ER+/ HER2 -ve Breast Cancer Pipeline

DelveInsight’s “ER+/HER2- Breast Cancer Pipeline Insight 2026” report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in ER+/HER2- 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

ER+/HER2- Breast Cancer Understanding

ER+/HER2- Breast Cancer Overview

ER+/HER2− Breast Cancer is the most common subtype of breast cancer, characterized by tumors that express estrogen receptors (ER-positive) but lack overexpression of the human epidermal growth factor receptor 2 (HER2-negative) protein. In this subtype, estrogen stimulates tumor growth, making hormone-based therapies particularly effective. ER+/HER2− cancers generally grow more slowly than other breast cancer types and often have a relatively favorable prognosis, especially when diagnosed early.
Signs and symptoms may include a lump or thickening in the breast or underarm, changes in breast size or shape, skin dimpling, nipple discharge, redness or scaling of the breast skin, and persistent breast pain. However, in many cases the disease may not cause noticeable symptoms in its early stages, which is why routine screening plays a critical role in early detection. Several risk factors are associated with ER+/HER2− breast cancer. These include increasing age, family history of breast cancer, inherited genetic mutations such as BRCA or BRCA2, prolonged exposure to estrogen (early menstruation or late menopause), obesity, alcohol consumption, and certain lifestyle factors. Hormone replacement therapy and reproductive history may also influence risk.

Genomic alterations, such as PIK3CA mutations, CCND1 amplification, ESR1 mutations, and aberrations in TP53 or DNA repair genes, further reshape the signaling landscape and underpin mechanisms of endocrine resistance and metastatic potential. These alterations are particularly prevalent in the more aggressive luminal B–like ER+/HER2− tumors and in relapsed disease, where they sustain cellular proliferation and survival despite prior endocrine therapy. In parallel, microenvironmental influences including cancer-associated fibroblasts, immune infiltrates, and bone stroma interact with tumor cells through growth factors and cytokines to enhance survival and promote therapeutic escape. Such interactions create a microenvironment conducive to bone homing and colonization, consistent with the observation that bone is the most common site of metastasis in ER+/HER2− breast cancer and highlighting the importance of bone-targeted interventions in advanced disease.

Diagnosis typically involves a combination of imaging and laboratory tests. Screening methods include mammography, breast ultrasound, and magnetic resonance imaging (MRI). If an abnormality is detected, a biopsy is performed to confirm the presence of cancer and to determine receptor status (ER, progesterone receptor, and HER2). Additional tests such as immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) help identify the molecular subtype, which guides treatment decisions.
Treatment for ER+/HER2− breast cancer typically involves a combination of approaches depending on disease stage and patient characteristics. Surgery (lumpectomy or mastectomy) is often the primary treatment, followed by radiation therapy when appropriate. Because the tumor is hormone-driven, endocrine therapies such as tamoxifen or aromatase inhibitors are commonly used to block estrogen signaling. In advanced or metastatic cases, targeted therapies such as CDK4/6 inhibitors may be combined with hormone therapy to improve outcomes. Chemotherapy may also be recommended in certain higher-risk cases.

"ER+/HER2- Breast Cancer Pipeline Insight 2026" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the ER+/HER2- Breast Cancer pipeline landscape is provided which includes the disease overview and ER+/HER2- Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth ER+/HER2- 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, ER+/HER2- Breast Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Discover the latest ER+/HER2- Breast Cancer pipeline insights, emerging therapies, and clinical advancements shaping the future of treatment in 2026.

ER+/HER2- Breast Cancer Pipeline Report Highlights

• The ER+/HER2- Breast Cancer Pipeline companies and academics are working to assess challenges and seek opportunities that could influence ER+/HER2- Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve ER+/HER2- Breast Cancer.

ER+/HER2- Breast Cancer Emerging Drugs Analysis

This segment of the ER+/HER2- Breast Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, 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.

ER+/HER2- Breast Cancer Emerging Drugs

AZD9833: AstraZeneca

Camizestrant is a next-generation oral selective estrogen receptor degrader (SERD) and pure estrogen receptor antagonist designed to fully degrade ERα and overcome resistance associated with ESR1 mutations. In early-phase studies (SERENA‑1/2), camizestrant showed favorable tolerability and clinical activity—alone or with CDK4/6 inhibitors—across both ESR1-mutant and wild-type HR⁺/HER2⁻ advanced breast cancer. The pivotal Phase III SERENA‑6 trial, which identified emerging ESR1 mutations via liquid biopsy before disease progression, demonstrated that switching to camizestrant combined with a CDK4/6 inhibitor significantly extended progression-free survival (median 16 months vs. 9.2 months), reducing the risk of progression or death by ~56%, with no new safety concerns.  Currently the drug is in Phase III stage of development for the treatment of 1st-line HR+ HER2- ESR1m breast cancer.  

Iza-bren: Bristol-Myers Squibb

Iza-bren (Izalontamab brengitecan; BL-B01D1) is a first-in-class bispecific antibody-drug conjugate (ADC) targeting EGFR and HER3, designed for advanced solid tumors including ER+/HER2- breast cancer, linked to a topoisomerase I inhibitor payload (Ed-04) via a cleavable linker that internalizes upon binding tumor cell surface receptors, releasing the cytotoxic payload to induce DNA damage and apoptosis. The drug is currently being evaluated under Phase II/III clinical trial for the treatment of patients with ER+/HER2- breast cancer.

STAR0602: Marengo Therapeutics

STAR0602 (invikafusp alfa), developed by Marengo Therapeutics, is a first-in-class, clinical-stage bi-functional fusion protein immunotherapy that uniquely targets specific variable (Vβ) regions of the T cell receptor (TCR) found on defined T cell subsets. Its novel mechanism of action involves simultaneous binding to the TCR Vβ region and delivering a co-stimulatory activation signal within the same T cell, leading to the selective expansion and activation of effector memory Vβ T cells capable of generating durable, tumor-directed immune responses. Unlike conventional T cell therapies that rely on clonal expansion or antigen-specific targeting, STAR0602 employs a non-clonal activation strategy, enabling it to bypass mechanisms of resistance to PD-1 inhibitors. According to the company’s pipeline, the drug is in Phase II stage of its development for the treatment of HR+, HER2-, Advanced Breast Cancer.

AVZO-023: Avenzo Therapeutics, Inc.

AVZO-023 is an investigational, highly potent and selective CDK4 inhibitor being developed by Avenzo Therapeutics for the treatment of HR-positive/HER2-negative breast cancer. It is designed to precisely target CDK4-driven cell-cycle dysregulation, a key mechanism underlying tumor growth in hormone receptor–positive disease. The drug aims to provide a next-generation, more selective CDK-targeted therapy to improve outcomes in endocrine-resistant disease. AVZO-023 is currently being evaluated in a Phase I/II clinical study, including combination regimens for patients with advanced or metastatic HR+/HER2- breast cancer.

BGB-21447: BeOne Medicines

BGB-21447 is highly potent and selective BCL2 inhibitor (a drug that selectively stops a protein called B-cell lymphoma-2 (BCL2)). BCL2 proteins are often overexpressed in some cancers including 70% overexpression in HR+ breast cancer. The combination of BGB-21447 with endocrine therapy (ET) ± a selective CDK4i is hypothesized to have therapeutic potential for meaningful clinical benefit in patients with HR+/HER2- breast cancer. Currently the drug is in Phase I stage of its development for the treatment of HR+/HER2- breast cancer.

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

ER+/HER2- Breast Cancer: Therapeutic Assessment

This ER+/HER2- Breast Cancer segment of the report provides insights about the different ER+/HER2- Breast Cancer drugs segregated based on following parameters that define the scope of the report, such as:

Major  Players in ER+/HER2- Breast Cancer

• There are approx. 75+ key companies which are developing the therapies for ER+/HER2- Breast Cancer. The companies which have their ER+/HER2- Breast Cancer drug candidates in the most advanced stage, i.e. Phase III include, AstraZeneca

Phases

DelveInsight’s report covers around 80+ 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

ER+/HER2- Breast Cancer Route of Administration

ER+/HER2- 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 

• Oral
• Intravenous
• Subcutaneous
• Parenteral 
• Topical

ER+/HER2- Breast Cancer Molecule Type

ER+/HER2- Breast Cancer Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer 
• Gene therapy

ER+/HER2- Breast Cancer Product Type

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

ER+/HER2- Breast Cancer Clinical Trials Activities 

The ER+/HER2- Breast Cancer Pipeline report provides insights into ER+/HER2- Breast Cancer Clinical Trials in Phase III, II, I, preclinical and discovery stage. It also analyses ER+/HER2- Breast Cancer therapeutic drugs key players involved in developing key drugs. 

ER+/HER2- Breast Cancer Pipeline Development Activities 

The ER+/HER2- Breast Cancer Clinical Trials analysis report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging ER+/HER2- Breast Cancer drugs.

ER+/HER2- Breast Cancer Report Insights

• ER+/HER2- Breast Cancer Pipeline Analysis
• ER+/HER2- Breast CancerTherapeutic Assessment
• ER+/HER2- Breast Cancer Market Unmet Needs
• Impact of ER+/HER2- Breast Cancer Drugs

ER+/HER2- Breast Cancer Report Assessment

• ER+/HER2- Breast Cancer Pipeline Product Profiles
• ER+/HER2- Breast Cancer Therapeutic Assessment
• ER+/HER2- Breast Cancer Pipeline Assessment
• Inactive ER+/HER2- Breast Cancer drugs assessment
• ER+/HER2- Breast Cancer Market Unmet Needs

Discover actionable insights into the ER+/HER2- Breast Cancer market trends, epidemiology trends, and forecast through 2036 to stay ahead in emerging therapies.

Key Questions Answered in the ER+/HER2- Breast Cancer Pipeline ReportCurrent Treatment Scenario and Emerging Therapies:

• How many ER+/HER2- Breast Cancer companies are developing ER+/HER2- Breast Cancer drugs?

• How many ER+/HER2- Breast Cancer drugs are developed by each company?

• How many ER+/HER2- Breast Cancer emerging drugs are in mid-stage, and late-stage of development for the treatment of ER+/HER2- Breast Cancer?

• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the ER+/HER2- 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 ER+/HER2- Breast Cancer and their status?

• What are the key designations that have been granted to the ER+/HER2- Breast Cancer emerging drugs?

ER+/HER2- Breast Cancer Key Players

• AstraZeneca

• Bristol-Myers Squibb

• Marengo Therapeutics

• Avenzo Therapeutics, Inc.

• BeOne Medicines

• Hoffmann-La Roche

• Ellipses Pharma

• TYK Medicine

• Recursion Pharmaceuticals

• Kind Pharmaceuticals LLC

• Sanofi

• Merck Sharp & Dohme Corp

   

ER+/HER2- Breast Cancer Key Products

• AZD9833

• Iza-bren

• STAR0602

• AVZO-023

• BGB-21447

• Giredestrant

• Vosilasarm (EP0062)

• TYK-00540

• GTAEXS617

• AND019

• BLU956

• Belzutifan

Explore comprehensive insights into ER+/HER2- Breast Cancer epidemiology trends, patient population forecasts, and growth opportunities through 2034 for strategic decision-making.