A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer

This phase II trial tests how well stereotactic body radiation therapy (SBRT) works in treating patients with estrogen receptor positive (ER +) breast cancer that has spread from where it first started to other places in the body (metastatic) and has limited disease progression (oligoprogression). Currently, the standard of care for breast cancer patients with oligoprogressive disease is to change systemic therapy when progression occurs. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses (fractions) given over several days. This type of radiation therapy helps spare normal tissue and has been shown to improve survival. SBRT may kill more tumor cells and allow patients with oligoprogressive ER + metastatic breast cancer to continue taking current systemic treatment.
This trial also tests how well ER targeted positron emission tomography (PET)/ computed tomography (CT) imaging, using FES, works in identifying progressive disease in patients with ER + metastatic breast cancer. FES, a radiolabeled substance, binds to estrogen receptors and gives off radiation that can be detected by a PET scan. The PET scan, an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, FES, forms an image that shows where tumor cells with estrogen receptors can be found in the body. CT images use x-rays to provide an exact outline of organs. FES PET/CT may improve identification of progressive disease in patients with ER + metastatic breast cancer.

Start Date11 Jun 2024

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT05659797 / RecruitingEarly Phase 1

Pilot Study Evaluating the Uptake of [18F]Fluoroestradiol (FES) BPET/DBT in Primary Breast Cancer to Measure the Localized Extent of Estrogen Receptor Positive Disease

Patients with newly diagnosed primary estrogen-receptor (ER) positive breast cancer, with at least one breast lesion that is 1.0 cm in diameter or greater, may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 20 evaluable subjects will participate in a single imaging cohort. Study subjects will undergo imaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) following intravenous injection of [18F]-Fluoroestradiol (FES). This is an observational study; FES-BPET/DBT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the FES-BPET/DBT results, treatment decisions are made by the treating physicians based upon standard clinical imaging.

Start Date02 Oct 2023

Sponsor / Collaborator

Abramson Cancer Center

NCT05916196 / RecruitingPhase 2

[18F]FLUOROESTRADIOL (FES) PET/CT IMAGING OF THE ESTROGEN RECEPTOR IN PATIENTS WITH METASTATIC OR RECURRENT UTERINE CANCER

Women with known or suspected recurrent or metastatic uterine cancer may be eligible for this study. Patients may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania.
[18F]fluoroestradiol (FES) PET/CT imaging will be used to evaluate estrogen receptor (ER) activity in areas of disease known by standard of care imaging (e.g. CT, MRI, Bone Scan, FDG PET/CT, ultrasound) or clinical exam. For patients starting a new line of therapy, imaging will occur prior to starting new therapy. For patients who completed an initial scan and are starting new therapy, some patients may also undergo a second FES PET/CT scan at the time of suspected progression of disease to compare for changes in FES uptake measures (prior to initiation of next line therapy). The selection of therapy will be made by a treating physician and will not be affected by participation in this imaging study. Results of the FES PET/CT scan may be shared with the treating physician or subject by request but will not be used to make clinical decisions about treatment.

Start Date01 Sep 2023

Sponsor / Collaborator

Abramson Cancer Center

100 Clinical Results associated with Fluoroestradiol F 18

100 Translational Medicine associated with Fluoroestradiol F 18

100 Patents (Medical) associated with Fluoroestradiol F 18

250

Literatures (Medical) associated with Fluoroestradiol F 18

01 Mar 2024·Water research

A novel iron sulfide phase with remarkable hydroxyl radical generation capability for contaminants degradation

Article

Author: Lei, Dashi ; Wang, Chunli ; Li, Wenjing ; Zhang, Zhihao ; Che, Guiquan ; Zhang, Jing ; Gou, Chunli ; Hao, Zhengping

The hydroxyl radical (·OH) stands as one of the most potent oxidizing agents, capable of engaging in non-selective and instantaneous reactions with contaminants in water. Herein, we present a novel iron sulfide phase (S-FeS) characterized by an unprecedented structure, accompanied by its remarkable hydroxyl radical generation capability and contaminant degradation efficiency surpassing that of the conventional metastable iron sulfide phase, namely, the Mackinawite (FeS). In comparison to FeS, S-FeS exhibits enhanced degradation kinetics and higher efficacy in the removal of methylene blue, ciprofloxacin, and trivalent arsenic. Utilizing density functional theory (DFT) calculations, we postulate the mechanism for the exceptional contaminant degradation performance of S-FeS to be attributed to the increased exposure of the highly reactive (110) crystal facets. This research uncovers a new metastable phase that expands the polymorphisms within the iron sulfide family and showcases its capability for driving the oxygen reduction reaction.

01 Apr 2024·PET clinics

Quarter-Century Transformation of Oncology

Review

Author: Ulaner, Gary A ; Vaz, Sofia Carrilho ; Groheux, David

PET radiotracers have become indispensable in the care of patients with breast cancer. ¹⁸F-fluorodeoxyglucose has become the preferred method of many oncologists for systemic staging of breast cancer at initial diagnosis, detecting recurrent disease, and for measuring treatment response after therapy. ¹⁸F-Sodium Fluoride is valuable for detection of osseous metastases. ¹⁸F-fluoroestradiol is now FDA-approved with multiple appropriate clinical uses. There are multiple PET radiotracers in clinical trials, which may add utility of PET imaging for patients with breast cancer in the future. This article will describe the advances during the last quarter century in PET for patients with breast cancer.

01 Dec 2023·The Science of the total environment

High-efficiency and low-carbon inactivation of UV resistant bacteria in reclaimed water by flow-through electrode system (FES)

Article

Author: Cao, Ke-Fan ; Ikuno, Nozomu ; Sun, Yi-Ge ; Wu, Yin-Hu ; Hu, Hong-Ying ; Wang, Hao-Bin ; Koji, Nakata ; Chen, Zhuo

With the increasingly serious shortage of water resources globally, it has been paid more attention on how to secure the biosafety of reclaimed water and other non-traditional water sources. However, the 3 most applied disinfection technics, which are chlorine, ultraviolet (UV), and ozone disinfection, all have their disadvantages of selecting undesired bacteria and low energy utilization efficiency. Electrode disinfection is a promising solution, but the current electrode disinfection process still needs to be optimized in terms of the use conditions of the configuration reactivation. In this paper, we built a flow electrode system (FES). To evaluate the disinfection techniques more precisely, we isolated ultraviolet-resistant bacteria (URB) bacteria from the water of the full-scale water plant and tested the disinfection performance of FES and UV. The inactivation rate, reactivation potential, and energy consumption were analyzed. FES could inactivate 99.99 % of the URB and cause irreversible damage to the residual bacteria. FES could make all bacteria strains apoptosis in the subsequent 24 h of storage after alternating pulse current (APC) treatment, 3 V, within 27.7 s. Besides, the energy consumption of FES is about 2 orders lower than that of UV disinfection under the same inactivation rate. In summary, APC-FES is an efficient and low-carbon alternative for future water disinfection, which could achieve the ideal disinfection effect of a high inactivation rate, no reactivation, and low energy consumption.

News (Medical) associated with Fluoroestradiol F 18

04 Jun 2024

·www.biospace.com

GE HealthCare Pharmaco-Economic Study Demonstrates Adding Breast Oncology PET Tracer to Standard Workup of Patients with Metastatic or Recurrent Breast Cancer May Yield Beneficial Clinical and Economic Outcomes, Potentially Saving $142M Over...

Adding a PET/CT scan with [18F]FES, a breast oncology PET tracer, may increase the accuracy of knowing the estrogen receptor (ER) status. This is notable when a tumor sample cannot be obtained, or the risk of a biopsy-related complication is high. Increased diagnostic accuracy may help clinicians select more effective treatments and decrease the rate of re-biopsies, resulting in the potential cost savings of $142M to the US healthcare system over a five-year period,1 according to a new study published in PLOS ONE. The study shows that adding a PET/CT scan with the [18F]FES tracer, commercially available in the US as Cerianna, to biopsy/immunohistochemistry (IHC) may increase the number of true positive and true negative ER status test results by up to eight percentage points2 compared to when biopsy/IHC is used alone. MARLBOROUGH, Mass.--(BUSINESS WIRE)-- GE HealthCare Pharmaco-Economic Study Demonstrates Adding Breast Oncology PET Tracer to Standard Workup of Patients with Metastatic or Recurrent Breast Cancer May Yield Beneficial Clinical and Economic Outcomes, Potentially Saving $142M Over Five Years in the US In a GE HealthCare sponsored pharmaco-economic study published in peer-reviewed journal PLOS ONE, the incidence, prevalence, diagnostic pathways, and treatments of different patients with metastatic or recurrent breast cancer were analyzed using a combination of widely accepted statistical modelling methods to estimate the clinical and associated economic impact of adding a PET/CT scan with [18F]FES, a breast oncology PET tracer, to the current standard diagnostic process. Breast cancer is the most diagnosed cancer worldwide, with approximately 2.3 million new cases appearing in 2020 alone.3 Correct identification of the receptor status in breast cancer is crucial to optimize treatment; however, the diagnostic standard of care which involves biopsy/IHC and imaging, can yield inconclusive results. [18F]FES can be a powerful tool, providing high diagnostic accuracy in detection of estrogen receptor (ER)-positive lesions. The study demonstrated that adding a PET/CT scan with [18F]FES to biopsy/IHC may increase the diagnostic accuracy of the ER status in all appropriate patients with metastatic or recurrent breast cancer. The clinical and economic benefits were especially pronounced in those situations where a tumor sample cannot be obtained, or the risk of a biopsy-related complication is high. Regina Young, Head of Global Market Access in the Pharmaceutical Diagnostics segment of GE HealthCare and lead author of the study said, “We found that if [18F]FES PET/CT was added to the standard diagnostic work up and in line with the Appropriate Use Criteria (AUC) for ER-targeted PET Imaging,4 the increase in diagnostic accuracy could improve the clinical outcomes. Additionally, results suggested a positive correlation between increased diagnostic accuracy, especially when multiple lesions are present,” said Young. "The increase in true ER-positive and ER-negative results may have beneficial clinical and economic outcomes primarily driven by the avoidance of repeated biopsies and futile treatments.” In 2023, FES PET imaging was added to the National Cancer Care Network (NCCN) Clinical Practice Guidelines in Oncology for ER-positive disease under certain circumstances during the systemic staging workup of patients with metastatic and recurrent breast cancer. This inclusion came after the Society of Nuclear Medicine and Molecular Imaging (SNMMI) published its AUC to guide referring and imaging physicians in appropriate use of ER-targeted PET imaging with 16α-18F-fluoro-17ß Fluoroestradiol. According to SNMMI, the inclusion of FES PET in its AUC is intended to help healthcare practitioners provide patients with the best care in a cost-effective manner. The AUC may also enable more efficient approval of FES use by payers.5 GE HealthCare’s Cerianna is the only FDA-approved FES PET imaging agent. Cerianna is indicated for use with PET imaging for the detection of ER-positive lesions as an adjunct to biopsy in patients with metastatic and recurrent breast cancer. Providing a whole-body view of ER-positive lesions, Cerianna may deliver a comprehensive assessment to assist in making an informed diagnosis and individualized treatment plan for the patient. GE HealthCare’s Pharmaceutical Diagnostics segment is a global leader in imaging agents used to support around 119 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology, and oncology, with an innovative pipeline, all aimed at enabling better-informed diagnosis and monitoring for improved therapy decision-making and clinical outcomes. About GE HealthCare Technologies Inc. GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits. Follow us on LinkedIn, X (formerly Twitter), Facebook, Instagram, and Insights for the latest news, or visit our website for more information. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. INDICATIONS AND USAGE: CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Limitations of Use: Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). Important Safety Information CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Risk of Misdiagnosis Inadequate Tumor Characterization and Other ER-Positive Pathology Breast cancer may be heterogeneous within patients and across time. CERIANNA images ER and is not useful for imaging other receptors such as HER2 and PR. The uptake of fluoroestradiol F 18 is not specific for breast cancer and may occur in a variety of ER-positive tumors that arise outside of the breast, including from the uterus and ovaries. Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer. False Negative CERIANNA Scan A negative CERIANNA scan does not rule out ER-positive breast cancer. Pathology or clinical characteristics that suggest a patient may benefit from systemic hormone therapy should take precedence over a discordant negative CERIANNA scan. Radiation Risks Diagnostic radiopharmaceuticals, including CERIANNA, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe drug handling and patient preparation procedures (including adequate hydration and voiding) to protect patients and health care providers from unintentional radiation exposure. Pregnancy Status Assessment of pregnancy status is recommended in females of reproductive potential before administering CERIANNA. ADVERSE REACTIONS In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary All radiopharmaceuticals, including CERIANNA, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of CERIANNA. There are no available data on CERIANNA use in pregnant women. No animal reproduction studies using fluoroestradiol F 18 have been conducted to evaluate its effect on female reproduction and embryo-fetal development. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Lactation Risk Summary There are no data on the presence of fluoroestradiol F 18 in human milk, or its effects on the breastfed infant or milk production. Lactation studies have not been conducted in animals. Advise a lactating woman to avoid breastfeeding for 4 hours after CERIANNA administration in order to minimize radiation exposure to a breastfed infant. Pediatric Use The safety and effectiveness of CERIANNA in pediatric patients have not been established. Geriatric Use Clinical studies of fluoroestradiol F 18 injection did not reveal any difference in pharmacokinetics or biodistribution in patients aged 65 and over. DRUG INTERACTIONS Systemic Endocrine Therapies that Bind to ER Drugs that bind to the ER, including SERMs and SERDs, may compete with the binding of fluoroestradiol F18 and may reduce detection of ER-positive lesions with CERIANNA. Before administration of CERIANNA, discontinue drugs that bind to the ER, such as SERMs and SERDs, for at least 5 biological half-lives: (e.g. elacestrant for 11 days, tamoxifen for 8 weeks and fulvestrant for 28 weeks). To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800 FDA 1088 or 1 Munter-Young R, Fuentes-Alburo A, DiGregorio N, Neeser K, Gultyaev D (2024) Clinical and economic outcomes of adding [18F]FES PET/CT in estrogen receptor status identification in metastatic and recurrent breast cancer in the US. PLoS ONE 19(5): e0302486. 2 Munter-Young, Fuentes-Alburo, DiGregorio, Neeser, Gultyaev, 2024, Table 3 3 Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209–49. Epub 20210204. pmid:33538338. 4 Ulaner G, Mankoff D, Clark AS, Fowler AM, Linden HM, Peterson LM, Dehdashti F, Kurland BF, Mortimer J, Mouabbi J, Hyuk Moon D, de Vries EGE (2023) Summary: Appropriate Use Criteria for Estrogen Receptor-Targeted PET Imaging with 16α-F-Fluoro-17β-Fluoroestradiol. The Journal of Nuclear Medicine 64 (3) 351-354. 5 Ulaner G, Mankoff D, Clark AS, Fowler AM, Linden HM, Peterson LM, Dehdashti F, Kurland BF, Mortimer J, Mouabbi J, Hyuk Moon D, de Vries EGE (2023) Summary: Appropriate Use Criteria for Estrogen Receptor-Targeted PET Imaging with 16α-F-Fluoro-17β-Fluoroestradiol. The Journal of Nuclear Medicine 64 (3) 351-354. View source version on businesswire.com: Contacts GE HealthCare Media Contact: Emmy Elguizaoui +1 (978) 243-7503 Emmy.Elguizaoui@gehealthcare.com Source: GE HealthCare View this news release online at:

Radiation Therapy

07 Feb 2024

·www.fiercebiotech.com

GE HealthCare plots theranostics growth as it beats earnings estimates in first solo year

“In the next three years, we plan to significantly increase our current theranostics franchise through a combination of organic and inorganic expansions,” GE HealthCare President and CEO Peter Arduini said on the company's fourth-quarter earnings call. In its first full 12 months as an independent, public company, GE HealthCare posted an 8% boost in organic annual revenue—but the company said it doesn’t expect that trajectory to continue into its sophomore year. The imaging giant has set its 2024 expectations at 4% organic sales growth. On a call with investors for the company’s fourth-quarter earnings report this week, Chief Financial Officer Jay Saccaro attributed last year’s gains to recovering supply chains and pricing advantages. “And a lot of that came down to execution, in terms of translating backlog into sales—which was a testament to the work by many of our teams. So, as we look to 2024, we think roughly 4% is a solid number,” said Saccaro, who also described 2023’s 8% figure as the high end of the company’s previous full-year predictions and “in excess of our expectations for the fourth quarter.” In terms of total revenue, GE HealthCare brought in $19.6 billion during 2023—including $10.6 billion from its CT and MRI imaging systems, $3.5 billion from ultrasound devices, $3.1 billion in patient care and monitoring solutions and $2.3 billion from pharmaceutical diagnostics. That last portfolio, with its nuclear medicine and cancer-targeting imaging tracers, grew 18% year-over-year and 23% in the fourth quarter, driven by global expansions in diagnostic procedures and their need for imaging agents. “As novel therapies become more widely available, our tracers will play an increasingly important role—putting us at the center of this transformation of care that will help enable better patient outcomes across many pathways as functional imaging expands,” President and CEO Peter Arduini said on the investor call. “We see growth opportunities with our existing products—like Vizamyl for patients with suspected Alzheimer’s disease, as new therapies ramp up—and Cerianna for metastatic breast cancer, which are both used in conjunction with PET systems for diagnosis,” Arduini added. “And Flurpiridaz, a pipeline product for diagnosing and assessing coronary artery disease, is expected to significantly advance PET/CT imaging.” These injectable imaging tools are also expected to help set the stage as patient care turns more toward theranostic procedures, blurring the lines between discrete tests and treatments. “To give you some perspective, currently the overall theranostics market—which includes equipment, tracers and therapies—is about $9 billion and expected to grow to $40 billion by 2032,” Arduini said. “Today, theranostics are primarily used in thyroid, neuroendocrine and prostate tumors. However, a growing pipeline of drugs across the industry that includes breast, ovarian, pancreatic and lung cancers shows even more promise.” “In the next three years, we plan to significantly increase our current theranostics franchise through a combination of organic and inorganic expansions,” he said, highlighting GE HealthCare’s recently proposed acquisition of the AI developer MIM Software and its plans to integrate the latter’s imaging analysis programs for radiation oncology, molecular radiotherapy, urology and theranostics in particular. GE HealthCare’s first year also saw the company pay down $1 billion in debt while putting more than $1 billion into its R&D spend and launching more than 40 new products. “As a result of our investments, we estimate that we have gained global market share in equipment in 2023. And, once again, we topped the FDA’s list of AI-enabled device authorizations with 58, more than any other medtech company,” Arduini said, referring to the agency’s accounting. “Our backlog remains robust, led by an improved capital equipment landscape.” For the fourth quarter of 2023, the company posted $5.2 billion in sales for a 5% gain over the same period the year before. Net income, however, dropped to $403 million from $554 million, while the accounting for the full year fell to $1.6 billion, compared to 2022’s $1.9 billion. All told, the price of GE HealthCare’s stock on the Nasdaq jumped more than 12% following its earnings release, to more than $81 per share. The company completed its split from the General Electric mothership in January 2023.

Acquisition

23 Oct 2023

·www.prnewswire.com

Luoxin Pharmaceutical's LX-039 (Innovative Anti-Tumor Drug): Phase I Clinical Study Data Presented at ESMO 2023

SHANGHAI, Oct. 23, 2023 /PRNewswire/ -- From October 20 to 24, the 2023 ESMO Congress was held in Madrid, Spain. LX-039, an innovative anti-tumor drug developed by Luoxin Pharmaceuticals Group Stock Co., Ltd. (Luoxin Pharmaceutical), was selected for poster presentation at the 2023 ESMO Annual Congress. ESMO is one of the most influential oncology conferences globally, attracting over 30,000 professionals every year from more than 150 countries and regions. The Congress covers basic research, translational research, and the latest advancements in clinical studies, providing an exchange platform in clinical diagnosis, treatment, and academic discussions. LX-039 is an innovative selective estrogen receptor degrader (SERD) for oral administration. The aims of the dose escalation and expansion phase I study was to explore the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) profiles of LX-039 in postmenopausal patients with ER+ and HER2- advanced breast cancer who have failed endocrine therapy. The study was led by Professor Hu Xichun from Fudan University Shanghai Cancer Center. In a 3+3 design, the trial evaluated the safety and tolerability from a daily dose of 50 mg to 1200 mg, with two dosage groups selected for expansion. [18F] Fluoroestradiol PET/CT imaging was used for PD study. All 44 enrolled subjects had previously undergone multiple lines of endocrine therapy. Specifically, 72.7% had received second-line therapy or higher. More than half had been treated with fulvestrant, a medication commonly used for hormone receptor-positive breast cancer. Also, over 50% had received advanced chemotherapy, and 40.9% had been treated with CDK4/6 inhibitors. Maximum tolerated dose (MTD) was not reached in this study. Most adverse events are graded as mild to moderate (grade 1-2). The exposure of LX-039 increased along with the dose escalation, and no obvious accumulation after multiple doses. Inhibition of the ER pathway is observed in all subjects participating in the PD exploration. Four subjects achieved partial response, with an objective response rate of 10.8% and a clinical benefit rate at 24 weeks of 40%. LX-039 demonstrates good tolerability and PK/PD properties in ER+ and HER2- advanced breast cancer and shows preliminary anti-tumor activity. These encouraging results suggest that LX-039 holds great potential for further development. Consequently, a phase II study is under planning. About 75% of breast cancer cases are classified as ER+. This subtype of breast cancer relies on the estrogen signaling pathway for its growth and progression. The primary therapeutic approach for ER+ breast cancer involves inhibiting the estrogen signaling pathway through various methods. Notably, drugs like tamoxifen and fulvestrant have been utilized in clinical settings to target the ER pathway. However, tamoxifen resistance and treatment non-compliance with fulvestrant have led to unmet clinical needs. LX-039, an orally administered selective ER degrader (SERD) developed by Louxin Pharmaceutical, specifically focuses on modulating the estrogen signaling pathway. It antagonizes ER actions and promotes its ubiquitination and degradation within breast cancer cells, downregulating ER expression. LX-039 offers unique therapeutic benefits compared to selective ER modulators and aromatase inhibitors. Additionally, its oral formulation enhances patient convenience and compliance, as it eliminates the need for injections. There are currently no domestically available oral drugs with a similar mechanism of action to LX-039 in the market. References: Wang Y, Ayres K L, Goldman D A, et al. 18F-fluoroestradiol PET/CT measurement of estrogen receptor suppression during a phase I trial of the novel estrogen receptor-targeted therapeutic GDC-0810: using an imaging biomarker to guide drug dosage in subsequent trials[J]. Clinical Cancer Research, 2017, 23(12): 3053-3060. Patel H K, Bihani T. Selective estrogen receptor modulators (SERMs) and selective estrogen receptor degraders (SERDs) in cancer treatment[J]. Pharmacology & therapeutics, 2018, 186: 1-24. About Luoxin Pharma Luoxin Pharmaceutical Group Stock Co., Ltd. ("Luoxin Pharma", stock code: 002793.SZ ) was founded in 1988. With the mission of "Source of health", Luoxin Pharma insists upon innovation of science and technology, focuses on the unmet medical needs in GI, respiratory and oncology, etc., and dedicates bringing more innovative medicine to patients around the world. Luoxin Pharma has a rich and competitive portfolio of products and the star products take the lead in GI and respiratory. Many products were listed in major science and technology projects, such as National Major New Product Plan, National Torch Plan as well as Major New Drug R&D. In addition, having been ranking among Top 100 Chinese Pharmaceutical Enterprises since 2006, and among Best Enterprises in Chinese Pharmaceutical R&D Pipelines since 2011, Luoxin Pharma was recognized as State Key High-tech Enterprise, State Technology Innovation Model Enterprise, National Industrial Quality Model Enterprise, and multiple scientific research achievements were awarded the 2nd prize for the State Sci. & Tech Progress. For more information, please visit . SOURCE Luoxin Pharmaceutical Group Stock Co., Ltd.

Phase 1Clinical ResultPhase 2ASCO

100 Deals associated with Fluoroestradiol F 18

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	V09IX11	DB15690

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic breast cancer	US	GE Healthcare, Inc.	20 May 2020
Breast Cancer	FR	Zionexa SAS	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Breast cancer recurrent	Phase 3	KR	Asan Medical Center	01 Nov 2013
Estrogen receptor positive breast cancer	Phase 2	US	University of Pennsylvania	01 May 2015
Hormone refractory breast cancer	Phase 2	US	University of Pennsylvania	01 May 2015
Endometriosis	Phase 2	FR	Centre Hospitalier Universitaire d'Angers	01 Jun 2012
Adenomatous Polyposis Coli	Phase 1	US	National Cancer Institute	01 Apr 2015
Aggressive Fibromatosis	Phase 1	US	National Cancer Institute	01 Apr 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04692103 (CTgov)	Phase 2	Breast cancer recurrent \| Metastatic breast cancer	2	Computed Tomography+Fludeoxyglucose F-18+F-18 16 Alpha-Fluoroestradiol	wkwfeapgtr(yukjcvhbvp) = vzyjzuoqhx qokrcxwyws (jdgcmljeuy, iooituxrju - sepwsigurv) View more	-	21 Feb 2023
NCT04382911 (CTgov)	Phase 2	Endometriosis	8	18F-fluoroestradiol	ewabuqcbvo(ivzpwmviqr) = tiylbjtxll yfdufgnfqg (gavcranwwa, wowsashbav - vsyydldjev) View more	-	09 Feb 2023
NCT01720602 (Pubmed \| J Nucl Med) Manual	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast ER positive \| HER2 negative	8	Vorinostat+18F-fluoroestradiol	vujizboaml(bfxavumeyz) = lxzzwrrxxz hxoyrcqfqb (pfemntzvnp )	Negative	01 Feb 2021

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