
IMaging PAtients for Cancer Drug selecTion - Metastatic Breast Cancer
Metastatic Breast CancerCurrent patient work-up, including conventional imaging and pathological assessment of just one single biopsy, might be insufficient to identify metastatic breast cancer patients, who possibly benefit from first-line anti-hormonal or anti-HER2 therapy. As receptor conversion of the tumor is found quite frequently and molecular heterogeneity can occur within one patient, up-to-date whole body information is necessary to determine estrogen receptor (ER) and/or human epidermal growth factor receptor 2 (HER2) receptor status and subsequently guide therapy decision. With molecular imaging via PET this information can be obtained in a non-invasive, patient friendly way. Furthermore, to improve and individualize treatment and be able to identify (new) drug targets and biomarkers, sampling of venous blood, circulating tumor cells (CTC), as well as circulating tumor DNA, microRNA (miRNA) and molecular characterization of one metastasis at the beginning and, if feasible, of an additional biopsy during therapy, is necessary.

Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
Breast NeoplasmThis non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS). Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by MFDS, safety and efficacy information of new medication will be provided at minimum 1,000 participants administered in the setting of routine practice during the initial 9 years after the approval.

Pilot Study Assessing the Effect of Cyclin-dependent Kinase 4/6 Inhibitors on Body Composition in...
Breast CancerThe goal of this study is to evaluate changes in body composition among patients who are treated with cyclin-dependent kinase (CDK) 4/6 inhibitors (abemaciclib, ribociclib, or palbociclib).

Using Imaging Data and Genomic Data to Predict Metastasis of Breast Cancer After Treatment
Breast CancerBreast cancer is the second leading cause of death for women around the world. Notably, most breast cancer patients die from tumor metastases in the liver, lungs, bones, or brain, not the primary tumor itself. Currently, clinicians are generally successful in treating primary tumors using standard protocols that are based on tumor sub-type and staging, as well as by the presence or absence of prognostic biomarkers. However, it remains difficult to assess in advance the likelihood of metastasis or relapse in any given patient.Physicians can only rely on regular post-treatment screening to monitor any secondary onset. By the time metastasis is detected, the golden window for treatment adjustment has often already passed. This project proposes to develop an analytical tool for predicting the likelihood of metastasis in breast cancer patients post-treatment using imaging and genomic data. We will evaluate our prediction model using prospectively-collected patient data. This new prognostic tool will enable physicians to adjust and tailor therapeutic strategies to each patient in a timely manner. Overall, the tool will personalize patient care, and improve their survival chances and quality of life.

Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery
Breast Ductal Carcinoma In SituBreast Lobular Carcinoma In Situ11 moreThis randomized phase I trial studies the side effects and best dose of endoxifen hydrochloride in treating participants who are undergoing breast surgery. Endoxifen hydrochloride may treat or reduce the risk of breast cancer.

Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v87 moreThis phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing side effects, a necessary feature of agents under development for cancer prevention.

PREgnancy and FERtility Registry
Breast NeoplasmsPregnancy1 moreThe PREgnancy and FERtility (PREFER) study is a comprehensive program aiming to optimize care and improve knowledge around the topics of fertility preservation and pregnancy issues in young breast cancer patients. The program was initiated at the National Institute for Cancer Research, IRCCS AOU San Martino - IST in Genova (Liguria Region, Italy) and then it has been spread to other Italian Institutions under the umbrella of the Gruppo Italiano Mammella (GIM) study group. It is composed of two distinctive studies, one assessing fertility (i.e. PREFER-FERTILITY) and the other pregnancy (PREFER-PREGNANCY) issues. Hence, two different study protocols were developed under the umbrella of the PREFER registry. PREFER-FERTILITY aims to obtain and centralize data about the preferences and choices of young cancer patients on the fertility preservation strategies available in Italy. Furthermore, it aims to assess the outcomes of patients undergoing one or more strategies for fertility preservation in terms of success of the techniques (i.e. recovery of ovarian function, number of cryopreserved oocytes, post-treatment pregnancies) and safety (i.e. long-term survival outcomes). PREFER-PREGNANCY has two main objectives: 1) to obtain and centralize data on the management of breast cancer diagnosed during pregnancy, the obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments, and the long-term survival outcomes of these patients; 2) to obtain and centralize data on the clinical outcomes of breast cancer survivors that achieve a pregnancy after prior diagnosis and treatment of breast cancer.

Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer...
Breast Neoplasm FemaleEarly-stage Breast Cancer4 moreThis bi-directional, multicentre study aims to assess multiparametric MRI Radiomics-based prediction model for identifying metastasis lymph nodes and prognostic prediction in breast cancer.

Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
TN ER-/PR-/HER2- Breast CancerTriple Negative Breast Cancer2 moreThis is a feasibility study to gain preliminary information regarding whether breast imaging with or without a core needle biopsy after neoadjuvant chemotherapy (NAC) but before surgery can accurately predict complete pathologic response (pCR) in women with triple negative or HER2- positive breast cancer. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.

Functional MRI in Predicting Response to Chemotherapy
Breast Cancer Patients• Address the accuracy of functional MRI techniques to predict response to neoadjuvant chemotherapy given to local advanced breast cancer patients with correlation with pathology thus allowing early chemotherapy regimen modification to increase number of patients achieving pathological complete response or save patients from toxic effects of ineffective chemotherapy.