Clinical Research Directory

ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer

The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting. ASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows: * Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open. * Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.

Stereotactic Ablative Body Radiotherapy (SABR) With Maintenance of Systemic Therapy Versus Physicians' Choice of Systemic Therapy for Oligoprogressive ER-positive, Her-2 Negative Breast Cancer II

The goal of this clinical trial is to assess Stereotactic Ablative Radiotherapy (SABR) as a method to delay a change in systemic therapy in patients with oligoprogressive ER-positive, HER2-negative advanced breast cancer. The main question it aims to answer is to assess whether the addition of SABR to continuation of first line endocrine therapy and CDK 4/6 inhibitor (Arm A) to patients with oligoprogressive ER-positive, HER2-negative advanced breast cancer could have longer time to strategy failure (TSF) in comparison to physician choice of systemic treatment (Arm B) in patients who had progressed first line. The treatment strategy in Arm A is to maintain patients on current endocrine therapy and CDK 4/6 inhibitor, controlling localised progressing sites of disease with SABR. Treatment strategy in Arm B is to maintain disease control with physician's choice of systemic therapy alone.

Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+/HER2- Metastatic Breast Cancer (mBC) Patients,

Development and validation of an integrated testing strategy for simultaneous detection of ESR-1 and gBRCA mutations via liquid biopsy in HR+/HER2- metastatic breast cancer (mBC) patients, and the creation of a digital gene library to support an evidence-based diagnostic algorithm

Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Who Achieved Durable Response by Anti-HER2 Treatment (HER2 CR)

Anti-HER2 therapy, such as trastuzumab and pertuzumab, has significantly improved long-term survival in HER2-positive breast cancer. The updated data of the CLEOPATRA trial showed significant Kaplan-Meier curves, suggesting the potential for a cure. However, the efficacy of maintenance therapy in long-term responders remains unexplored. This study will assess MRD in unresectable HER2-positive breast cancer cases with long-term response using the Signatera™ ctDNA assay, which could contribute to future treatment strategy development.

Artificial Intelligence Model-Assisted Accurate Diagnosis of Early-Stage Breast Cancer

Retrospectively collect the clinical data, breast MRI images, breast ultrasound images and reports, laboratory indicators (such as CA199, CA153, CA125, CEA/AFP), pathological diagnosis results, HE staining images, and existing immunohistochemical results (including CD8A, KPT5, GFRA1, PFKP, ER/PR percentage, Her-2 expression, Ki-67 index, etc.) of patients pathologically confirmed with or excluded from breast cancer in our center between January 2019 and December 2024. For biopsy specimens from patients diagnosed with breast cancer and immunohistochemically confirmed as HR+/Her-2+ during the same period, additional immunohistochemical staining for CD8A, KPT5, GFRA1, and PFKP should be performed, with images and results collected. The collected basic clinical information, imaging data, pathological findings, and laboratory metrics of patients will serve as candidate inputs. Units of measurement will be standardized, and missing data will be imputed using the multiple imputation by chained equations algorithm. Data harmonization will employ the Box-Cox algorithm, while min-max scaling will be used for standardization. The adaptive synthetic sampling method with a balance ratio of 0.5 will address data imbalance. For the collected patient data, deep learning will be applied to screen features from the images, combined with clinical significance to identify malignant risk factors. A neural network classifier will be trained on the training set data, with independent variables including breast MRI/ultrasound images, CA199, CA153, CA125, AFP/CEA, etc., and dependent variables including breast cancer status and subtype. Pathological biopsy results will be set as the validation standard. Model tuning will be conducted on the validation set to construct a breast cancer prediction model. It should be noted that as a single-center study, the results have limited generalizability. The further optimization and evaluation plan for the model involves using breast disease screening data from external centers for validation and refinement, evaluating the model's practical impact on clinical decision-making, and continuously tracking and optimizing its performance.

Integrin αvβ6-targeted PET in Malignant Tumors

Malignant tumors are a significant health threat with high incidence and mortality rates, and molecular imaging is crucial for early diagnosis, staging, prognosis evaluation, and therapeutic efficacy assessment. 18F-FDG PET imaging is widely used, but has limitations. Integrin αvβ6 is a promising target for tumor-targeted imaging, as it is only expressed in cancerous or reconstructed epithelial cells. A new PET probe, 68Ga-Trivehexin, targeting integrin αvβ6 has been developed with better affinity and selectivity than previous probes. Clinical data supports its safety and metabolic stability, and future research will explore its diagnostic and staging value in different types of tumors, providing a new and precise evaluation method for malignant tumors.

Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device

Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up. The identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up

Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study

PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4/6i as first-line of therapy for HR+/HER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.