Clinical Research Directory

AKU Study - Acupuncture for Aromatase Inhibitor-Induced Musculoskeletal Syndrome

Third-generation aromatase inhibitors (AIs) represent a standard adjuvant endocrine treatment for postmenopausal and high-risk premenopausal women with hormone receptor-positive early breast cancer. However, aromatase inhibitor-associated musculoskeletal syndrome (AIMSS)-characterized by joint pain, stiffness, and reduced mobility-occurs in approximately 50% of patients and significantly impairs treatment adherence and patient quality of life. Poor adherence to endocrine therapy is associated with reduced overall survival. The purpose of this prospective, randomized (1:1), open-label, parallel-group clinical trial is to evaluate the efficacy, safety, and duration of therapeutic relief of acupuncture in managing AI-induced musculoskeletal symptoms in female patients with early-stage breast cance. A total of 200 participants experiencing AI-related joint pain are randomized either to receive 10 weekly 20-minute sessions of manual acupuncture over 10 weeks or to a control group receiving standard care without acupuncture. Joint pain severity, upper limb muscle strength and dexterity, sleep quality, and psychological distress are evaluated using validated patient-reported outcomes (Brief Pain Inventory \[BPI\], Rheumatoid Arthritis Pain Scale \[RAPS\], Pittsburgh Sleep Quality Index \[PSQI\], and Hospital Anxiety and Depression Scale \[HADS\]) as well as objective physical performance tests (Hand Grip Strength Test and Grip Ability Test) at baseline, 10 weeks, 14 weeks (4 weeks post-intervention), and 22 weeks (3 months post-intervention).

neoAGORA: Exploring Clinical Utility of Serial Liquid Biopsy (ctDNA) in Patients With Early-Stage Breast Cancer

The goal of this observational study is to explore the utility of analytical techniques that enable the study of small amounts of tumor-derived material circulating in the blood, such as fragments of circulating tumor DNA (also known as ctDNA), cells, or other particles. This type of sample is generally referred to as a liquid biopsy, and its analysis is a minimally invasive test, as it only requires the collection of blood samples. The study includes women and men with early-stage breast cancer (EBC) who are about to start neoadjuvant treatment (treatment given before surgery). The main questions it aims to answer are: * Can liquid biopsy analyses (ctDNA) provide additional information about the type of tumor before treatment starts? * Can these analyses help to detect early whether the tumor is responding to treatment? * Can these tests identify if any cancer remains after neoadjuvant treatment or after surgery? * Is this information related to the risk of the cancer coming back? * Can these analyses, when performed during follow-up, help detect cancer recurrence earlier? Participants will: * Continue receiving standard medical care for their breast cancer, including neoadjuvant therapy and surgery. * Provide blood samples at different time points during treatment and follow-up. * Provide residual tumor samples from the routine clinical care.

SHR-A1811 Versus Trastuzumab Plus Pertuzumab in ctDNA-Positive HER2-Positive Early Breast Cancer After Pathologic Complete Response

This investigator-initiated, single-center, randomized, open-label, phase II trial will evaluate the efficacy and safety of intensified adjuvant SHR-A1811 compared with trastuzumab plus pertuzumab in women with initially stage IIB-IIIC HER2-positive early breast cancer who achieved pathologic complete response after neoadjuvant systemic therapy and have detectable postoperative circulating tumor DNA (ctDNA). Eligible participants will be randomized 1:1 and stratified by hormone receptor status, HER2 test category, and initial clinical anatomic stage. The primary endpoint is invasive disease-free survival.