HER2 Negative Metastatic Breast Cancer Clinical Trials

DelveInsight reports that over 50 key companies are actively developing more than 50 therapeutic candidates for HER2-negative metastatic breast cancer.

HER2 Negative Metastatic Breast Cancer Overview:

Breast cancer is the most prevalent cancer among women worldwide and remains a leading cause of mortality. At diagnosis, about 5% of patients present with distant metastases, while roughly 30% of early-stage cases eventually progress to metastatic disease. Although metastatic breast cancer cannot be completely cured, advances in therapy have considerably improved survival rates and quality of life (QoL). Treatment primarily aims to prolong survival and manage symptoms, with strategies tailored to each patient rather than using a uniform approach.

HER2-negative breast cancer is a subtype in which cancer cells do not overexpress the HER2 protein, a key factor in cell growth. It is further divided based on hormone receptor (HR) status. HR-positive breast cancer, accounting for 50–70% of cases, depends on hormones like estrogen or progesterone for growth. Triple-negative breast cancer (TNBC) lacks both HER2 and hormone receptors, making it more challenging to treat.

For HER2-negative metastatic breast cancer, the focus is on disease management rather than cure, aiming to extend survival and improve QoL. Standard treatments include:

• Hormonal (endocrine) therapy, which blocks estrogen effects to slow tumor growth and generally causes fewer side effects than chemotherapy.

• Chemotherapy, used alone or in combination with other drugs to destroy cancer cells.

• Targeted therapy (precision medicine), an emerging approach that inhibits specific molecules driving cancer progression.

In addition to active treatment, palliative care can help manage pain, anxiety, and other symptoms associated with advanced breast cancer. Because metastatic disease affects patients differently, personalized treatment plans are essential to optimize outcomes and enhance overall well-being.

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“HER2 Negative Metastatic Breast Cancer Pipeline Insight 2025” report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the HER2 Negative Metastatic Breast Cancer Therapeutics Market.

Key Takeaways from the HER2 Negative Metastatic Breast Cancer Pipeline Report

• DelveInsight’s HER2-Negative Metastatic Breast Cancer (MBC) pipeline report highlights a vibrant landscape with over 50 companies developing more than 50 therapeutic candidates for HER2-negative MBC.

• In March 2025, the VERITAC-2 trial showed that vepdegestrant (ARV-471) significantly improved progression-free survival compared to fulvestrant in patients with ER-positive, HER2-negative advanced or metastatic breast cancer harboring ESR1 mutations, underscoring its potential as a promising therapy pending further evaluation and FDA approval.

• In January 2025, the FDA approved datopotamab deruxtecan-dlnk (Datroway) for adult patients with unresectable or metastatic, HR-positive, HER2-negative breast cancer who had previously received endocrine therapy and chemotherapy. This approval was supported by the TROPION-Breast01 trial, which demonstrated significant efficacy in this population.

• In October 2024, the FDA approved inavolisib in combination with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer, based on results from the INAVO120 trial showing notable efficacy.

• Key players such as BeiGene, Context Therapeutics, Astex Pharmaceuticals, Eisai Inc., AstraZeneca, Dantari, Inc., and others are actively advancing new therapies to enhance the HER2-negative MBC treatment landscape.

• Promising pipeline candidates in various stages include Pamiparib, Onapristone, and others.

HER2 Negative Metastatic Breast Cancer Pipeline Analysis

The report provides insights into:

• The report provides detailed insights into the key companies that are developing therapies in the HER2 Negative Metastatic Breast Cancer Market.

• The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for HER2 Negative Metastatic Breast Cancer treatment.

• It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• It navigates the emerging 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.

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HER2 Negative Metastatic Breast Cancer Emerging Drugs

• Pamiparib: BeiGene

• Onapristone: Context Therapeutics

HER2 Negative Metastatic Breast Cancer Companies

Over 50 major pharmaceutical companies are actively developing therapies for HER2-negative metastatic breast cancer, with BeiGene advancing the most progressed candidate, currently in Phase II clinical trials.

DelveInsight’s report covers around 50+ 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 Metastatic 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

• Intravenous

• Subcutaneous

• Oral

• Intramuscular

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

• Monoclonal antibody

• Small molecule

• Peptide

Download Sample Pages to Get an in-depth Assessment of the Emerging HER2 Negative Metastatic Breast Cancer Therapies and Key Companies: HER2 Negative Metastatic Breast Cancer Clinical Trials and advancements

HER2 Negative Metastatic Breast Cancer Pipeline Therapeutic Assessment

• HER2 Negative Metastatic Breast Cancer Assessment by Product Type

• HER2 Negative Metastatic Breast Cancer By Stage

• HER2 Negative Metastatic Breast Cancer Assessment by Route of Administration

• HER2 Negative Metastatic Breast Cancer Assessment by Molecule Type

Download HER2 Negative Metastatic Breast Cancer Sample report to know in detail about the HER2 Negative Metastatic Breast Cancer treatment market @ HER2 Negative Metastatic Breast Cancer Therapeutic Assessment

Table of Content

1. Report Introduction

2. Executive Summary

3. HER2 Negative Metastatic Breast Cancer Current Treatment Patterns

4. HER2 Negative Metastatic Breast Cancer – DelveInsight’s Analytical Perspective

5. Therapeutic Assessment

6. HER2 Negative Metastatic Breast Cancer Late-Stage Products (Phase-III)

7. HER2 Negative Metastatic Breast Cancer Mid-Stage Products (Phase-II)

8. Early Stage Products (Phase-I)

9. Pre-clinical Products and Discovery Stage Products

10. Inactive Products

11. Dormant Products

12. HER2 Negative Metastatic Breast Cancer Discontinued Products

13. HER2 Negative Metastatic Breast Cancer Product Profiles

14. HER2 Negative Metastatic Breast Cancer Key Companies

15. HER2 Negative Metastatic Breast Cancer Key Products

16. Dormant and Discontinued Products

17. HER2 Negative Metastatic Breast Cancer Unmet Needs

18. HER2 Negative Metastatic Breast Cancer Future Perspectives

19. HER2 Negative Metastatic Breast Cancer Analyst Review

20. Appendix

21. Report Methodology

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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.

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