ER positive, HER2 negative Breast Cancer- Pipeline Insight, 2025

DelveInsight’s, “ER positive, HER2 negative Breast Cancer- Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in ER positive, HER2 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

ER positive, HER2 negative Breast Cancer: Understanding

ER positive, HER2 negative Breast Cancer: Overview

ER-positive, HER2-negative breast cancer is a subtype of breast cancer characterized by cancer cells that have receptors for the hormone estrogen (ER-positive) but do not have excess amounts of the human epidermal growth factor receptor 2 (HER2-negative). This subtype is among the most common types of breast cancer, often affecting women post-menopause but can also occur in younger women. The presence of estrogen receptors means that the cancer cells grow in response to the hormone estrogen. The signs and symptoms of ER-positive, HER2-negative breast cancer are similar to those of other types of breast cancer. Common symptoms include a new lump or mass in the breast, changes in the size or shape of the breast, nipple discharge that is not breast milk, and changes to the skin over the breast, such as dimpling. Some women may experience pain in the breast or nipple. However, it's important to note that early stages of breast cancer may not present any noticeable symptoms, underscoring the importance of regular screening.

The exact causes of ER-positive, HER2-negative breast cancer are not fully understood, but several risk factors have been identified. Hormonal factors play a significant role, particularly prolonged exposure to estrogen. This can be influenced by factors such as early menstruation, late menopause, and hormone replacement therapy. Other risk factors include age, family history of breast cancer, genetic mutations (such as BRCA1 and BRCA2), and lifestyle factors like alcohol consumption and obesity. The interplay between genetic predisposition and environmental factors is complex and continues to be an area of active research.

Diagnosis of ER-positive, HER2-negative breast cancer typically involves a combination of imaging tests and biopsy procedures. Mammography is the most common initial screening tool, often followed by ultrasound or MRI if more detail is needed. A biopsy, where a sample of breast tissue is taken, is essential for confirming the diagnosis and determining the specific characteristics of the cancer, including its hormone receptor status and HER2 status. Immunohistochemistry (IHC) tests are used to detect the presence of estrogen and HER2 receptors, providing critical information for planning treatment.Treatment for ER-positive, HER2-negative breast cancer often involves a combination of surgery, radiation, and systemic therapies. Surgery may include lumpectomy or mastectomy, depending on the size and location of the tumor. Radiation therapy is commonly used after surgery to eliminate any remaining cancer cells. Systemic therapies play a key role and typically include hormone therapy, such as tamoxifen or aromatase inhibitors, which block the cancer’s ability to use estrogen. Chemotherapy may also be used, especially if the cancer is high-grade or has spread to lymph nodes. Targeted therapies and novel treatments are continually being developed and evaluated in clinical trials, offering hope for improved outcomes.

""ER positive, HER2 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 ER positive, HER2 negative Breast Cancer pipeline landscape is provided which includes the disease overview and ER positive, HER2 negative Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth ER positive, HER2 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, ER positive, HER2 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 ER positive, HER2 negative Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve ER positive, HER2 negative Breast Cancer.

ER positive, HER2 negative Breast Cancer Emerging Drugs Chapters

This segment of the ER positive, HER2 negative Breast Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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 positive, HER2 negative Breast Cancer Emerging Drugs

• Camizestrant: AstraZeneca

Camizestrant, is a next-generation oral selective estrogen receptor degrader (SERD), as a promising treatment for ER-positive, HER2-negative breast cancer. This drug, developed by AstraZeneca, and has shown significant potential in improving progression-free survival (PFS) compared to the standard treatment with fulvestrant, which has been the mainstay therapy for almost two decades. Camizestrant has demonstrated significant efficacy in clinical trials, particularly the SERENA-2 phase II trial. In this study, camizestrant was compared to fulvestrant, a well-established treatment. Patients receiving camizestrant showed improved progression-free survival (PFS) at doses of 75 mg and 150 mg, with median PFS of 7.2 and 9.2 months, respectively, compared to 3.7 months for those on fulvestrant. This trial also highlighted camizestrant's ability to reduce ESR1-mutant circulating tumor DNA, indicating a strong efficacy in combatting endocrine-resistant tumors. Safety profiles from these studies indicate that camizestrant is generally well-tolerated, with manageable side effects such as fatigue, anemia, and mild visual disturbances. The favorable balance between efficacy and safety has supported the advancement of camizestrant into further phase III trials, like SERENA-4 and SERENA-6, which are exploring its use in combination with CDK4/6 inhibitors for broader clinical application. Currently, the drug is in Phase III stage of its development for the treatment of HER2-negative breast cancer.

• (Z)-endoxifen: Atossa Therapeutics, Inc.

(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies have demonstrated that the therapeutic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein. (Z)-endoxifen also appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with tamoxifen. Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions in the stomach convert a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase I studies and in a small Phase II study of women with breast cancer. Currently, the drug is in Phase II stage of its development for the treatment of ER-positive, HER2-negative breast cancer.

• AC699: Accutar Biotechnology Inc

AC699 is a potent and selective orally bioavailable, chimeric degrader of estrogen receptor (ER) α, and offers a potential new breast cancer treatment option based on a differentiated mechanism of action as compared to fulvestrant and novel SERDs with deeper ERα degradation as demonstrated in preclinical studies. AC699 is currently being evaluated in an ongoing Phase I clinical study as a single agent for the treatment of ER-positive / HER2-negative locally advanced or metastatic breast cancer. The primary objectives are to evaluate the safety and tolerability of AC699. Secondary and exploratory objectives include pharmacokinetics, preliminary efficacy and pharmacodynamic evaluation. The study uses a 3+3 dose-escalation design, with once-daily oral dosing of AC699 at 100, 200, 300, 400, and 600 mg.

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

ER positive, HER2 negative Breast Cancer: Therapeutic Assessment

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

• Major Players in ER positive, HER2 negative Breast Cancer
• There are approx. 20+ key companies which are developing the therapies for ER positive, HER2 negative Breast Cancer. The companies which have their ER positive, HER2 negative Breast Cancer drug candidates in the most advanced stage, i.e. phase III include, AstraZeneca.
• Phases

DelveInsight’s report covers around 25+ 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

ER positive, HER2 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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

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

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

ER positive, HER2 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 ER positive, HER2 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 ER positive, HER2 negative Breast Cancer drugs.

ER positive, HER2 negative Breast Cancer Report Insights

• ER positive, HER2 negative Breast Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

ER positive, HER2 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 ER positive, HER2 negative Breast Cancer drugs?
• How many ER positive, HER2 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 ER positive, HER2 negative Breast Cancer?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the ER positive, HER2 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 ER positive, HER2 negative Breast Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• AstraZeneca
• Atossa Therapeutics, Inc.
• Accutar Biotechnology Inc
• VelosBio Inc
• Merus N.V.
• Pfizer
• Olema Pharmaceuticals, Inc.
• Eli Lilly and Company
• Novartis Pharmaceuticals
• Hoffmann-La Roche
• Ellipses Pharma
• BeiGene

Key Products

• Camizestrant
• (Z)-endoxifen
• AC699
• Zilovertamab vedotin
• Zenocutuzumab
• PD0332991
• Palazestrant
• LY3484356
• Letrozole
• Ipatasertib
• EP0062
• BGB-290