Triple Negative Breast Cancer Clinical Trials Assessment 2025: Competitive Landscape, FDA Approvals, Therapies, Emerging Drugs, Mechanism of Action, Route of Administration by DelveInsight

The prevalence of triple-negative breast cancer has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of triple-negative breast cancer and the growing research and development activities to develop novel therapies to treat TNBC to drive the market. The companies developing the potential therapies in the last stage of development include Jiangsu HengRui Medicine, G1 Therapeutics, Infinity Pharmaceuticals, etc.
(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 @ [https://www.delveinsight.com/report-store/triple-negative-breast-cancer-tnbc-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Key Takeaways from the Triple Negative Breast Cancer Pipeline Report

* In June 2025, Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced positive data from an investigator-initiated Phase 1b clinical trial evaluating onvansertib in combination with paclitaxel in patients with metastatic triple-negative breast cancer (mTNBC) at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30-June 3, 2025, in Chicago, Illinois.
* In June 2025, Cellectar Biosciences, Inc. (Nasdaq: CLRB ), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the company has submitted a protocol with the U.S. Food and Drug Administration (FDA) for a Phase 1b Dose Finding study of its Auger emitting radiopharmaceutical, CLR 125, for the treatment of relapsed TNBC. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, such as triple negative breast, lung and colorectal cancers.
* 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 G1 Therapeutics, Inc, Gilead Sciences, Biotheus Inc., GlaxoSmithKline, Hoffmann-La Roche, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Shanghai Escugen Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, Sichuan Baili Pharmaceutical, Novartis Pharmaceuticals, Akeso Biopharma, OBI Pharma, Shanghai Jiaolian Drug Research and Development Co., Ltd, Coherent Biopharma, Daiichi Sankyo Company/Merck, SynDevRx, Inc., Treadwell Therapeutics, Merck & Co, BeBetter Med, Tasly Biopharmaceuticals Co., Ltd., Ambrx, Eli Lilly and Company, Rhizen Pharmaceuticals, Roche, TJ Biopharma Co., Ltd., Prolynx, Merck Sharp & Dohme LLC, ES-102; Hexavalent OX40 agonist antibody, INBRX-106, Processa Pharmaceuticals, Oncolytics Biotech, OncoSec Medical Incorporated, PharmAbcine, JenKem Technology, MedSIR, Zenith Epigenetics, Astellas Pharma Inc, Intensity Therapeutics, Inc., NEC Corporation, Cardiff Oncology, Ocellaris Pharma, Inc., Nuvation Bio Inc., NeoImmuneTech, Scancell Ltd, Lantern Pharma Inc., Medicenna Therapeutics, Inc., Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Salubris Biotherapeutics Inc, Pfizer/Merck, Celcuity Inc., Jacobio Pharmaceuticals Co., Ltd., Immunitas Therapeutics, Innolake Biopharm, Hummingbird Bioscience, Hutchmed/BeiGene, Adagene Inc, Genmab, ProDa BioTech, Rapa Therapeutics LLC, Amgen, Strand Therapeutics Inc., Simcha Therapeutics, UCB, Sumitomo Pharma America, Inc., Shanghai Junshi Biosciences, Abbisko Therapeutics, Cytovation AS, CytosinLab Therapeutics Co., Ltd., Cantargia AB, BioAtla, Inc., BicycleTx Limited, Transgene, Bristol-Myers Squibb, BioLite, Inc., Bolt Biotherapeutics, Inc., Avenzo Therapeutics, Inc., Apollo Therapeutics Ltd, A2 Biotherapeutics Inc., Fusion Pharmaceuticals Inc., Volastra Therapeutics, Inc., Teon Therapeutics, Inc., TransThera Sciences (Nanjing), Inc., TCR2 Therapeutics, NeoTX Therapeutics Ltd., Phoenix Molecular Designs, Pure Biologics S.A., Mersana Therapeutics, Zumutor Biologics Inc., Xencor, Inc., Janux Therapeutics, Memgen, Inc., ModernaTX, Inc., Myeloid Therapeutics, Nanobiotix, NiKang Therapeutics, Inc., Numab Therapeutics AG, NextPoint Therapeutics, Inc., Nurix Therapeutics, Inc., Imugene Limited, OncoNano Medicine, Inc., Tizona Therapeutics, Inc, Theratechnologies, Exelixis, MBrace Therapeutics, LIGACHEM BIOSCIENCES Inc., Bellicum Pharmaceuticals, Compass Therapeutics, Circle Pharma, AbbVie, Adcentrx Therapeutics, Angiex, Inc., Precigen, Inc, Novartis, Laekna Limited, Light Chain Bioscience - Novimmune SA, BeiGene, SillaJen, Inc., Genentech, Inc., Accent Therapeutics, Arcus Biosciences, Inc., A2A Pharmaceuticals Inc., Adlai Nortye Biopharma Co., Ltd., Sichuan Baili Pharmaceutical Co., Ltd., Compugen Ltd, BioEclipse Therapeutics, Innate Pharma, ImmunoGenesis, Tubulis GmbH, Hinova pharmaceuticals, Repertoire Immune Medicines, VEANA THERAPEUTICS, Pharos iBio Co., Ltd., GeneQuantum Healthcare, Trio Pharmaceuticals, Cellectis, Rakovina Therapeutics, Pan Cancer T, Pinotbio, Starlight Therapeutics, Primevax, ARCE therapeutics, HC Biopharma, Casinvent, Speer Medical Technologies, Shengjing Hospital , others.
* Promising Triple Negative Breast Cancer Pipeline Therapies such as Trilaciclib, Sacituzumab Govitecan + Pembrolizumab, PM8002, Niraparib, Ipatasertib, FDA018-ADC, ESG401, Dato-DXd, Capivasertib, Camrelizumab, BL-B01D1, Alpelisib, AK112, Adagloxad Simolenin, Olaparib, B013+Nab-Paclitaxel, CBP-1008, Patritumab deruxtecan, Evexomostat, CFI-400945 + Durvalumab, Ceralasertib + Durvalumab/Nab-Paclitaxel, Carboplatin + Everolimus, Pembrolizumab and Carboplatin + Docetaxel, BEBT-209, B1962, ARX788, Bicalutamide + Abemaciclib, 9MW2821, Tenalisib, Tiragolumab, TJ107 + Pembrolizumab, Tobemstomig + Nab-Paclitaxel, PLX038, Pembrolizumab + Lenvatinib, INBRX-106 + Pembrolizumab, Vibostolimab + pembrolizumab, PCS6422 + Capecitabine, Alisertib + Paclitaxel, Pelareorep, Tavokinogene telseplasmid, Olinvacimab, JK-1201I, MEN1611, ZEN-3694, Enfortumab vedotin, INT230-6, NECVAX-NEO1, Onvansertib, OC-001, NUV-868, NT-I7, Modi-1, LP-184, MDNA11, KN046, JK08, ladiratuzumab vedotin, Gedatolisib+Talazoparib, JAB-2485, IMT-009, ILB-2109, HMBD-001, Fruquintinib+Tislelizumab, ADG106, PRO1107, ProAgio, Zimberelimab, RAPA-201, Talimogene laherparepvec, STX-001, ST-067, UCB4594, SMP3124LP, JS108, ABSK-081, CyPep-1, CTS2190, Nadunolimab, CAB-ROR2-ADC, BT8009, BT5528, BT-001, BMS-986449, BMS-986340, BLEX 404, Bemarituzumab, BDC-3042, AVZO-021, APL-5125, A2B395, FPI-1434, VLS-1488, Rina-S, TT-702, TT-00420, TC-510, Naptumomab Estafenatox, PMD-026, PBA-0405, PBA-0111, XMT-1660, ZM008, XmAb Registered 808, JANX008, LY4052031, LY4101174, LY4170156, MEM-288, mRNA-2752, MT-302, NBTXR3, NKT3447, NKT3964, NM32-2668, NPX267, NX-1607, CF33-hNIS-antiPDL1, ONM-501, TTX-080, TH1902, XB002, MBRC-101, CS5001, iC9-CAR.B7-H3 T Cell Therapy, HMBD-002, CTX-8371, CID-078, ABBV-400, ADRX-0706, AGX101, PRGN-3007, DKY709, LAE005, Boserolimab, NI-1801, BG-68501, BAL0891, Autogene Cevumeran, ATX-295, AB598, ABBV-927, AO-252, MK-5890, AN0025, [177Lu]Lu-NNS309, BL-M02D1, COM701, CRX100, IPH4502, IMGS-001, AZD8701, TUB-030, HP518, Tumor Associated Antigen, Dark Genome Antigen, VT101, PHI-501, PHI-101, CBP-8088, GQ1010, TROP2 TIE ADC, MUC1 CAR T-cells, KT-3000, PCT-1, PBX-001, STAR-001, PV001 DV, ARM 201, Research programme: ADC, Research programme: casein kinase 1 (CK1), KT-4000, DR-18621, SHR-1316, 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 @ [https://www.delveinsight.com/sample-request/triple-negative-breast-cancer-tnbc-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

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! @ [https://www.delveinsight.com/report-store/triple-negative-breast-cancer-tnbc-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Triple Negative Breast Cancer Companies

G1 Therapeutics, Inc, Gilead Sciences, Biotheus Inc., GlaxoSmithKline, Hoffmann-La Roche, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Shanghai Escugen Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, Sichuan Baili Pharmaceutical, Novartis Pharmaceuticals, Akeso Biopharma, OBI Pharma, Shanghai Jiaolian Drug Research and Development Co., Ltd, Coherent Biopharma, Daiichi Sankyo Company/Merck, SynDevRx, Inc., Treadwell Therapeutics, Merck & Co, BeBetter Med, Tasly Biopharmaceuticals Co., Ltd., Ambrx, Eli Lilly and Company, Rhizen Pharmaceuticals, Roche, TJ Biopharma Co., Ltd., Prolynx, Merck Sharp & Dohme LLC, ES-102; Hexavalent OX40 agonist antibody, INBRX-106, Processa Pharmaceuticals, Oncolytics Biotech, OncoSec Medical Incorporated, PharmAbcine, JenKem Technology, MedSIR, Zenith Epigenetics, Astellas Pharma Inc, Intensity Therapeutics, Inc., NEC Corporation, Cardiff Oncology, Ocellaris Pharma, Inc., Nuvation Bio Inc., NeoImmuneTech, Scancell Ltd, Lantern Pharma Inc., Medicenna Therapeutics, Inc., Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Salubris Biotherapeutics Inc, Pfizer/Merck, Celcuity Inc., Jacobio Pharmaceuticals Co., Ltd., Immunitas Therapeutics, Innolake Biopharm, Hummingbird Bioscience, Hutchmed/BeiGene, Adagene Inc, Genmab, ProDa BioTech, Rapa Therapeutics LLC, Amgen, Strand Therapeutics Inc., Simcha Therapeutics, UCB, Sumitomo Pharma America, Inc., Shanghai Junshi Biosciences, Abbisko Therapeutics, Cytovation AS, CytosinLab Therapeutics Co., Ltd., Cantargia AB, BioAtla, Inc., BicycleTx Limited, Transgene, Bristol-Myers Squibb, BioLite, Inc., Bolt Biotherapeutics, Inc., Avenzo Therapeutics, Inc., Apollo Therapeutics Ltd, A2 Biotherapeutics Inc., Fusion Pharmaceuticals Inc., Volastra Therapeutics, Inc., Teon Therapeutics, Inc., TransThera Sciences (Nanjing), Inc., TCR2 Therapeutics, NeoTX Therapeutics Ltd., Phoenix Molecular Designs, Pure Biologics S.A., Mersana Therapeutics, Zumutor Biologics Inc., Xencor, Inc., Janux Therapeutics, Memgen, Inc., ModernaTX, Inc., Myeloid Therapeutics, Nanobiotix, NiKang Therapeutics, Inc., Numab Therapeutics AG, NextPoint Therapeutics, Inc., Nurix Therapeutics, Inc., Imugene Limited, OncoNano Medicine, Inc., Tizona Therapeutics, Inc, Theratechnologies, Exelixis, MBrace Therapeutics, LIGACHEM BIOSCIENCES Inc., Bellicum Pharmaceuticals, Compass Therapeutics, Circle Pharma, AbbVie, Adcentrx Therapeutics, Angiex, Inc., Precigen, Inc, Novartis, Laekna Limited, Light Chain Bioscience - Novimmune SA, BeiGene, SillaJen, Inc., Genentech, Inc., Accent Therapeutics, Arcus Biosciences, Inc., A2A Pharmaceuticals Inc., Adlai Nortye Biopharma Co., Ltd., Sichuan Baili Pharmaceutical Co., Ltd., Compugen Ltd, BioEclipse Therapeutics, Innate Pharma, ImmunoGenesis, Tubulis GmbH, Hinova pharmaceuticals, Repertoire Immune Medicines, VEANA THERAPEUTICS, Pharos iBio Co., Ltd., GeneQuantum Healthcare, Trio Pharmaceuticals, Cellectis, Rakovina Therapeutics, Pan Cancer T, Pinotbio, Starlight Therapeutics, Primevax, ARCE therapeutics, HC Biopharma, Casinvent, Speer Medical Technologies, Shengjing Hospital , 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 @ [https://www.delveinsight.com/sample-request/triple-negative-breast-cancer-tnbc-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Scope of the Triple Negative Breast Cancer Pipeline Report

* Coverage- Global
* Triple Negative Breast Cancer Companies- 165+
* Triple Negative Breast Cancer Pipeline Therapies- 170+
* 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! @ [https://www.delveinsight.com/sample-request/triple-negative-breast-cancer-tnbc-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Table of Content

* Introduction
* Triple Negative Breast Cancer Executive Summary
* Triple Negative Breast Cancer: Overview
* Triple Negative Breast Cancer Pipeline Therapeutics
* Triple Negative Breast Cancer Therapeutic Assessment
* Triple Negative Breast Cancer - DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Camrelizumab: Jiangsu HengRui Medicine
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* AK117: Akeso Biopharma
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* PMD-026: Phoenix Molecular Designs
* Drug profiles in the detailed report.....
* Inactive Products
* Triple Negative Breast Cancer Companies
* Triple Negative Breast Cancer Products
* Triple Negative Breast Cancer Unmet Needs
* Triple Negative Breast Cancer Market Drivers and Barriers
* Triple Negative Breast Cancer Future Perspectives and Conclusion
* Triple Negative Breast Cancer Analyst Views
* Triple Negative Breast Cancer Key Companies
* Appendix

About Us

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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