Metastatic Breast Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Metastatic Breast Cancer Pipeline Insight" report provides comprehensive insights about 100+ companies and 100+ pipeline drugs in Metastatic Breast Cancer pipeline landscape. It covers the Metastatic Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Metastatic Breast Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Explore our latest breakthroughs in Metastatic Breast Cancer Research. Learn more about our innovative pipeline today! @ Metastatic Breast Cancer Pipeline Outlook- https://www.delveinsight.com/sample-request/metastatic-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Key takeaways from the Metastatic Breast Cancer Pipeline Report
• In March 2025:- Phoenix Molecular Designs conducted a study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer.
• In March 2025:- Merck Sharp & Dohme LLC announced study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) unresectable metastatic breast cancer. There is no formal hypothesis testing in this study.
• In January 2025:- Oncolytics Biotech:- The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy [paclitaxel] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 negative(HER2-) breast cancer, which is either locally advanced or has metastasized (cancer that has spread in your body). The study will investigate if pelareorep in combination with paclitaxel and avelumab is more effective than paclitaxel alone, or pelareorep and paclitaxel. The safety of the combination treatments will also be evaluated.
• In January 2025:- Eli Lilly and Company:- The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.
• In January 2025:- Allarity Therapeutics:- The Phase 2 study is using 2x-121 DRP® biomarker in metastatic breast cancer patients to identify patients likely to respond to and benefit from treatment with 2X-121. 2X-121 is a small molecule targeted inhibitor of Poly ADP ribose polymerase (PARP), a key enzyme involved in DNA damage repair in cancer cells. The PARP inhibitor demonstrated clinical activity in a prior Phase 1 study in a number of solid tumors. 2X-121 has a novel dual-inhibitory action against both PARP 1/2 and Tankyrase 1/2. The molecule is also active in P-glycoprotein expressing cells, suggesting it may overcome some of the PARP inhibitor resistance.
• DelveInsight's Metastatic Breast Cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for Metastatic Breast Cancer treatment.
• The leading Metastatic Breast Cancer Companies working in the market include Roche, RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, GlycoMimetics Incorporated, Rhizen Pharmaceuticals SA, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd., Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Jiangsu Hengrui Medicine Co., Tyme, Inc., Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., and Taizhou Hanzhong biomedical co. Ltd, and others.
• Promising Metastatic Breast Cancer therapies in the various stages of development include Tucatinib, Capecitabine, Trastuzumab, Palifosfamide, Bavituximab, NK105, Paclitaxel, Navelbine, Herceptin, and others

Stay informed about the cutting-edge advancements in Metastatic Breast Cancer treatments. Download for updates and be a part of the revolution in care @ Metastatic Breast Cancer Clinical Trials Assessment- https://www.delveinsight.com/sample-request/metastatic-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Metastatic Breast Cancer Emerging Drugs Profile
• Giredestrant: Roche
Giredestrant is a next generation investigational Selective estrogen receptor degrader (SERD), designed to fully block ER signalling with robust receptor occupancy. Oestrogen encourages HR-positive breast cancer cells to grow by attaching to the ER. Giredestrant works by blocking this receptor to prevent the action of oestrogen, and in the process causes the receptor to be degraded. This investigational medicine has also shown efficacy regardless of ESR1 mutation status (mutations in the ESR1 gene are important mechanisms of resistance to hormone therapy).

• Disitamab Vedotin: RemeGen
Disitamab Vedotin (RC48) is a novel anti-HER2 antibody-drug conjugate (ADC) which is currently across various solid tumor types. It was the first domestically-developed ADC in China approved by the CDE for clinical development in China. ADCs are a therapeutic modality consisting of an antibody molecule linked to a highly cytotoxic agent, and is typically designed to specifically deliver chemotherapies to tumor cells.

• EndoTAG®-1 (SB05): SynCore Biotechnology
SB05 is an innovative composition of the established cytostatic drug paclitaxel combined with neutral and positive lipids. Due to the positively charged lipids, SB05 interacts with newly developing, negatively charged endothelial cells, which are especially required for the growth of tumor blood vessels. The SB05 paclitaxel component attacks the activated endothelial cells as they divide, thus targeting the blood supply to tumors without affecting the supply to not activated endothelial cells of healthy tissue. By doing this, SB05 is expected to prevent the formation of new tumor blood vessels and to inhibit tumor growth.

• Stenoparib (2X-121): Allarity Therapeutics
Stenoparib (2X-121) is a unique, small molecule dual targeted inhibitor of Poly ADP-Ribose Polymerases (PARP 1 and 2) and telomerase maintenance enzymes (Tankyrase 1 and 2). Allarity exclusively in-licensed it (globally) from Eisai. Given its novel mechanism of action and ability to cross the blood brain barrier (BBB), plus its associated DRP®, stenoparib is poised to yield improved efficacy, lower toxicity, and lower drug resistance compared the other late-stage or marketed PARP inhibitors.

Learn more about Metastatic Breast Cancer Drugs opportunities in our groundbreaking Metastatic Breast Cancer Research and development projects @ Metastatic Breast Cancer Unmet Needs- https://www.delveinsight.com/sample-request/metastatic-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Metastatic Breast Cancer Companies
Roche, RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, GlycoMimetics Incorporated, Rhizen Pharmaceuticals SA, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd., Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Jiangsu Hengrui Medicine Co., Tyme, Inc., Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., and Taizhou Hanzhong biomedical co. Ltd, and others.

Metastatic 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
• Parenteral
• Intravenous
• Subcutaneous
• Topical.
• Molecule Type

Metastatic Breast Cancer Products have been categorized under various Molecule types such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy
• Product Type

Discover the latest advancements in Metastatic Breast Cancer treatment by visiting our website. Stay informed about how we're transforming the future of disease @ Metastatic Breast Cancer Market Drivers and Barriers, and Future Perspectives- https://www.delveinsight.com/sample-request/metastatic-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Scope of the Metastatic Breast Cancer Pipeline Report
• Coverage- Global
• Metastatic Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Metastatic Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
• Metastatic Breast Cancer Companies- Roche, RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, GlycoMimetics Incorporated, Rhizen Pharmaceuticals SA, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd., Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Jiangsu Hengrui Medicine Co., Tyme, Inc., Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., and Taizhou Hanzhong biomedical co. Ltd, and others.
• Metastatic Breast Cancer Therapies- Tucatinib, Capecitabine, Trastuzumab, Palifosfamide, Bavituximab, NK105, Paclitaxel, Navelbine, Herceptin, and others.

For a detailed overview of our latest research findings and future plans, read the full details of Metastatic Breast Cancer Pipeline on our website @ Metastatic Breast Cancer Emerging Drugs and Companies- https://www.delveinsight.com/sample-request/metastatic-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Table of Content
1. Introduction
2. Executive Summary
3. Metastatic Breast Cancer: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Metastatic Breast Cancer - DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. Giredestrant: Roche
9. Drug profiles in the detailed report.....
10. Mid Stage Products (Phase II)
11. Stenoparib - Allarity Therapeutics
12. Drug profiles in the detailed report.....
13. Early Stage Products (Phase I/II)
14. ARV-471: Arvinas
15. Drug profiles in the detailed report.....
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report.....
19. Inactive Products
20. Metastatic Breast Cancer Key Companies
21. Metastatic Breast Cancer Key Products
22. Metastatic Breast Cancer- Unmet Needs
23. Metastatic Breast Cancer- Market Drivers and Barriers
24. Metastatic Breast Cancer- Future Perspectives and Conclusion
25. Metastatic Breast Cancer Analyst Views
26. Metastatic Breast Cancer Key Companies
27. Appendix

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