“HER2 Negative Breast Cancer Pipeline Insight, 2025“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the HER2 Negative Breast Cancer Market.
The HER2 Negative Breast Cancer Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.
Some of the key takeaways from the HER2 Negative Breast Cancer Pipeline Report:
Companies across the globe are diligently working toward developing novel HER2 Negative Breast Cancer treatment therapies with a considerable amount of success over the years.
HER2 Negative Breast Cancer companies working in the treatment market are EnhancedBio Inc., Relay Therapeutics, Inc., Prelude Therapeutics, Ellipses Pharma, Beta Pharma, CytomX Therapeutics, Atossa Therapeutics, Inc, AstraZeneca, Roche, Celcuity, Inc., BeiGene, Olema Pharmaceuticals, Inc., Adagene Inc, Daiichi Sankyo, Inc., Shanghai Hengrui Pharmaceutical Co., Genentech, and others, are developing therapies for the HER2 Negative Breast Cancer treatment
Emerging HER2 Negative Breast Cancer therapies in the different phases of clinical trials are- ER-PROTAC, RLY-2608, PRT2527, EP0062, BPI-1178, CX-2009, Z-endoxifen, AZD9833, GDC-9545, Gedatolisib, BGB-290, OP-1250, AZD9833, ADG106, Dato-DXd, HRS8807, Ipatasertib, and others are expected to have a significant impact on the HER2 Negative Breast Cancer market in the coming years.
In January 2025, Genentech Therapeutics’ Phase III trial evaluating Itovebi (inavolisib) in patients with specific forms of metastatic breast cancer has achieved the key oncology benchmark of improved overall survival (OS), while also significantly delaying disease progression. The randomized, double-blind study (NCT04191499) further demonstrated that the combination of Itovebi with Ibrance (palbociclib) and Faslodex (fulvestrant) met a secondary endpoint by delivering a statistically significant and clinically meaningful OS benefit in patients with PIK3CA-mutated, hormone receptor-positive (HR+), and HER2-negative breast cancer.
In February 2025, Washington University School of Medicine is conducting a Phase Ib/II clinical trial to assess the safety and effectiveness of zunsemetinib (ATI-450) in combination with capecitabine for patients diagnosed with hormone receptor-positive, HER2-negative (HR+/HER2-) metastatic breast cancer (MBC).
In February 2025, Stemline Therapeutics Inc. is conducting a study to assess the efficacy and safety of elacestrant over a 6-month period in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer who have not previously been treated with CDK4/6 inhibitors in the metastatic setting.
In February 2025, Merck Sharp & Dohme LLC is conducting a study to evaluate the safety and effectiveness of belzutifan (MK-6482) in combination with fulvestrant, compared to everolimus paired with an endocrine therapy (either fulvestrant or exemestane, as selected by the investigator), in adult patients with estrogen receptor-positive, HER2-negative (ER+/HER2-) unresectable metastatic breast cancer. This trial is exploratory and does not involve formal hypothesis testing.
In February 2025, Puma Biotechnology Inc. is conducting PUMA-ALI-1201, a randomized, multicenter Phase 2 trial aimed at optimizing the dose of alisertib in combination with endocrine therapy for patients with confirmed HR-positive/HER2-negative metastatic breast cancer (MBC). Participants must have experienced disease progression after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. The study will determine the most effective alisertib dose in combination with a selected endocrine therapy and will also assess the combination’s efficacy, safety, and pharmacokinetics. Additionally, the trial seeks to identify biomarker-defined subgroups that may derive the greatest benefit from this therapeutic approach.
In February 2025, GE Healthcare is conducting a multicenter study across France to assess how ESTROTEP PET/CT imaging influences treatment decisions in patients with metastatic breast cancer (MBC). Each participant will undergo a screening process to ensure they fulfill all inclusion requirements and do not meet any exclusion conditions.
In December 2024, Olema Pharmaceuticals shared clinical data from its ongoing Phase Ib/II trial evaluating palazestrant in combination with ribociclib for patients with ER-positive/HER2-negative advanced or metastatic breast cancer at SABCS 2024.
HER2 Negative Breast Cancer Overview
HER2-negative breast cancer is a type of breast cancer that tests negative for the human epidermal growth factor receptor 2 (HER2) protein. HER2 is a protein that promotes the growth of cancer cells, and when breast cancer is HER2-negative, it means the cancer cells do not overexpress this protein. This subtype includes hormone receptor-positive and triple-negative breast cancers. Treatment for HER2-negative breast cancer typically excludes HER2-targeted therapies and may involve hormone therapy, chemotherapy, or immunotherapy depending on the specific subtype and stage of the disease.
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Emerging HER2 Negative Breast Cancer Drugs Under Different Phases of Clinical Development Include:
ER-PROTAC: EnhancedBio Inc.
RLY-2608: Relay Therapeutics, Inc.
PRT2527: Prelude Therapeutics
EP0062: Ellipses Pharma
BPI-1178: Beta Pharma
CX-2009: CytomX Therapeutics
Z-endoxifen: Atossa Therapeutics, Inc
AZD9833: AstraZeneca
GDC-9545: Roche
Gedatolisib: Celcuity, Inc.
BGB-290: BeiGene
OP-1250: Olema Pharmaceuticals, Inc.
ADG106: Adagene Inc
Dato-DXd: Daiichi Sankyo, Inc.
HRS8807: Shanghai Hengrui Pharmaceutical Co.
Ipatasertib: Genentech
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
Intravenous
Subcutaneous
Topical
HER2 Negative Breast Cancer Molecule Type
HER2 Negative Breast Cancer Products have been categorized under various Molecule types, such as
Monoclonal Antibody
Peptides
Polymer
Small molecule
Gene therapy
HER2 Negative Breast Cancer Pipeline Therapeutics Assessment
HER2 Negative Breast Cancer Assessment by Product Type
HER2 Negative Breast Cancer By Stage and Product Type
HER2 Negative Breast Cancer Assessment by Route of Administration
HER2 Negative Breast Cancer By Stage and Route of Administration
HER2 Negative Breast Cancer Assessment by Molecule Type
HER2 Negative Breast Cancer by Stage and Molecule Type
DelveInsight’s HER2 Negative Breast Cancer Report covers around 85+ products under different phases of clinical development like
Late-stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I)
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
Route of Administration
Further HER2 Negative Breast Cancer product details are provided in the report. Download the HER2 Negative Breast Cancer pipeline report to learn more about the emerging HER2 Negative Breast Cancer therapies
Some of the key companies in the HER2 Negative Breast Cancer Therapeutics Market include:
Key companies developing therapies for HER2 Negative Breast Cancer are – Context Therapeutics, Boehringer Ingelheim, CytomX Therapeutics, Beta Pharma (Suzhou) Co., Ltd., Eli Lilly and Company, Laekna Limited, Sermonix Pharmaceuticals Inc., Modra Pharmaceuticals, 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., MedImmune LLC, QED Therapeutics, Inc., Tyme, Inc., PIQUR Therapeutics, Pfizer, andn others.
HER2 Negative Breast Cancer Pipeline Analysis:
The HER2 Negative Breast Cancer pipeline report provides insights into
The report provides detailed insights about companies that are developing therapies for the treatment of HER2 Negative 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 Breast Cancer Treatment.
HER2 Negative Breast Cancer key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
HER2 Negative 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 Breast Cancer market.
The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.
Download Sample PDF Report to know more about HER2 Negative Breast Cancer drugs and therapies
HER2 Negative Breast Cancer Pipeline Market Drivers
HER2 protein is considered a relevant biomarker for treatment, growing prevalence of Breast Cancer are some of the important factors that are fueling the HER2 Negative Breast Cancer Market.
HER2 Negative Breast Cancer Pipeline Market Barriers
However, poor understanding in the context of breast cancer subtype, lack of research in identification of factors involved in resistance and other factors are creating obstacles in the HER2 Negative Breast Cancer Market growth.
Scope of HER2 Negative Breast Cancer Pipeline Drug Insight
Coverage: Global
Key HER2 Negative Breast Cancer Companies: EnhancedBio Inc., Relay Therapeutics, Inc., Prelude Therapeutics, Ellipses Pharma, Beta Pharma, CytomX Therapeutics, Atossa Therapeutics, Inc, AstraZeneca, Roche, Celcuity, Inc., BeiGene, Olema Pharmaceuticals, Inc., Adagene Inc, Daiichi Sankyo, Inc., Shanghai Hengrui Pharmaceutical Co., Genentech, and others
Key HER2 Negative Breast Cancer Therapies: ER-PROTAC, RLY-2608, PRT2527, EP0062, BPI-1178, CX-2009, Z-endoxifen, AZD9833, GDC-9545, Gedatolisib, BGB-290, OP-1250, AZD9833, ADG106, Dato-DXd, HRS8807, Ipatasertib, and others
HER2 Negative Breast Cancer Therapeutic Assessment: HER2 Negative Breast Cancer current marketed and HER2 Negative Breast Cancer emerging therapies
HER2 Negative Breast Cancer Market Dynamics: HER2 Negative Breast Cancer market drivers and HER2 Negative Breast Cancer market barriers
Request for Sample PDF Report for HER2 Negative Breast Cancer Pipeline Assessment and clinical trials
Table of Contents
1. HER2 Negative Breast Cancer Report Introduction
2. HER2 Negative Breast Cancer Executive Summary
3. HER2 Negative Breast Cancer Overview
4. HER2 Negative Breast Cancer- Analytical Perspective In-depth Commercial Assessment
5. HER2 Negative Breast Cancer Pipeline Therapeutics
6. HER2 Negative Breast Cancer Late Stage Products (Phase II/III)
7. HER2 Negative Breast Cancer Mid Stage Products (Phase II)
8. HER2 Negative Breast Cancer Early Stage Products (Phase I)
9. HER2 Negative Breast Cancer Preclinical Stage Products
10. HER2 Negative Breast Cancer Therapeutics Assessment
11. HER2 Negative Breast Cancer Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. HER2 Negative Breast Cancer Key Companies
14. HER2 Negative Breast Cancer Key Products
15. HER2 Negative Breast Cancer Unmet Needs
16 . HER2 Negative Breast Cancer Market Drivers and Barriers
17. HER2 Negative Breast Cancer Future Perspectives and Conclusion
18. HER2 Negative Breast Cancer Analyst Views
19. Appendix
20. About DelveInsight
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
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