The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.

Start Date11 Aug 2025

Sponsor / Collaborator

University of Rochester

NCT06086132

/ Not yet recruitingNot ApplicableIIT

Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry (ISACS CARDIONCO-PREDICT)

This study is being done in order to assess the cardiovascular events known as cardiovascular toxicity of chemotherapy agents and radiotherapy protocols in cancer subjects to identify risk prediction, prevention and treatment of cancer therapy-related cardiovascular toxicity and cancer therapy-related cardiac dysfunction

Start Date01 Apr 2025

Sponsor / Collaborator

Alma Mater Studiorum - Università di Bologna

[+1]

NCT06686394

/ Not yet recruitingPhase 1/2

HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:
* About the safety and how well people tolerate of patritumab deruxtecan
* How many people have the cancer respond (get smaller or go away) to treatment

Start Date26 Feb 2025

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

[+1]

100 Clinical Results associated with Trastuzumab

100 Translational Medicine associated with Trastuzumab

100 Patents (Medical) associated with Trastuzumab

13,762

Literatures (Medical) associated with Trastuzumab

31 Dec 2025·Human Vaccines & Immunotherapeutics

Discussion on the mechanism of HER2 resistance in esophagogastric junction and gastric cancer in the era of immunotherapy

Review

Author: Li, Weiling ; Zhao, Jun ; Fan, Wenxuan ; Gao, Yangjun ; Hu, Wenqing ; Su, Fei ; Zhang, Yan ; Zhang, Xiaoling ; Du, Yunyi

Human epidermal growth factor receptor 2 (HER2) is a critical biomarker and therapeutic target in gastric/gastroesophageal junction (G/GEJ) cancers, despite the initial success of HER2-targeted therapies, such as trastuzumab, resistance to these drugs has emerged as a major impediment to effective long-term treatment. This review examines the mechanisms of drug resistance in HER2-positive G/GEJ cancer, the primary mechanisms of resistance explored include alterations in the HER2 receptor itself, such as mutations and changes in expression levels, as well as downstream signaling pathways, and interactions with the tumor microenvironment (TME). Furthermore, the review discusses the Novel therapeutic approaches, including the use of antibody-drug conjugates (ADCs) and combination therapies are assessed for their potential to enhance outcomes. By integrating recent research findings and clinical trials, this review aims to provide oncologists and researchers with insights into developing more effective treatments for patients with drug-resistant HER2-positive G/GEJ cancer.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

HER-2 SMASH

Article

Author: Şahin İnan, Zeynep Deniz ; Karaca, Mustafa ; Altun, Ahmet ; Yulak, Fatih ; Lacın, Burak Batuhan ; Öztürk, Ayşegül ; Alandağ, Celal

PURPOSE:

Human epidermal growth factor-2 (HER-2) targeted drugs are used in only HER-2 overexpressed cancers. However, only a small portion of these cancer types are HER-2 overexpressed. In this study, we aimed to upregulate HER-2 receptors in MCF-7 breast cancer and HT-29 colon cancer cell cultures, which these cells are not HER-2 upregulated in natural status.

METHODS:

We used a 10-day non-cytotoxic lapatinib dose to upregulate HER-2 receptors. HER-2 levels of these cell lines were tested with ELISA and immunofluorescence tests before and after 10 days of lapatinib administration. After upregulation of HER-2, we administered trastuzumab, and T-DM1 to these cell lines to observe whether there is an increase in anticancer activity. We used a cell viability test to show the cytotoxicity of trastuzumab and T-DM1. Also, we used ELISA and immunofluorescence for HER-2 pathway proteins to understand the mechanism of increased anti-cancer activity.

RESULTS:

We showed that administration of lapatinib for 10 days leads to overexpression of HER-2 receptors on both MCF-7 and HT-29 cells. A significant increase in the cytotoxicity of trastuzumab or T-DM1 was observed after 10 days of lapatinib administration.

CONCLUSION:

We named this method the smash method, which is the volleyball term. In volleyball, the ball is raised while low and quickly hits the ground again, just like we do with the HER-2 receptor. The smash method can switch HER-2 negative or HER-2 low tumors into HER-2 overexpressed, iatrogenically. Thus, we can use her2-targeted therapies in all cancer patients instead of a small portion.

01 May 2025·TALANTA

Labeling of oligosaccharides and N-linked glycans by a rhodamine-based fluorescent tag for analysis by capillary electrophoresis with laser-induced fluorescence and mass spectrometry detection

Article

Author: Cmelik, Richard ; Guttman, Andras ; Smolkova, Denisa ; Lavicka, Jana ; Dusa, Filip

In this work, we present the synthesis and application of fluorescent rhodamine B hydrazide for the derivatization of simple oligosaccharides and complex glycans using a hydrazone formation chemistry approach. The labeling conditions and the experimental setup of CE/LIF were optimized by analyzing oligosaccharide standards. The CE/LIF separations were performed in polybrene-coated capillaries eliminating the need for the purification step after derivatization. The addition of methanol to the background electrolyte significantly increased the LIF detection sensitivity reaching the limits of detection in the attomole range. The resolution of carbohydrate samples was improved by using long (98 cm) capillaries and polymer additives (polybrene). The developed method was applied for CE/LIF and CE-MS analysis of N-linked glycans released from bovine ribonuclease B and the therapeutic monoclonal antibody of trastuzumab.

841

News (Medical) associated with Trastuzumab

12 Feb 2025

·www.globenewswire.com

Greenwich LifeSciences Provides Update on Open Label HLA Data from FLAMINGO-01

Feb. 10, 2025 -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the following update on FLAMINGO-01 open label HLA data. Analysis of the open label data from FLAMINGO-01 has commenced and has been conducted in a manner that maintains the study blind. A preliminary review of FLAMINGO-01 HLA data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types, shows that approximately 46% of all screened patients have at least one HLA-A*02 allele from either parent. The main purpose of the open label arm is to investigate the safety and efficacy of GLSI-100 vaccination in patients who do not have an HLA-A*02 allele. It is possible that the open label arm may be large enough to draw immune response and efficacy conclusions. As discussed below, the HLA type can be analyzed by race and ethnicity in those patients who self-reported such information. CEO Snehal Patel commented, "The review of open label data and the ability to look at multiple patient populations in the Phase III trial will be much greater than was possible in the Phase IIb trial. The HLA-A*02 prevalence of 46% in all screened patients meets our expectations of 40-50% prevalence and supports our sample size estimates for the trial and the interim analysis. We are also interested in studying the 8% of patients who have received HLA-A*02 alleles from both parents, as the mechanism of action in these double HLA-A*02 patients could lead to greater immune response and efficacy." Mr. Patel further added, "There may be other subgroups of HLA types that can be analyzed in addition to the main arms. Approximately 92% of the patients that are in the HLA-A*02 arms have a second HLA-A type from the other parent that is not HLA-A*02 and could be any of 6 or more other prevalent HLA-A types. We can compare these HLA combinations against each other for immune response and clinical outcome, which could allow for subgroup analysis of HLA-A combinations. The prevalence of various HLA-A types by race or ethnicity may also help to inform the Company in its initial commercial development strategy by suggesting those markets where the most efficacious HLA patient populations may reside." Background on FLAMINGO-01 Trial Design and HLA Testing The design of the Phase III trial can be seen here. The trial is a prospective, randomized, double-blinded, multi-center study. The patient population is defined by major screening criteria and is stratified to balance the patient population between the treated and placebo arms of the trial. As currently designed, approximately 500 patients with the HLA-A*02 allele will be randomized to receive GLSI-100 (GP2 and GM-CSF) or placebo control in the first two pivotal arms of the trial with a planned interim analysis. In addition, patients without the HLA-A*02 allele will be enrolled in the third open label arm where all patients will receive GLSI-100 and where all endpoints will be open label. This non-HLA-A*02 arm was recently expanded from 100 to 250 patients based on recommendation of the steering committee and review/approval by the FDA and EMA. HLA-A*02 blinded arms: A patient has 2 HLA-A genes, one from each parent, thus a single HLA-A*02 patient has received the HLA-A*02 allele from one parent. A double HLA-A*02 patient has received the HLA-A*02 allele from both parents. Both single and double HLA-A*02 patients are enrolled in the HLA-A*02 treated and placebo arms, which are blinded. Those patients who have a single HLA-A*02 allele will also have a second HLA-A gene of any other type. Double HLA-A*02 Potential Mechanism of Action: Theoretically, a double HLA-A*02 patient may have double the amount of HLA-A*02-GP2 complex presented to the immune system to create cancer killing T-cells during the GLSI-100 vaccinations, and as a cancer cell recurs, the HER2 positive recurring cancer cells may have double the amounts HLA-A*02-GP2 complex for the trained T-cells to target and kill. It may be interesting to investigate immune or clinical response differences between single and double HLA-A*02 patients. Open Label non-HLA-A*02 Third Arm: If a patient has no HLA-A*02 alleles, they will have 2 different or identical non-HLA-A*02 alleles. These non-HLA-A*02 patients are enrolled in the open label arm, where the immune or clinical response can be assessed as a group or by each HLA-A type, including double HLA-A types, providing the number of patients is sufficiently high to draw conclusions or trends. Additional Information: A central laboratory in the US is sequencing the DNA of patients to determine both HLA-A allele types. The technology is available to sequence the HLA-B and HLA-C alleles, in addition to the HLA-A allele, to further assess other HLA types that may associate with GP2 to create a positive therapeutic effect. GP2 prediction binding algorithms may suggest that some HLA-B or HLA-C alleles may associate similarly to or stronger than HLA-A*02. A variety of HLA types are predicted to associate with GP2 based on binding algorithms, and such binding can be tested in preclinical experiments. However, HLA-A*02 is the most common HLA type, thus it was studied first, and all patients in the Phase IIb trial had at least one HLA-A*02 allele. The HLA data collected did not identify if a patient was double HLA-A*02, nor were any other non-HLA-A*02 alleles identified. Estimates of HLA prevalence by race are available in literature. As there are many sources and population studies to reference, a general consensus is that HLA-A*02 is prevalent in about 40-50% of the Caucasian population, which is the majority of the population in the US and Europe where the study is being conducted. To assess the prevalence of various HLA-A alleles by race, we have been collecting race and ethnicity data on all patients screened. We have summarized the preliminary data available to date in a blinded manner and have observed the results below. It is important to note that this preliminary summary may not reflect results at the end of the study. Across all screened patients, HLA-A*02 prevalence is about 46%. The double HLA-A*02 prevalence, in patients who have received HLA-A*02 alleles from both parents, is about 8%. Because there are 2 HLA-A genes, one from each parent, the total of all prevalence percentages exceeds 100% and is less than 200% because of double HLA-A types. The HLA-A*03, HLA-A*24, and HLA-A*01 prevalences are about 20-25% for each allele. The HLA-A*11, HLA-A*68, HLA-A*29, and HLA-A*30 prevalences are about 9-12% for each allele. In those screened patients who self-report as White, at least single or double HLA-A*02 genes are prevalent in approximately 50% of the patients. The double HLA-A*02 alleles are prevalent in 10% of these patients screened. The next most prevalent HLA-A types in the White populations are HLA-A*01 (29%), HLA-A*03 (21%), HLA-A*24 (19%), HLA-A*68 (10%), HLA-A*29 (13%), and HLA-A*11 (9%). In those screened patients who self-report as Hispanic or Latino, at least single or double HLA-A*02 alleles are prevalent in approximately 50% of the patients. The double HLA-A*02 genes are prevalent in 7% of these patients screened. The next most prevalent HLA-A types in the Hispanic or Latino populations are HLA-A*01 (20%), HLA-A*24 (22%), HLA-A*68 (22%), HLA-A*30 (18%), HLA-A*29 (13%), and HLA-A*11 (13%). In those screened patients who self-report as Black or African-American, at least single or double HLA-A*02 alleles are prevalent in approximately 40% of the patients. The next most prevalent HLA-A types in the Black or African-American populations are HLA-A*68 (33%), HLA-A*03 (27%), HLA-A*30 (27%), HLA-A*24 (13%), HLA-A*29 (13%), and HLA-A*23 (13%). In those screened patients who self-report as Asian, at least single or double HLA-A*02 alleles are prevalent in approximately 17% of the patients. The other prevalent HLA-A types are HLA-A*24 (42%), HLA-A*33 (42%), HLA-A*11 (25%), and HLA-A*03 (25%). The above preliminary Flamingo-01 open label data on HLA-A alleles by race and ethnicity is similar to the data available in literature. If any of the non-HLA-A*02 alleles have a strong association to GP2, it may be interesting to study the immune response and efficacy of GLSI-100 in patients with one allele of that type and one allele that is HLA-A*02 in addition to in patients with the double HLA-A*02 alleles. FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyClinical Result

11 Feb 2025

·www.prnewswire.com

New Breast Cancer Therapy to Reduce Risk of Recurrence and Improve Disease-Free Survival Now Approved in Thailand

NERLYNX® (neratinib) has been approved as a single agent for the treatment of early-stage HER2+ breast cancer, and in combination with capecitabine for the treatment of advanced or metastatic HER2+ breast cancer[1] Approval coincides with the first appointment of field force employees, signifying the growth of Specialised Therapeutics in Thailand SINGAPORE, Feb. 11, 2025 /PRNewswire/ -- A NEW breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now approved for use in Thailand.[1,2,3] NERLYNX® (neratinib), an oral medication, has been approved by the Thailand Food and Drug Administration (Thailand FDA) as a single agent "for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago."[1] Additionally, NERLYNX has been approved in combination with capecitabine"for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting."[1] In early breast cancer, NERLYNX has been shown to significantly reduce the ongoing risk of recurrence in women positive for human epidermal growth factor receptor 2 (HER2+), with the greatest benefit seen in women who are also hormone-receptor positive (HR+) and who commence therapy within 12 months of completing trastuzumab-based therapy.[2,3] For these women, the five-year risk of recurrence is reduced by up to 42%.[4] In women with advanced or metastatic HER2+ breast cancer, NERLYNX in combination with capecitabine (N+C) was found to significantly improve mean progression free survival (PFS) by 2.2 months over treatment with lapatinib plus capecitabine (L+C).[5] The duration of treatment response was longer for patients administered N+C (8.5 months) versus L+C (5.6 months), while the risk of disease progression or death was reduced by up to 24% among those treated with N+C at a median follow-up of 30 months.[5,6] NERLYNX is being made available in Thailand by independent pharmaceutical company, Specialised Therapeutics (ST), under exclusive license from Puma Biotechnology, Inc. ST Chief Executive Officer, Mr Carlo Montagner, said the approval of NERLYNX in Thailand was an important milestone for the company. "We are proud to have obtained approval of NERLYNX in Thailand for adults with HER2 positive breast cancer. This is a significant milestone for Specialised Therapeutics, but importantly also for women diagnosed with breast cancer in Thailand who will be presented with an opportunity to access a treatment that will help reduce the risk of disease recurrence and improve outcomes, in either the early or advanced stages of their disease." Breast cancer is the most common cancer diagnosed in Thai women, and the second leading cause of cancer mortality in females, behind liver cancer.[7] The incidence of breast cancer in Thailand has been rising at an alarming rate, with the annual age-standardised incidence rate doubling over the past 20 years (from 17.8/100,000 in 1998, to 35.7/100,000 in 2020).[8,9] In 2022, 21,628 Thai women were newly diagnosed with breast cancer, accounting for almost a quarter (23.2%) of all new cancer diagnoses in females.[7] Coinciding with the NERLYNX approval, ST is also pleased to announce the growth of its Thailand office, with new field force members due to join the company in March 2025. "We are extremely excited about the new journey we are undertaking in Thailand," said Mr Montagner. "Hiring our first field force employees, who have an extensive understanding of the local healthcare landscape, enables us to connect with oncologists around the country at the earliest opportunity, ahead of launching NERLYNX and making it available for eligible breast cancer patients as soon as possible. "As we continue to seek approvals for our strong pipeline of specialised medicines and technologies, we remain committed to meeting the needs of patients with rare diseases across Thailand, and making a difference to their lives. We look forward to working with the Thailand FDA and local specialists as we endeavour to provide timely access to these new treatments for the patients that need them." Ends. About NERLYNX NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.[10] It is an oral tablet and works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.[11,12] NERLYNX has received approval for the treatment of certain patients with extended adjuvant and/or metastatic HER2-positive breast cancer in more than 40 countries outside the United States (US), including the European Union (EU), China, Latin America, Australia, Canada, and Hong Kong. About HER2-Positive (HER2+) Breast Cancer Approximately 20-25% of breast cancer tumours over-express the HER2 protein. HER2-positive (HER2+) breast cancer is a highly heterogeneous tumour that is often more aggressive than other types of breast cancer and has a poor prognosis, increasing the risk of disease progression and death.[10,13,14] While trastuzumab has helped to improve the survival and prognosis of patients with HER2+ breast cancer, around 20-30% of patients will experience recurrence and metastases after trastuzumab targeted therapy.[14] About the ExteNET Study[2-4,15] The ExteNET trial was a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in patients with early-stage HER2-positive breast cancer. The ExteNET trial randomised 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomised to receive neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years after randomisation. The primary endpoint of the trial was invasive disease-free survival (iDFS). The trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p = 0.008). The 5-year iDFS rate for the neratinib arm was 90.2%, versus 87.7% for the placebo arm. An additional five-year sub-group analysis demonstrated a 42% reduction in risk of recurrence and 59% reduction in risk of CNS recurrence or death of any cause in women who were HR+ and who had commenced neratinib therapy within 12 months of completing treatment with trastuzumab. The most common adverse reactions (≥ 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection. About the NALA Study[5,6] The NALA trial was a randomised, active-controlled, Phase III trial investigating the efficacy of neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2+ metastatic breast cancer who had received two or more prior anti-HER2 based regimens in the metastatic setting. 621 patients were enrolled at 203 sites in 28 countries across Europe, North and South America, Asia, and Australia. The primary outcome measures for the trial were progression-free survival (PFS), and overall survival (OS). Median PFS was 5.6 months for patients who received N+C and 5.5 months for those receiving L+C (hazard ratio = 0.76, p = 0.0059). The PFS rate at 12 months was 29% versus 15%, respectively. Median OS was 21 months for patients receiving N+C, compared to 18.7 months for those receiving L+C (hazard ratio = 0.88, p = 0.2086). The most common adverse reactions of any grade (>5%) in the N+C arm were diarrhoea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, decreased weight, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. About Specialised Therapeutics Founded in 2007, Specialised Therapeutics is the region's largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. ST is a member of the World Orphan Drug Alliance (WODA). Additional information can be found at . References: SOURCE Specialised Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug ApprovalOrphan Drug

04 Feb 2025

·www.globenewswire.com

Greenwich LifeSciences Announces Activation of Flamingo-01 in Poland

Jan. 27, 2025 -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the activation of clinical sites in Poland. According to the latest data collected by the European Cancer Information System (click here), a total of 24,599 new cases of breast cancer were diagnosed in Poland in 2022, which is the most common cancer diagnosed in women, representing approximately 25% of all cancers in women. Breast cancer is the second leading cause of death from cancer in women in Poland with 8,723 deaths in 2022. The Company is collaborating with Dr. Piotr Wysocki, who is leading one of the largest academic and private breast cancer research networks in Poland, where 9 to 11 sites have agreed to participate in FLAMINGO-01. These sites were approved by Polish authorities, which has led to site initiation visits and the treatment of the first patient in Poland in 2024. Dr. Wysocki is Professor of Medicine and Head of Department of Oncology at Jagiellonian University Hospital in Krakow Poland. He has research interests in the development of novel apheresis-based cancer therapies, clinical application of metronomic chemotherapy, metronomic chemo-endocrine and chemo-targeted therapies for the treatment of breast, prostate, and ovarian cancers. CEO Snehal Patel commented, "Poland has a reputation for large treatment centers with high enrollment and standard of care. We look forward to working with Dr. Wysocki who is serving as the national principal investigator for Poland in FLAMINGO-01. We have been impressed with the sites that we have visited to date. In addition, we may have an opportunity to offer our study to Ukrainians who may have been displaced and now reside in Poland." FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS. The content above comes from the network. if any infringement, please contact us to modify.

Immunotherapy

100 Deals associated with Trastuzumab

External Link

KEGG	Wiki	ATC	Drug Bank
D03257	Trastuzumab	L01XC03	DB00072

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	JP	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
HER2 positive salivary gland cancer	JP	Chugai Pharmaceutical Co., Ltd.	25 Nov 2021
HER2-positive gastric cancer	JP	Chugai Pharmaceutical Co., Ltd.	10 Mar 2011
Stomach Cancer	US	Genentech, Inc.	20 Oct 2010
Breast Cancer	JP	Chugai Pharmaceutical Co., Ltd.	04 Apr 2001
Early Stage Breast Carcinoma	EU	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	IS	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	LI	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	NO	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	EU	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	IS	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	LI	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	NO	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	EU	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	IS	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	LI	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	NO	Roche Registration GmbH	28 Aug 2000
Metastatic Gastric Carcinoma	EU	Roche Registration GmbH	28 Aug 2000
Metastatic Gastric Carcinoma	IS	Roche Registration GmbH	28 Aug 2000
Metastatic Gastric Carcinoma	LI	Roche Registration GmbH	28 Aug 2000

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Colorectal Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Gallbladder Neoplasms	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Hematologic Neoplasms	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Lung Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Ovarian Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Pancreatic Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Prostatic Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Salivary Gland Neoplasms	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Skin Neoplasms	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02205047 (INNOVATION, ASCO_GI2025) Manual	Phase 2	HER2-positive gastric cancer HER2 Positive	172	Chemotherapy alone	qdoctlzsxt(qpcwguikko) = gxguxugrci vqjlhqecik (zltlmqjhhh ) View more	Negative	23 Jan 2025
				Chemotherapy + Trastuzumab	qdoctlzsxt(qpcwguikko) = gbutgqnigw vqjlhqecik (zltlmqjhhh ) View more
NCT05002127 (ASPEN-06, ASCO_GI2025) Manual	Phase 2/3	HER2 Positive Gastroesophageal Adenocarcinoma \| HER2-positive gastric cancer HER2+	127	EvorpaceptEvorpacept (ALX148) + Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	keeqbivafv(lwsddpwykf) = asuufapkzs cxsqsdmnji (qlhbosuwxh ) View more	Positive	23 Jan 2025
				Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	keeqbivafv(lwsddpwykf) = uqtkxsdiij cxsqsdmnji (qlhbosuwxh ) View more
NCT04579380 (SGNTUC-019, Pubmed \| Nat Med) Manual	Phase 2	Metastatic breast cancer HER2 Positive	31	Tucatinib + Trastuzumab	iriemqcqws(xxacjndame) = gjmnkgqiso dqhvvhrclw (yeezgrsxel, 26.9 - 58.2) View more	Positive	17 Jan 2025
NCT03365882 (S1613, Pubmed) Manual	Phase 2	RAS/BRAF Wild Type HER2 Positive Colorectal Cancer Second line \| Third line HER2 Positive	54	Trastuzumab plus Pertuzumab	vdsaconjrh(fygeirlwfo) = sovfmiywcv qddrdqokmw (tqrivohvye, 1.9 - 7.6) View more	Positive	06 Jan 2025
				Cetuximab plus Irinotecan	vdsaconjrh(fygeirlwfo) = isiehlkipe qddrdqokmw (tqrivohvye, 1.6 - 6.7) View more
NCT01897441 (CTgov)	Not Applicable	Metastatic breast cancer \| Breast Cancer 3 \| Advanced breast cancer	31	Cytology Specimen Collection Procedure+Trastuzumab+cyclophosphamide+Doxorubicin Hydrochloride+Paclitaxel (Stratum A: HER2-positive)	wcaktcwqay(pwftofwsmr) = guegcbmjep nqutgrvdwg (zyvueqviln, ekiuqffuzq - rnghqngdvq) View more	-	24 Dec 2024
				Cytology Specimen Collection Procedure+cyclophosphamide+Doxorubicin Hydrochloride+Paclitaxel (Stratum B: HER2-negative)	wcaktcwqay(pwftofwsmr) = hvgaxfifhf nqutgrvdwg (zyvueqviln, ihecdpejkl - nlaqbkvubb) View more
ESMO_IO2024 Manual	Phase 2	Advanced gastric carcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma First line	19	Cadonilimab+SOX (HER2-negative)	ghyoxywigq(bpfvclqiih) = hjjycmtmje nuvcxnxjdm (worzfplmwe ) View more	Positive	12 Dec 2024
				Cadonilimab+Trastuzumab+SOX (HER2-positive)	ghyoxywigq(bpfvclqiih) = cujapuglze nuvcxnxjdm (worzfplmwe ) View more
NCT05659056 (SABCS2024) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	52	pyrotinib + trastuzumab + nab-paclitaxel	snsscjpiyb(grrjigtndy) = kpwmccgrni outtqzlyeg (qndkvjijyt, 29.0 - 56.7) View more	Positive	10 Dec 2024
				pyrotinib + trastuzumab + nab-paclitaxel (HER2-enriched subtype)	snsscjpiyb(grrjigtndy) = vremghjkjg outtqzlyeg (qndkvjijyt, 37.9 - 73.2)
NCT05275010 (CTgov)	Phase 1	-	151	Handheld Syringe+Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (Arm 1: PH FDC SC Using a Handheld Syringe)	lehesacygt(jmxbgaiczn) = gxpytfzwil dcrkbcfjkv (ujfqhtxakn, izekuqtkxo - dhcgajljnq) View more	-	23 Sep 2024
				On-Body Delivery System (Arm 2: PH FDC SC Using the OBDS)	lehesacygt(jmxbgaiczn) = dpjookahnu dcrkbcfjkv (ujfqhtxakn, hbojkbllni - lgwfnxdzni) View more
ACTRN12620000767909 (ESMO2024) Manual	Phase 2	HER2 Positive Cancer ERBB2 Amplification \| ERBB2 Mutation (Activating)	31	Tucatinib trastuzumabumab	crjccxhigm(jygfavhdcj) = ehdzsadgbx ejigikpppq (dwsclybprw ) View more	Positive	14 Sep 2024
				Tucatinibtrastuzumab	crjccxhigm(jygfavhdcj) = pnfurzkyjb ejigikpppq (dwsclybprw ) View more
ESMO2024	Not Applicable	Breast Cancer	77	Trastuzumab	wgmckdtwdm(vwwbnsnnja) = ogyzntieeh kjmtnxjwkv (cmvakdgslc )	Positive	14 Sep 2024

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