: Mono, Combination, Mono/Combination
• Therapeutic Assessment By HER2 negative Breast Cancer Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III, Pre-registration, Inactive candidates
• Therapeutics Assessment By HER2 negative Breast Cancer Therapeutics Route of Administration: Oral, Intravenous, Inhalation, Subcutaneous
• Therapeutics Assessment By HER2 negative Breast Cancer Therapies Molecule Type: Gene therapy, Stem cell therapy, Small molecules
• Therapeutics Assessment By HER2 negative Breast Cancer Therapies Mechanism of Action: Selective estrogen receptor degrader, Estrogen receptor alpha antagonist, Phosphoinositide 3-kinase (PI3K) inhibitor, Selective estrogen receptor degraders
• Key HER2 negative Breast Cancer Companies: BeiGene (NASDAQ: BGNE), Olema Pharmaceuticals (NASDAQ: OLMA), AstraZeneca (NASDAQ: AZN), Radius Health (NASDAQ: RDUS), Adagene Inc. (NASDAQ: ADAG), Daiichi Sankyo, Inc. (TSE: 4568), Shanghai Hengrui Pharmaceutical Co., Ltd. (SSE: 600276), OncoSec Medical Incorporated (NASDAQ: ONCS), Pfizer (NYSE: PFE), Hoffmann-La Roche (SWX: ROG), Bristol-Myers Squibb (NYSE: BMY), Eisai Co., Ltd. (TSE: 4523), Boehringer Ingelheim (Private), CytomX Therapeutics (NASDAQ: CTMX), Eli Lilly and Company (NYSE: LLY), Merus N.V. (NASDAQ: MRUS), Seagen (NASDAQ: SGEN), Relay Therapeutics, Inc. (NASDAQ: RLAY), Blueprint Medicines Corporation (NASDAQ: BPMC), HUTCHMED (NASDAQ: HCM), GlaxoSmithKline (NYSE: GSK), G1 Therapeutics, Inc. (NASDAQ: GTHX), Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI), Astex Pharmaceuticals, Inc. (Private), Jiangsu Simcere Pharmaceutical Co., Ltd. (HKEX: 2096), Jiangsu Hansoh Pharmaceutical Co., Ltd. (HKEX: 3692), Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), ERYtech Pharma (NASDAQ: ERYP), SynCore Biotechnology Co., Ltd. (TWO: 4192), BeiGene (HKEX: 6160), Simcere Pharmaceutical Group Ltd. (HKEX: 2096), Genor Biopharma Co., Ltd. (HKEX: 6998), BioLite, Inc. (OTC: BLTE), PharmAbcine (KOSDAQ: 208340), Chipscreen Biosciences, Ltd. (SHE: 688321), OncoTherapy Science, Inc. (TSE: 4564).
• Key HER2 negative Breast Cancer Pipeline Therapies: BGB-290, OP-1250, AZD9833, Elacestrant, ADG106, H3B-6545, Dato-DXd, HRS8807, TAVO, Mitoxantrone Hydrochloride, Gedatolisib, D-0502, Ipatasertib, ANG1005, Nivolumab, Ipilimumab, Lenvatinib, Onapristone, Xentuzumab, CX-2009, BPI-1178, LY3484356, Afuresertib, Lasofoxifene, ModraDoc006/r, MEDI4736, Infigratinib, SM-88, PQR309, PF-07248144, MCLA-128, SGN-CD228A, RLY-2608, BLU-222, TT-00420, HMPL-013, Zilovertamab vedotin, DAN-222, Niraparib, G1T38, Poziotinib Hydrochloride, EOC202, XZP-3287, RGT-419B, ASTX727, AND019, Lerociclib, SGN-STNV, SCR-6852, NMS-03305293, TOL2506, ZN-c5, AC682, HS-10342, ZEN003694, Nadunolimab, BLEX 404, Olinvacimab, AL101, eryaspase, EndoTAG-1, PMD-026, Chiauranib, OTS167PO, PVX-410, and others.

Dive deep into rich insights for emerging HER2 negative Breast Cancer Pipeline therapies and assessment, visit @ https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight - https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Introduction
2. Executive Summary
3. HER2 negative Breast Cancer: Overview
4. HER2 negative Breast Cancer Pipeline Therapeutics
5. Late Stage HER2 negative Breast Cancer Products (Phase III)
6. Dato-DXd: Daiichi Sankyo, Inc.
7. Mid Stage HER2 negative Breast Cancer Products (Phase II)
8. CX-2009: CytomX Therapeutics
9. Early Stage Products (Phase I/II)
10. BPI-1178: Beta Pharma (Suzhou) Co., Ltd.
11. HER2 negative Breast Cancer Therapeutic Assessment
12. Inactive HER2 negative Breast Cancer Products
13. Collaborations Assessment- Licensing / Partnering / Funding
14. HER2 negative Breast Cancer Unmet Needs
15. HER2 negative Breast Cancer Market Drivers
16. HER2 negative Breast Cancer Market Barriers
17. Appendix
18. About DelveInsight

For further information on the HER2 negative Breast Cancer clinical trials and current pipeline therapeutics, reach out @ https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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