HER2-Negative Breast Cancer Pipeline and Clinical Trial Analysis: 70+ Players, 75+ Assets, and Key Clinical Breakthroughs, analyses DelveInsight

DelveInsight's "HER2-Negative Breast Cancer Pipeline Insight" report delivers an extensive analysis of more than 70 companies and 75 pipeline candidates shaping the HER2-negative breast cancer research landscape. The report features detailed profiles of investigational therapies across both clinical and preclinical stages of development. It also evaluates HER2-negative breast cancer treatments based on therapy type, development phase, route of administration, and molecular classification. In addition, the report identifies and reviews inactive or discontinued pipeline assets within this therapeutic area.

Stay informed with the latest developments! Access DelveInsight's comprehensive HER2-Negative Breast Cancer Pipeline Report to examine emerging drugs, leading companies, and future treatment directions @ HER2-Negative Breast Cancer Pipeline Outlook Report - https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Key Highlights from the HER2-Negative Breast Cancer Pipeline Report
• December 09, 2025 - Washington University School of Medicine conducted a Phase II clinical study evaluating the potential of PD 0332991 in early-stage ER-positive, HER2-negative breast cancer. The study aims to determine whether combining PD 0332991 with anastrozole can enhance pathological complete response rates versus historical aromatase inhibitor controls, while also reducing the proportion of patients exhibiting on-treatment Ki67 levels above 10%.
• December 04, 2025 - MedSIR announced a Phase II trial focused on improving the tolerability of sacituzumab govitecan in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) or luminal breast cancer. The study targets patients refractory to one or two prior standard chemotherapy regimens and not eligible for curative surgical intervention.
• December 04, 2025 - Merck Sharp & Dohme LLC initiated a Phase III, randomized, open-label study assessing the efficacy and safety of Sac-TMT (sacituzumab tirumotecan, MK-2870) followed by carboplatin/paclitaxel versus chemotherapy. Both treatment arms are administered in combination with pembrolizumab as neoadjuvant therapy in patients with high-risk, early-stage TNBC or hormone receptor-low positive/HER2-negative breast cancer.
• DelveInsight's HER2-Negative Breast Cancer pipeline analysis showcases a highly competitive and dynamic environment, with over 70 active organizations advancing more than 75 therapeutic candidates for disease management.
• Leading Companies in the HER2-Negative Breast Cancer Space include Genentech, CytomX Therapeutics, H3 Biomedicine, Regor Therapeutics, Immutep Limited, Merck & Co, Klus Pharma, Olema Pharmaceuticals, BeiGene, AstraZeneca, Janssen/Merck/GSK, Ono Pharmaceutical, Laekna Therapeutics, NanoMab, InSilico Medicine, TYK Medicine, Shanghai Pharmaceutical Group, Verastem Oncology, Allarity Therapeutics, Shenzhen Yangli Pharmaceutical Technology, Phoenix Molecular Designs, and several others.
• Prominent treatment options in the pipeline include Doxorubicin, Cyclophosphamide, Utidelone in combination with Bevacizumab, Capecitabine, Carboplatin, Cisplatin, among others.

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The HER2-Negative Breast Cancer Pipeline Report presents a comprehensive disease overview, current pipeline landscape, and a detailed therapeutic evaluation of key investigational drugs.
It also emphasizes existing unmet needs within the HER2-negative breast cancer patient population.

HER2-Negative Breast Cancer Overview
Breast cancer is the most frequently diagnosed cancer among women worldwide and remains a leading cause of cancer-related mortality. Approximately 5% of patients present with distant metastases at diagnosis, while nearly 30% of early-stage patients later develop metastatic disease.
Although metastatic breast cancer remains incurable, the introduction of novel therapies has significantly extended patient survival. Treatment goals focus on prolonging survival and enhancing quality of life (QoL) through symptom management. Given disease heterogeneity, personalized treatment strategies are essential. HER2-negative breast cancer is characterized by tumor cells that do not overexpress the HER2 protein.

Emerging Drug Profiles in HER2-Negative Breast Cancer
Giredestrant - Genentech
Giredestrant is a next-generation oral selective estrogen receptor degrader (SERD) designed to target estrogen receptor signaling. As a new molecular entity, it demonstrates oral bioavailability and competitively blocks estrogen binding to the ER.
Preclinical data indicate that Giredestrant restricts both wild-type and mutant ER activity, suppressing downstream gene expression. The therapy is currently in Phase III development for HER2-negative breast cancer.

Inavolisib - Genentech
Inavolisib is an investigational small-molecule inhibitor selectively targeting mutant PI3Kα. Preclinical studies show enhanced potency against mutant PI3Kα compared to wild-type, with minimal activity against other PI3K isoforms.
By binding to the ATP-binding site, Inavolisib disrupts downstream signaling and selectively degrades mutant PI3Kα. The drug is presently in Phase III clinical trials.

CX-2009 (Praluzatamab Ravtansine) - CytomX Therapeutics
CX-2009 is a conditionally activated antibody-drug conjugate (ADC) targeting CD166 and linked to the cytotoxic agent DM4.
Developed using CytomX's Probody® platform, the ADC remains masked until activated in the tumor microenvironment. CX-2009 is currently undergoing Phase II clinical evaluation.

H3B-6545 - H3 Biomedicine
H3B-6545 is an oral selective estrogen receptor covalent antagonist (SERCA) designed for ER-positive, HER2-negative metastatic breast cancer.
As a first-in-class agent, it shows activity against both wild-type and mutant ERα, including forms resistant to standard therapies. The compound is in Phase II development.

RGT-419B - Regor Therapeutics
RGT-419B is a next-generation CDK inhibitor optimized for enhanced kinase selectivity.
Preclinical findings demonstrate strong suppression of ER-positive breast cancer cells resistant to CDK4/6 inhibitors, with improved efficacy when combined with SERDs or PI3K pathway inhibitors. The drug is currently in Phase I trials.

Gain in-depth insights into cutting-edge innovations across the HER2-Negative Breast Cancer pipeline. Explore DelveInsight's expert-led analysis today @ HER2-Negative Breast Cancer Unmet Needs - https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Insights Covered in the HER2-Negative Breast Cancer Pipeline Report
• Detailed company-level analysis of therapies under development for HER2-negative breast cancer
• Segmentation of drug candidates into early-, mid-, and late-stage development
• Overview of active and inactive (discontinued or dormant) projects
• Evaluation of pipeline drugs by development stage, route of administration, molecular type, target, and therapy approach
• Comprehensive review of strategic collaborations, licensing agreements, and financing activities influencing future market growth

Route of Administration Categories
• Oral
• Parenteral
• Intravitreal
• Subretinal
• Topical

Molecule Type Classification
• Monoclonal antibodies
• Peptides
• Polymers
• Small molecules
• Gene therapies

Download DelveInsight's latest report to obtain strategic intelligence on upcoming HER2-negative breast cancer therapies and market dynamics @ HER2-Negative Breast Cancer Market Drivers, Barriers, and Future Outlook - https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Scope of the HER2-Negative Breast Cancer Pipeline Report
• Geographic Coverage: Global
• Key Companies: Genentech, CytomX Therapeutics, H3 Biomedicine, Regor Therapeutics, and others
• Key Therapies: Doxorubicin, Cyclophosphamide, Utidelone + Bevacizumab, Capecitabine, Carboplatin, Cisplatin, and more
• Therapeutic Assessment: Mono, Combination, and Hybrid Therapies
• Development Stages: Discovery to Phase III

Discover which organizations are leading HER2-negative breast cancer drug innovation-access DelveInsight's exclusive pipeline report now @ HER2-Negative Breast Cancer Emerging Drugs and Key Companies - https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
• Introduction
• Executive Summary
• Disease Overview
• Pipeline Therapeutics
• Therapeutic Evaluation
• DelveInsight's Analytical Perspective
• Late-, Mid-, and Early-Stage Products
• Preclinical and Inactive Assets
• Key Companies and Products
• Unmet Needs
• Market Drivers, Barriers, and Future Outlook
• Analyst Insights
• Appendix
• About DelveInsight

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.