The San Antonio Breast Cancer Symposium (SABCS) 2024 conference held in San Antonio, Texas, from December 10th to 13th, offered an incredible opportunity to hear the latest cutting-edge insights in experimental biology, causes, prevention, diagnosis, and treatment of breast cancer and premalignant breast conditions. This renowned multidisciplinary event drew an audience of academic and private physicians and researchers. It was also a fantastic opportunity for MEDSIR to present five of our groundbreaking trials to the scientific community: DEMETHER, ADELA, TUXEDO-4, PHENOMENAL and PRIMED.
DEMETHER: A single-arm phase II trial to evaluate the efficacy and safety of subcutaneous pertuzumab and trastuzumab maintenance after induction treatment with trastuzumab deruxtecan for previously untreated HER2[+] advanced breast cancer
The DEMETHER is an international, multicenter, open-label, single arm phase II clinical trial (NCT06172127). The main purpose of this trial is to evaluate the efficacy of a 6-cycle induction phase with trastuzumab deruxtecan (T-DXd) treatment followed by a maintenance phase with pertuzumab and trastuzumab treatment in patients with HER2[+] unresectable locally recurrent or advanced breast cancer. This approach aims to reduce the need for conventional chemotherapy. If the results are positive, this approach could represent a less aggressive and safer alternative, helping patients live longer with fewer side effects.
Download the poster here to learn more about the DEMETHER clinical trial. We also encourage you to download the lay language summary.
ADELA: Elacestrant + Everolimus in Patients ER[+]/HER2[-], ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i
MEDSIR, along with The Menarini Group and Stemline Therapeutics, presented research on the pioneering phase III clinical trial ADELA, which investigates a new therapeutic option combining elacestrant, a next generation, oral selective estrogen receptor degrader, with everolimus, an mTORC1 inhibitor in patients with advanced ER[+]/HER2[-] breast cancer that harbors ESR1 mutations, and who have experienced progression after standard first-line treatment. This double-blind, placebo-controlled trial (NCT06382948) will be conducted in several countries, such as Spain, Italy, France, Austria, the Czech Republic, Greece, Germany, the United Kingdom and Brazil. The aim of the study is to analyze the efficacy of this new combination compared to a single treatment using only elacestrant with placebo. Its primary objective is progression-free survival. The study also investigates other key aspects such as overall survival, toxicity profile, and impact on quality of life.
The expected outcomes of this trial not only seek to provide a more effective and tolerable therapeutic alternative but also aim to pave the way for the regulatory approval of this drug combination, expanding its potential clinical application to a broader population of patients with limited therapeutic options and significant side effects.
Download the poster here to learn more about the ADELA clinical trial. We also encourage you to download the lay language summary.
TUXEDO-4 trial: Trastuzumab-deruxtecan in HER2-low metastatic breast cancer patients with newly diagnosed or progressing brain metastases
We were excited to share the trial in progress design of the TUXEDO-4 trial. This international, multicentric, single arm, phase II study (NCT06048718) is enrolling patients from 13 medical institutions across Austria and Spain. The primary objective of the study is to evaluate the safety and efficacy of T-DXd in HER2-low breast cancer with newly diagnosed or progressing brain metastases with or without untreated type II leptomeningeal disease.
Remarkably, the poster for the TUXEDO-4 study has been awarded by the Guiding Researchers and Advocates to Scientific Partnership (GRASP) association, affiliated with SABCS 2024. GRASP is an organization dedicated to fostering collaboration, education, and advocacy within the scientific community. This association is often seen as a vital link between the scientific world and societal progress, working to ensure that scientific advancements are accessible, ethical, and impactful for all.
Download the poster here to learn more about the TUXEDO-4 clinical trial. We also encourage you to download the lay language summary.
PHENOMENAL: Efficacy and safety of liposomal irinotecan in patients with HER2-negative breast cancer and brain metastases
PHENOMENAL is an international, prospective, open-label, multicenter, single arm, two-stage Simon Design phase II clinical trial (NCT03328884), with the primary objective of assessing the efficacy of liposomal irinotecan (nal-IRI) single agent in a cohort of HER2[-] metastatic breast cancer patients with central nervous system involvement. This study included 56 pts across 16 hospitals in Spain between July 2017 and April 2024. The main objective is to assess the effectiveness of nal-IRI by analyzing the percentage of patients who experienced a reduction in the size of their brain tumors (intracranial objective response rate) after receiving nal-IRI therapy. Other key measures included how well nal-IRI worked on tumors outside the brain (extracranial objective response rate), and its safety and tolerability, among others. The results of the study suggested a significant nal-IRI antitumor activity in this cohort of patients, achieving a clinical reduction in brain tumor size in approximately 20% of patients.
Download the poster here to learn more about the PHENOMENAL clinical trial. We also encourage you to download the lay language summary.
PRIMED: Efficacy analysis and updated safety from the phase 2 PRIMED study of prophylactic granulocyte-colony stimulating factor (G-CSF) and loperamide for patients with HER2-negative advanced breast cancer treated with sacituzumab govitecan
The PRIMED study is a multicenter, open-label, single-arm, multicohort, two-stage optimal Simon's design, phase II clinical trial (NCT05520723) that is designed to improve the tolerance of sacituzumab govitecan in patients with unresectable locally advanced or metastatic triple negative breast cancer refractory to at least one, and no more than two, prior standard of care chemotherapy regimens in this setting who are not amenable to resection with curative intent. The PRIMED study explored new strategies to prevent common side of sacituzumab govitecan, such as diarrhea and neutropenia, which often disrupt treatment. By using prophylactic drugs, including G-CSF and loperamide, the study achieved a significant reduction in the incidence of these adverse effects. Preliminary results also suggest that this strategy facilitated treatment continuity with fewer interruptions.
Download the poster here to learn more about the PRIMED clinical trial. We also encourage you to download the lay language summary.
The studies presented by MEDSIR at SABCS introduce significant advancements toward more personalized treatments that are less invasive and better at managing side effects, contributing to improved survival rates and quality of life for patients. Moreover, MEDSIR’s presence at SABCS 2024 further solidifies status as a global leader in oncology research, highlighting its commitment to innovation and the advancement of more effective cancer therapies.
We are extremely proud of the work done at SABCS 2024 and we would like to especially thank to Miguel Sampayo, Data Science Specialist at MEDSIR, and Dr. Rui Rui Zhang, Business Development Director at MEDSIR, for presenting two of the studies with the community.
Finally, we cannot wait to participate in the SABCS Congress again next year! Please contact us if you want more information about any of the trials we presented and make sure to download the posters!
WHAT'S NEXT ON MEDSIR’S AGENDA?
Finally, as a gold standard event in oncology, the Annual ASCO Meeting is one of the most highly anticipated oncology conferences of the year and we are thrilled to be participating next year with a team onsite! The meeting is a fantastic forum to discuss and debate the current standards of cancer care and work together to determine how to improve upon ongoing issues and controversies.
Comments