Clinical Research Directory

A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer. The goals are to establish the safety and efficacy of the combination therapy while establishing the optimal biologic doses. Patients will be administered a single infusion of CLBR001 cells followed by cycles of ABBV-461 with regular assessments of safety and disease response to treatment.

Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea

Why is this study being done? Many patients with a type of breast cancer (called HR-positive) take a medicine called Abemaciclib. While this medicine is effective, a very common side effect is diarrhea, which can be severe enough to disrupt treatment and reduce quality of life. The reason why some patients get diarrhea and others do not is not well understood. This study aims to investigate whether the natural bacteria living in the gut (known as the gut microbiome) play a role in this side effect. Researchers will compare the gut bacteria of patients who develop diarrhea with those who do not. What will happen in the study? This is an observational study, which means that patients will receive their normal cancer treatment and will not be given any new or experimental drugs as part of this initial phase. * Patients who are already being treated with Abemaciclib will be invited to join. * They will be placed into one of two groups: those who experience diarrhea and those who do not. * Participants will be asked to provide stool (feces) samples and may also provide optional blood samples at specific times during their treatment. * Researchers will analyze these samples in the lab to study the types and functions of the gut bacteria. Who can participate? * Adult women (aged 18-75) diagnosed with HR-positive breast cancer. * Currently receiving treatment with Abemaciclib for at least 2 weeks. * Must be willing to provide informed consent and follow the study procedures. What are the potential benefits? Participants will not receive any direct medical benefit from taking part in this study. However, the information learned may help researchers better understand why diarrhea occurs and, in the future, could lead to new ways to prevent or treat this side effect for other cancer patients. How is privacy protected? All personal information and samples collected will be de-identified using a unique code. This means that the data used for analysis cannot be directly linked back to the participant's identity. All data is stored securely according to strict ethical guidelines.

A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positive Breast Cancer

Hot flashes are among the most common and distressing adverse effects experienced by patients receiving endocrine therapy for hormone receptor-positive breast cancer. Hormone replacement therapy (HRT) and non-hormonal medications can alleviate symptoms but are limited by side effects and safety concerns, leading to poor adherence. Acupuncture, a traditional Chinese medical therapy involving percutaneous stimulation of specific acupoints, has shown potential to reduce the frequency and severity of hot flashes with minimal adverse events. This randomized, parallel-controlled clinical trial aims to evaluate the efficacy and safety of acupuncture in managing hot flashes in postoperative breast cancer patients undergoing endocrine therapy. Sixty eligible patients with stage I-III hormone receptor-positive breast cancer will be randomly assigned in a 1:1 ratio to receive either true acupuncture or sham acupuncture, three times per week for eight weeks, followed by a 16-week follow-up period without acupuncture. Functional magnetic resonance imaging (fMRI) will be employed to explore neural mechanisms underlying acupuncture's effects, alongside assessments of hot flash frequency, quality of life (FACT-B+ES), sleep quality (PSQI), and serum biomarkers related to endocrine and neuropeptide regulation. The results are expected to provide evidence for the efficacy and central mechanisms of acupuncture in managing hot flashes in breast cancer patients.

CDK4/6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment

Exploring the dynamics of ctDNA following neoadjuvant therapy with CDK4/6 inhibitors combined with endocrine treatment, and its potential to guide de-escalation of adjuvant chemotherapy

ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer

* This is a Phase II, multicenter, randomized clinical trial evaluating a ctDNA-guided approach to de-escalate adjuvant chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer. The study aims to determine if combining the CDK4/6 inhibitor Dalpiciclib with endocrine therapy can reduce the need for chemotherapy while maintaining clinical benefits. * Key Details ： 1. Participants: 393 women (aged 18-75) with early-stage HR+/HER2- breast cancer at high risk of recurrence (e.g., tumor size ≥2 cm, lymph node involvement, or high-grade tumors). 2. Design: Patients are randomized 1:4 to two groups: Group A (Chemotherapy) : Receives 4 cycles of taxane-based chemotherapy before surgery. Group B (Experimental) : Receives Dalpiciclib + aromatase inhibitor (AI) for 4 cycles pre-surgery. Post-surgery, treatment is adjusted based on ctDNA results. 3. Primary Goals ： Assess ctDNA clearance rate (conversion from detectable to undetectable ctDNA) after neoadjuvant therapy in Group B. Evaluate 3-year event-free survival (EFS) in Group B (e.g., freedom from cancer recurrence, progression, or death). Secondary Goals ： Safety of Dalpiciclib + endocrine therapy. Tumor response rates (e.g., complete cell cycle arrest, pathological remission). Correlation between ctDNA clearance and long-term outcomes. * Why This Matters ： Current guidelines recommend chemotherapy for high-risk HR+ breast cancer, but it often causes significant side effects. This study explores a personalized approach using ctDNA-a blood-based biomarker-to identify patients who may safely avoid chemotherapy without compromising survival. If successful, it could shift clinical practice toward less toxic, targeted therapies for eligible patients.

Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer

This clinical trial aims to evaluate the effectiveness of tirzepatide in achieving a 5% or more body weight reduction in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The study will also assess the safety and tolerability of tirzepatide, its feasibility based on discontinuation rates, and completion of treatment. Secondary objectives include evaluating 3-year invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), changes in BMI and body fat distribution, metabolic markers, and circulating tumor DNA (ctDNA).

Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4/6i, PIK3CA Inhibitors, or T-DXd

This is a real-world observational study aiming to evaluate the effectiveness of post-progression treatment strategies in patients with advanced breast cancer who have developed resistance to prior targeted therapies, including CDK4/6 inhibitors, PIK3CA inhibitors, trastuzumab deruxtecan (T-DXd), or other targeted agents commonly used in clinical practice. As resistance to these therapies becomes increasingly common, optimal sequencing strategies for subsequent treatment remain unclear. This study will collect clinical information on post-resistance systemic treatments and their outcomes, including progression-free survival, overall survival, and response rate. Baseline patient and tumor characteristics will also be collected to explore potential prognostic and predictive factors and to develop outcome prediction models that may help guide future clinical decision-making. This is a non-interventional study based on retrospective and prospective data from routine medical care. The results are expected to provide real-world evidence to inform personalized treatment strategies for patients with advanced breast cancer following resistance to targeted therapies.

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.