Triple Negative Breast Cancer Pipeline

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

 

Geography Covered

• Global coverage

 

Triple Negative Breast Cancer: Understanding

Triple Negative Breast Cancer: Overview

Triple Negative Breast Cancer (TNBC) is defined as a tumor where the estrogen and progesterone (ER/PR)  are negative, as assessed by immunohistochemistry (IHC), and there is a lack of overexpression of HER2, as assessed by immunohistochemistry (IHC), or the absence of its gene amplification, as assessed by fluorescence in situ hybridization technique. The epidemiological risk factor profiles also vary between TNBC (ER-PR-HER2-) and other breast cancers.  TNBCs are frequently identified as hyper dense masses without associated calcifications. The majority of TNBCs are histologically classified as high-grade, invasive, ductal carcinomas of no special type with basal-like features. Central necrosis, pushing tumor borders, a conspicuous lymphocytic infiltrate, and fibrosis are common histologic features. 

 

The most common symptom of breast cancer is a new lump or mass (although most breast lumps are not cancer). A painless, hard mass that has irregular edges is more likely to be cancer, but breast cancers can be also soft, round, tender, or even painful. Other possible symptoms of breast cancer include swelling of all or part of a breast (even if no lump is felt) skin dimpling (sometimes looking like an orange peel), breast or nipple pain, nipple retraction (turning inward), nipple or breast skin that is red, dry, flaking, or thickened, nipple discharge (other than breast milk), swollen lymph nodes under the arm or near the collar bone. 

 

Triple-negative breast cancer (TNBC) pathophysiology involves the absence of estrogen receptors (ER), progesterone receptors (PR), and HER2 protein, leading to a lack of response to hormonal and HER2-targeted therapies. TNBC is often associated with genetic mutations, particularly in the BRCA1 and BRCA2 genes. The aggressive nature of TNBC is due to its rapid growth and higher propensity for metastasis. Molecular pathways involved include basal-like, mesenchymal, and immune-inflammatory processes, contributing to its complex behavior and resistance to standard treatments. Triple-negative breast cancer (TNBC) is a subtype of breast cancer characterized by the absence of estrogen receptors, progesterone receptors, and minimal HER2 protein expression. This makes TNBC unresponsive to some of the common hormonal therapies used for other breast cancers. TNBC tends to be more aggressive and has a higher likelihood of recurrence compared to other breast cancer types. Treatment options typically include a combination of surgery, chemotherapy, and radiation therapy. Early diagnosis and tailored treatment are crucial for improving outcomes. 

 

Triple-negative breast cancer has fewer treatment options than other types of invasive breast cancer. This is because the cancer cells do not have the estrogen or progesterone receptors or enough of the HER2 protein to make hormone therapy or targeted HER2 drugs work. Because hormone therapy and anti-HER2 drugs are not choices for women with triple-negative breast cancer, chemotherapy is often used. If the cancer has not spread to distant sites, surgery is an option. Chemotherapy might be given first to shrink a large tumor, followed by surgery. Chemotherapy is often recommended after surgery to reduce the chances of the cancer coming back. Radiation might also be an option depending on certain features of the tumor and the type of surgery patient had. In cases where the cancer has spread to other parts of the body (stage IV), platinum chemotherapy, targeted drugs like a PARP inhibitor or antibody-drug conjugate, or immunotherapy with chemotherapy might be considered. 

 

"Triple Negative Breast Cancer- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Triple Negative Breast Cancer pipeline landscape is provided which includes the disease overview and Triple Negative Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth Triple Negative Breast Cancer commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Triple Negative Breast Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Triple Negative Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve Triple Negative Breast Cancer. 

 

Triple Negative Breast Cancer Emerging Drugs Chapters

This segment of the Triple Negative Breast Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

 

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.

Further product details are provided in the report……..

 

Triple Negative Breast Cancer: Therapeutic Assessment

This segment of the report provides insights about the different Triple Negative Breast Cancer drugs segregated based on following parameters that define the scope of the report, such as:

Major  Players in Triple Negative Breast Cancer

There are approx. 165+ key companies which are developing the therapies for Triple Negative Breast Cancer. The companies which have their Triple Negative Breast Cancer drug candidates in the most advanced stage, i.e. Phase III include, G1 Therapeutics, Inc.

 

Phases

DelveInsight’s report covers around 170+ 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

 

Route of Administration

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

 

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

 

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

 

Triple Negative Breast Cancer: Pipeline Development Activities 

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Triple Negative Breast Cancer therapeutic drugs key players involved in developing key drugs. 

 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Triple Negative Breast Cancer drugs.

 

Triple Negative Breast Cancer Report Insights

• Triple Negative Breast Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

 

Triple Negative Breast Cancer Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Triple Negative Breast Cancer drugs?
• How many Triple Negative Breast Cancer drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Triple Negative Breast Cancer?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Triple Negative Breast Cancer therapeutics? 
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? 
• What are the clinical studies going on for Triple Negative Breast Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

 

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