Usansolo, Bizkaia, Spain

HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan

This study will include patients with HR+/HER2- advanced/metastatic breast cancer who have progressed on prior endocrine therapy and CDK4/6i and who have received up to 1 prior regimen of chemotherapy or ADC for metastatic breast canncer. The primary objective is to evaluate the change in the CelTIL score, a combined biomarker based on stromal tumor-infiltrating lymphocytes and tumor cellularity, as surrogate of treatment response after one dose of sacituzumab govitecan (SG). Patients who fulfil all eligibility criteria will start SG at 10 mg/kg as an IV infusion on Days 1 and 8 of a 21-day cycle. SG will be administered continuously until progression of the disease, unacceptable toxicity, investigator's decision, withdrawal of consent, or other reasons described in the protocol. Tumor tissue (newly obtained) will be sent to a central laboratory. After 2 weeks(14-21 days) of treatment a new biopsy of the same lesion will be performed. Tumor biopsy will be also performed at disease progression / EoT. In addition, blood samples (for ctDNA) will be collected at C1D1, C2D1 and at progression / EoT for exploratory objectives. Imaging will be performed prior to day 1 of treatment and target and non-target lesions will be identified as per RECIST 1.1. Tumor assessments will be performed every 9 weeks until the start of a new anti-cancer therapy, withdrawal of consent, progression of disease, death, or the end of the study, whichever occurs first. Tumor assessments will be performed on the specified schedule regardless of treatment delays. Tumor response will be assessed as per RECIST v.1.1. Safety assessments will include the incidence, nature, and severity of AEs and laboratory abnormalities graded per the NCI CTCAE v.5.0. Laboratory safety assessments will include the regular monitoring of hematology, blood chemistry and pregnancy test.

Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC

(Neo)adjuvant chemotherapy in breast cancer is associated to long-term persistent QoL deterioration in patients with early breast cancer, with a greater negative impact in patients that were premenopausal at diagnosis. Because triple negative breast cancer (TNBC), which accounts for 10-20% of breast cancers, presents a poorer prognosis as compared to the other subtypes, international guidelines endorse the use of adjuvant chemotherapy from TNBC tumors measuring > 5 mm. Nevertheless, a number of retrospective studies have reported excellent prognosis for patients with small, lymph node-negative and high TILs TNBC, even without chemotherapy, with 5-year overall survival (OS) of 98%. Findings from multiple data sets consistently demonstrated that TILs represent a robust prognostic and predictive biomarker in early-stage TNBC, being now the first biological prognostic marker for TNBC included in several international guidelines for early-stage disease, such as 2019 St Gallen consensus conference and European Society for Medical Oncology (ESMO) Guidelines for early-stage breast cancer. In clinical practice, oncologists have taken different approaches in patients with stage I TNBC. While some have de-escalated anthracyclines, other did not held back on the standard chemotherapy options with anthracyclines, taxanes, and cyclophosphamide. Based on unpublished data from the TNBC pooled analysis with sTILs on 2211 patients not treated by systematic therapy, performed at Gustave Roussy, the 5-year distant disease free-survival (DDFS) is 87%, 91%, and 93% for those with stage I and sTILs ≥ 30%, 50%, and 75%, respectively. Given these compelling findings from historical observations, it is reasonable to anticipate that the absolute benefit of chemotherapy would be modest among these patients as their tumors generally exhibit a favorable prognosis, resulting in reduced benefits with the use of adjuvant chemotherapy. ETNA is a phase II, multicenter, biomarker-driven study that is designed to characterize the clinical course of patients with stage I TNBC and sTILs ≥ 30%. ETNA includes patients with stage I and sTILs ≥ 30% TNBC in 2 cohorts: - Cohort 1 will include patients age > 40 years with 30% ≤ sTILs < 50% and those aged ≤ 40 years with 30% ≤ sTILs < 75%. Patients will receive 9 cycles of adjuvant pembrolizumab 200 mg every three weeks for 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles. - Cohort 2 will include patients aged > 40 years with sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75% who will undergo standard surveillance (no adjuvant systemic treatments).

Effect of Methylcobalamin and Cyanocobalamin Consumption on Vitamin B12 Nutritional Status

DESTINY Breast Respond HER2-low Europe

This non-interventional study will investigate the effectiveness withT-DXd, the demographic and clinical characteristics of the patients, treatment patterns, tolerability, management of adverse drug reactions (ADRs), and patient experience of T-DXd in patients with HER2-low unresectable and/or metastatic breast cancer. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No drug product will be administered as part of this study. Data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part of the study.

Prebiotic EffecT InfanTs

The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.

Effect of Hybrid Laser 10600+1540 nm on GSM

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery

ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient perioperative atrial fibrillation and additional stroke factors after noncardiac surgery. The primary objective is to assess the effects of NOACs versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer

Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).

This registry is a Post-Authorisation Safety Study called the Increlex® Global Registry which is intended primarily to monitor the safety of Increlex® therapy in children and adolescents with Severe Primary IGF-1 Deficiency and secondly to follow the effectiveness of this treatment. Patients who have already started Increlex® therapy before entering this registry may be included and data will be collected retrospectively. The countries participating in this registry are Austria, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom and the USA