THE FASTER WE MOVE

MEDSIR is heading to SABCS 2021!

The San Antonio Breast Cancer Symposium (SABCS) is a leading event in the field of breast cancer, with the mission to provide a yearly update on the state-of-the-art information on breast cancer research.


After almost two years of the pandemic and virtual events, SABCS 2021 will have a hybrid format admitting both onsite and virtual participations. The symposium will take place from 7-10 of December, and the MEDSIR team will be onsite in San Antonio. Our collaborating physicians will be presenting 5 MEDSIR-sponsored trials, including results from the studies DEBBRAH, DxCARTES and LINGain and the design of the ongoing trials ABIGAIL and PHERGain-2.

DEBBRAH is an international, single-arm, open label, phase II, trial evaluating the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) in 5 cohorts of pre-treated patients with Human Epidermal Growth Factor Receptor 2-Positive (HER2[+]) or HER2-low Advanced Breast Cancer (ABC), presenting brain metastases (https://www.sabcs.org/BM) and/or leptomeningeal carcinomatosis (LMC). Dr. Marta Vaz-Batista, medical oncologist at Fernando Fonseca Hospital, Portugal, will present preliminary efficacy and safety data from cohort 1 and cohort 3. DEBBRAH has the potential to introduce a valid therapeutic option for all those BM and LMC patients who need more effective treatments. Due to its relevance, DEBBRAH has been selected for an oral presentation in the spotlight session Brain Metastases: Managing LMD / Targeting HER2 on December 8.


Abstract #2231: “Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive or HER2-low-expressing advanced breast cancer and central nervous system involvement: Preliminary results from the DEBBRAH phase 2 study”.

When: December 8, 2021. 5.00 PM-6.30 PM CST (12.00 PM – 1.30 AM +1 CET)


DxCARTES is an multicentric, open-label, Simon’s two-stage, phase II clinical trial. The study explores the ability of palbociclib in combination with letrozole to induce global molecular down-staging in patients with hormone receptor positive (HR[+]) / HER2[-] early breast cancers (EBC), measured by the Oncotype DX 21-gene recurrence score (RS). Final results of DxCARTES trial, including molecular characteristics of patients, clinical efficacy and safety, will be presented on December 10 by Dr. Antonio Llombart-Cussac, head of the Medical Oncology Service at the Hospital Arnau de Vilanova, Spain, and main author of the communication.


Abstract #2771: Neoadjuvant letrozole plus palbociclib in patients with hormone receptor-positive/HER2-negative early breast cancer with baseline Ki67 ≥20% and an Oncotype DX Breast Recurrence Score® result ≥18: DxCARTES

When: December 10, 2021. 7.00 AM-8.30 AM CST (2.00 PM – 3.30 PM CET)


LINGain is a prospective, case-control study aiming to investigate changes in the proportion, activation, and apoptosis of circulating αβ and γδ T cell subsets in a cohort of patients with HER2[+] EBC from PHERGain trial. In LINGain, blood samples of 24 patients from the cohort B of PHERGain, treated with a combination of trastuzumab and pertuzumab (anti-HER2 therapies) without the addition of chemotherapy, were compared to 48 normal healthy donors, seeking to identify immunological biomarkers of response linked to anti-HER2 therapies. Analysis of functional and apoptotic T cells, together with T cells subsets of differentiation, and association with clinical parameters will be presented by Dr. Llombart-Cussac, senior author of this communication, on December 10.


Abstract 2265: Analysis of αβ and γδ circulating T cells in the PHERGain randomized phase 2 trial for patients with HER2-positive early breast cancer receiving neoadjuvant trastuzumab and pertuzumab without chemotherapy: LINGain

When: December 10, 2021. 7.00 AM - 8.30 AM CST (2.00 PM – 3.30 PM CET)


ABIGAIL is one of MEDSIR’s newest designed and sponsored trial, and will be presented for the first time to the scientific community at SABCS 2021. This is an international, 2-arm, open label, phase II study of abemaciclib combined with ET (letrozole or fulvestrant) with or without a short course of induction chemotherapy with paclitaxel as first line therapy in patients with unresectable locally advanced or metastatic HR[+] / HER2[-] BC. The primary objective of this study will be to compare the efficacy of abemaciclib plus ET (arm A) versus paclitaxel (arm B). With ABIGAIL, we aim to provide consistent evidence that the combination of abemaciclib plus ET as first-line regimen is non-inferior to chemotherapy, mainly consisting of weekly paclitaxel. If this study reaches its primary objective, it could limit chemotherapy administration to aggressive luminal BC, avoiding all the chemotherapy-associated toxicities that might affect patients’ quality of life (QoL). Dr. Llombart-Cussac, main generator of this idea and PI of the study, will present ABIGAIL in the poster session “design of the ongoing trials” held on December 9.


Abstract #2280: Phase 2 study of abemaciclib in combination with endocrine therapy with or without paclitaxel induction in patients with hormone receptor-positive, HER2-negative advanced breast cancer and aggressive disease criteria: ABIGAIL.

When: December 9, 2021. 5.00 PM – 6.30 PM (12.00 PM – 1.30 AM +1 CET).


Last, but not least, we are glad to announce that we will present the design of our groundbreaking PHERGain-2 trial. Based on results from PHERGain, where a chemotherapy-sparing approach was explored in HER2[+] EBC, PHERGain-2 was designed as a response-adapted, multicenter, open-label, non-comparative, phase II study. This trial will further assess the feasibility of chemotherapy de-escalation with neoadjuvant trastuzumab and pertuzumab as unique treatment, followed by adjuvant treatment with either trastuzumab and pertuzumab or T-DM1 (another HER2-blocking therapy) using a pathological response-adapted strategy in low-risk HER2[+] EBC pts. If successful, this trial has the potential of positively impacting patients’ QoL, but at the same time preserving the best clinical efficacy for each patient towards a more personalized model of medicine. Dr. José Manuel Pérez-García, deputy director at International Breast Cancer Center (IBCC) in Barcelona, and first author of the communication, will be presenting the PHERGain-2 in the design of the ongoing trials session, held on December 8.


Abstract #1808: A phase 2 study of chemotherapy de-escalation using a pathological response-guided strategy in patients with HER2-positive, low-risk early breast cancer: PHERGain-2

When: December 8. 2021. 5.00 PM – 6.30 PM (12.00 PM – 1.30 AM +1 CET).


If you would like to know more about how MEDSIR helped oncology investigators turn their ideas into these fully funded independent clinical trials, or about any other MEDSIR-sponsored studies, do not hesitate to get in touch with us. Take advantage of SABCS to set up a face-to-face meeting with our MEDSIR team attending the symposium and bring your idea to life with us!

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