Triple Negative Breast Cancer Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, Route of Administration, and Companies by DelveInsight

Triple Negative Breast Cancer Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, Route of Administration, and Companies by DelveInsight
Triple Negative Breast Cancer Clinical Trials
Triple Negative Breast Cancer Companies are G1 Therapeutics, Inc, Gilead Sciences, Biotheus Inc., GlaxoSmithKline, AstraZeneca, Shanghai Jiaolian Drug Research and Development Co., Ltd, Coherent Biopharma, Daiichi Sankyo Company/Merck, SynDevRx, Inc., Treadwell Therapeutics, Novartis Pharmaceuticals, NEC Corporation, Cardiff Oncology, Ocellaris Pharma, Inc., Nuvation Bio Inc., Phoenix Molecular Designs, Pure Biologics S.A., Mersana Therapeutics, Zumutor Biologics Inc., Tubulis GmbH, more

(Albany, USA) DelveInsight’s “Triple Negative Breast Cancer Pipeline Insight 2025” report provides comprehensive insights about 165+ companies and 170+ pipeline drugs in the Triple Negative Breast Cancer pipeline landscape. It covers the Triple Negative Breast Cancer Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Triple Negative Breast Cancer pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

As per DelveInsight, the Triple Negative Breast Cancer therapeutics market is anticipated to evolve immensely in the coming years owing to the increasing incident population of TNBC patients, the improvement in the diagnosis methodologies, rising awareness of the disease, incremental healthcare spending worldwide, and the launch of new therapies in the market.

Upcoming therapies, such as TECENTRIQ (Hoffmann-La Roche), IPI-549 (Infinity Pharmaceuticals), Leronlimab (CytoDyn), MDNA11 (Medicenna Therapeutics), VIP236 (Vincerx Pharma), and CFI-400945 (Treadwell Therapeutics), and others, have the potential to create a significant positive shift in the TNBC market size and the treatment scenario.

 

To know more about the TNBC pipeline Report offerings and trends, request for a free sample report @ Triple Negative Breast Cancer Drug Pipeline Analysis

 

Key Takeaways from the Triple Negative Breast Cancer Pipeline Report

  • In May 2025, AstraZeneca announced a phase III study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple negative Breast Cancer (TNBC).
  • In May 2025, MedSIR announced a phase II clinical trial that is designed to improve the tolerance of sacituzumab govitecan in patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC), refractory to at least one, and no more than two, prior standard of care chemotherapy regimens in this setting that is not amenable to resection with curative intent.
  • In May 2025, Merck Sharp & Dohme LLC conducted a study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician’s choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery.
  • DelveInsight’s Triple Negative Breast Cancer Pipeline analysis depicts a robust space with 165+ active players working to develop 170+ pipeline treatment therapies.
  • The leading Triple Negative Breast Cancer Companies such as Shanghai Henlius Biotech, Jiangsu HengRui Medicine Co., Ltd., G1 Therapeutics, Inc., Infinity Pharmaceuticals, HiberCell, Inc., Zenith Epigenetics, BioLite, Inc., Abbisko Therapeutics, Phoenix Molecular Designs, OncoTherapy Science, ModernaTX, Inc, and others.
  • Promising Triple Negative Breast Cancer Pipeline Therapies such as Nanosomal Docetaxel Lipid Suspension (75 mg/m2), Taxotere® (100 mg/m2), B013+Nab-Paclitaxel, ZEN003694, Talazoparib, Pembrolizumab, Sacituzumab Govitecan-hziy, Datopotamab Deruxtecan (Dato-DXd), and others.

 

Stay ahead with the most recent pipeline outlook for Triple Negative Breast Cancer. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Triple Negative Breast Cancer Treatment Drugs

 

Triple Negative Breast Cancer Emerging Drugs

  • Trilaciclib: G1 Therapeutics, Inc.

TofaciTrilaciclib, a transient IV-administered CDK4/6 inhibitor, is a novel therapeutic approach which is given before chemotherapy that temporarily blocks progression through the cell cycle. This provides two potential benefits firstly bone marrow protection and therefore the immune system from damage caused by cytotoxic therapy, and secondly improved long term immune surveillance by upregulating the formation of certain memory T cells. Trilaciclib is being evaluated a number of tumor types and chemotherapy regimens to assess its potential myeloprotection, antitumor efficacy and safety in combination with cytotoxic therapies and other anticancer agents. Currently, the drug is in the Phase III stage of its development for the treatment of Triple Negative Breast Cancer.

 

  • Olaparib: AstraZeneca

Olaparib is an oral PARP inhibitor developed by AstraZeneca, approved for BRCA-mutated triple-negative breast cancer (TNBC). It works by blocking PARP enzymes, preventing DNA repair in cancer cells, leading to cell death, particularly in BRCA1/2-mutant tumors. The OlympiAD trial showed that Olaparib significantly improved progression-free survival (PFS) compared to chemotherapy in metastatic TNBC. It is FDA-approved for germline BRCA-mutated, HER2-negative breast cancer and is being explored in combination with immunotherapy and chemotherapy for broader TNBC treatment. Currently, the drug is in the Phase II/III stage of its development for the treatment of Triple Negative Breast Cancer.

 

  • Patritumab Deruxtecan: Daiichi Sankyo Company/Merck

Patritumab deruxtecan (HER3-DXd) is an investigational HER3-directed antibody–drug conjugate (ADC) developed by Daiichi Sankyo. It comprises a fully human anti-HER3 monoclonal antibody linked to a topoisomerase I inhibitor payload via a tumor-selective cleavable linker. HER3 is frequently overexpressed in triple-negative breast cancer (TNBC), correlating with poorer prognosis. In a phase 1/2 trial, patritumab deruxtecan demonstrated promising clinical activity in patients with HER3-expressing metastatic breast cancer. Currently, the drug is in the Phase II stage of its development for the treatment of Triple Negative Breast Cancer.

 

  • NUV-868: Nuvation Bio Inc.

NUV-868 is an experimental drug being studied alone and in combination with PARP inhibitors for the treatment of advanced solid tumors, including triple-negative breast cancer (TNBC). Nuvation Bio had decided not to initiate a Phase II study of NUV-868 as a monotherapy or in combination with olaparib or enzalutamide in the advanced solid tumor indications that were part of the Phase I and Phase Ib study designs. The Company is evaluating next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients. Currently, the drug is in the Phase I/II stage of its development for the treatment of Triple Negative Breast Cancer.

 

  • TUB-030: Tubulis

TUB-030 is an antibody drug conjugate directed against 5T4, an oncofetal antigen, expressed in a broad range of solid tumor types. It consists of an IgG1 antibody targeting 5T4 connected to the Topoisomerase I inhibitor exatecan through a cleavable linker system based on the company’s proprietary P5 conjugation technology with a homogeneous DAR of 8. P5 conjugation is a novel chemistry for cysteine-selective conjugation that enables ADC generation with unprecedented linker stability and biophysical properties. Currently the drug is in Preclinical stage of its development for the treatment of TNBC.

 

The Triple Negative Breast Cancer Pipeline report provides insights into

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

 

Explore groundbreaking therapies and clinical trials in the Triple Negative Breast Cancer Pipeline. Access DelveInsight’s detailed report now! @ New Triple Negative Breast Cancer Drugs

 

Triple Negative Breast Cancer Companies

Shanghai Henlius Biotech, Jiangsu HengRui Medicine Co., Ltd., G1 Therapeutics, Inc., Infinity Pharmaceuticals, HiberCell, Inc., Zenith Epigenetics, BioLite, Inc., Abbisko Therapeutics, Phoenix Molecular Designs, OncoTherapy Science, ModernaTX, Inc, and others.

 

Triple 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

  • Intravenous
  • Subcutaneous
  • Oral
  • Intramuscular

 

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

  • Monoclonal antibody
  • Small molecule
  • Peptide

 

Unveil the future of Triple Negative Breast Cancer Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Triple Negative Breast Cancer Market Drivers and Barriers

 

Scope of the Triple Negative Breast Cancer Pipeline Report

  • Coverage- Global
  • Triple Negative Breast Cancer Companies- Shanghai Henlius Biotech, Jiangsu HengRui Medicine Co., Ltd., G1 Therapeutics, Inc., Infinity Pharmaceuticals, HiberCell, Inc., Zenith Epigenetics, BioLite, Inc., Abbisko Therapeutics, Phoenix Molecular Designs, OncoTherapy Science, ModernaTX, Inc, and others.
  • Triple Negative Breast Cancer Pipeline Therapies- Nanosomal Docetaxel Lipid Suspension (75 mg/m2), Taxotere® (100 mg/m2), B013+Nab-Paclitaxel, ZEN003694, Talazoparib, Pembrolizumab, Sacituzumab Govitecan-hziy, Datopotamab Deruxtecan (Dato-DXd), and others.
  • Triple Negative Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Triple Negative Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

 

Get the latest on Triple Negative Breast Cancer Therapies and clinical trials. Download DelveInsight’s in-depth pipeline report today! @ Triple Negative Breast Cancer Companies, Key Products and Unmet Needs

 

Table of Content

  1. Introduction
  2. Triple Negative Breast Cancer Executive Summary
  3. Triple Negative Breast Cancer: Overview
  4. Triple Negative Breast Cancer Pipeline Therapeutics
  5. Triple Negative Breast Cancer Therapeutic Assessment
  6. Triple Negative Breast Cancer – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Camrelizumab: Jiangsu HengRui Medicine
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. AK117: Akeso Biopharma
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. PMD-026: Phoenix Molecular Designs
  15. Drug profiles in the detailed report…..
  16. Inactive Products
  17. Triple Negative Breast Cancer Companies
  18. Triple Negative Breast Cancer Products
  19. Triple Negative Breast Cancer Unmet Needs
  20. Triple Negative Breast Cancer Market Drivers and Barriers
  21. Triple Negative Breast Cancer Future Perspectives and Conclusion
  22. Triple Negative Breast Cancer Analyst Views
  23. Triple Negative Breast Cancer Key Companies
  24. Appendix

 

About DelveInsight

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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