Metastatic breast cancer (MBC) is an advanced stage of breast cancer where the disease spreads beyond the breast to other organs, most commonly the bones, liver, lungs, or brain. According to the World Health Organization, in 2022, approximately 2.3 million women were diagnosed with breast cancer globally, resulting in 670,000 deaths. Current therapies for MBC include targeted therapies, hormone therapies, chemotherapy, and immunotherapy. There is a growing focus on precision medicine and novel agents to improve patient outcomes. According to the metastatic breast cancer pipeline analysis by Expert Market Research, the treatment landscape is expanding rapidly, driven by increasing prevalence, advanced research, and rising demand for effective treatments, indicating strong growth in the coming years.
Major companies involved in the metastatic breast cancer pipeline analysis include Kelun-Biotech Biopharmaceutical Co., Ltd., DualityBio Inc., and others.
Leading drugs currently in the pipeline include SKB264, ARX788, BL-B01D1, and others.
The metastatic breast cancer drug pipeline is expanding with innovative targeted therapies, including HER2 and CDK4/6 inhibitors, and immunotherapies, driving significant clinical advancements and increased market opportunities in the coming years.
The Metastatic Breast Cancer Pipeline Analysis Report by Expert Market Research gives comprehensive insights into metastatic breast cancer therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for metastatic breast cancer. The metastatic breast cancer report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The metastatic breast cancer pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with metastatic breast cancer treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to metastatic breast cancer.
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Metastatic breast cancer is an advanced form of breast cancer in which malignant cells spread beyond the breast and nearby lymph nodes to distant organs such as bones, liver, lungs, or brain. It typically occurs when early-stage cancer cells evade treatment and migrate through the bloodstream or lymphatic system, leading to tumor growth in secondary sites and progressive disease.
Metastatic breast cancer treatments include targeted therapy, hormone therapy, chemotherapy, immunotherapy, and combination regimens, aimed at controlling tumor growth, alleviating symptoms, and prolonging patient survival while maintaining quality of life. Capivasertib with fulvestrant emerged as a notable pipeline advancement. In November 2023, the FDA approved this combination for adult patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer harboring PIK3CA/AKT1/PTEN-alterations, offering a new targeted therapy option following progression on prior endocrine therapy.
According to the World Health Organization, in 2022, an estimated 2.3 million women were diagnosed with breast cancer globally, resulting in 670,000 deaths. As per WHO, incidence and mortality vary with Human Development Index levels, with higher diagnosis in very high HDI countries but higher mortality in low HDI regions. According to BreastCancer.org, in the United States, breast cancer represents 32% of new female cancers, with 66% diagnosed at a localized stage. Given the rising incidence and persistent mortality, ongoing research and the development of novel therapies remain critical to improve survival outcomes and address unmet needs in metastatic breast cancer management globally.
This section of the report covers the analysis of metastatic breast cancer drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
By Drug Class
The metastatic breast cancer pipeline analysis report covers 50+ drug analyses based on drug classes:
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration.
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II (with 42%) covers a major share of the total metastatic breast cancer clinical trials. It is followed by phase I at 30%, and phase III at 14%. This distribution underscores a robust pipeline, with phase II trials driving innovation and potential treatment advancements. The presence of phase IV trials indicates a commitment to long-term treatment optimization and monitoring. Overall, this pipeline progression is poised to significantly impact the metastatic breast cancer market by introducing effective therapies that enhance patient outcomes and survival rates.
The drug molecule categories covered under the metastatic breast cancer pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, proteins. The metastatic breast cancer report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for metastatic breast cancer. Targeted small-molecule therapies are emerging as potential treatments for metastatic breast cancer. For instance, RK-33, a DDX3 protein inhibitor, is under investigation for breast cancer with bone metastases. Preclinical studies have shown that RK-33 can eliminate existing bone metastases and prevent further cancer spread. This drug demonstrates the ability to penetrate the bone microenvironment, offering a novel approach for patients with limited treatment options.
The EMR report for the metastatic breast cancer pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed metastatic breast cancer therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in metastatic breast cancer clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for metastatic breast cancer. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of metastatic breast cancer drug candidates.
SKB264 is a novel anti-TROP2 antibody-drug conjugate (ADC) being developed by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. It is in a Phase 3 study that is evaluating the efficacy and safety of SKB264 versus the investigator’s choice of chemotherapy in patients with unresectable, locally advanced, relapsed, or metastatic HR+/HER2- breast cancer who have previously failed endocrine therapy. SKB264 uses a sulfonyl pyrimidine-CL2A-carbonate linker to deliver a belotecan-derivative topoisomerase I inhibitor, targeting TROP2-overexpressing cancer cells to improve outcomes in this difficult-to-treat population.
ARX788 is an innovative HER2-targeted antibody-drug conjugate, linking a monoclonal antibody to the cytotoxic payload AS269 using proprietary site-specific technology. Sponsored by Ambrx, Inc., it is in a Phase 2 study, that is examining its safety and efficacy in HER2-positive metastatic breast cancer patients previously treated with T-DXd. The study is administering ARX788 via intravenous infusion every three weeks and is continuously monitoring tumor response, progression, and tolerability in a global, single arm setting.
BL-B01D1, sponsored by Sichuan Baili Pharmaceutical Co., Ltd., is undergoing a Phase I clinical study in patients with unresectable locally advanced or metastatic breast cancer and other solid tumors. This study is examining the safety, tolerability, dose-limiting toxicity, maximum tolerated dose, and recommended Phase II dose of BL-B01D1. The drug, a novel EGFRxHER3 bispecific antibody conjugated to a topoisomerase I inhibitor, is being evaluated for preliminary efficacy, pharmacokinetics, immunogenicity, and biomarker correlations.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Metastatic Breast Cancer Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for metastatic breast cancer. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into metastatic breast cancer collaborations, regulatory environments, and potential growth opportunities.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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