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About This Study

The aim of this study is to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) combined with complete decongestive therapy (CDT) compared with CDT alone in patients with breast cancer-related lymphedema. Female patients with unilateral Stage II upper-extremity lymphedema related to breast cancer will be included. Participants will receive either complete decongestive therapy alone or complete decongestive therapy combined with extracorporeal shock wave therapy. Clinical outcomes will be evaluated before treatment, immediately after treatment, and at 1 and 3 months after treatment. Primary outcomes will include limb circumference difference, volumetric measurements, and ultrasonographic assessment of skin and subcutaneous tissue thickness. Secondary outcomes will include upper-extremity function, quality of life, and pain.

Design

Interventions / Regimen

• Other: Complete Decongestive Therapy — Complete decongestive therapy will consist of manual lymphatic drainage performed by an experienced physiotherapist according to the Vodder technique for 45-60 minutes, followed by multilayer short-stretch bandaging and lymphedema exercises performed under the supervision of the physiotherapist. Treatment will be administered five sessions per week for a total of 15 sessions. Arm Cross-Reference: Complete Decongestive Therapy Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy
• Device: Extracorporeal Shock Wave Therapy — Radial extracorporeal shock wave therapy will be administered using a pressure of 2 bar, a frequency of 4 Hz, and a total of 2,500 shocks per session. The shocks will be distributed as follows: Axillary region: 750 shocks Upper arm: 500 shocks Cubital region: 250 shocks Forearm: 500 shocks Dorsum of the hand: 500 shocks ESWT will be administered three sessions per week for three weeks. Arm Cross-Reference: Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy

Primary Outcomes

• Change in Upper-Extremity Circumference Difference (Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.)
• Change in Upper-Extremity Volume (Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.)
• Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography (Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.)

About This Study

This multicenter, open-label, prospective, randomized controlled study compares a novel endoscopy-assisted breast-conserving surgery technique (SRRSHzb-EABCS) with conventional open breast-conserving surgery (CBCS) in women with breast cancer who wish to preserve their breast. Breast-conserving surgery followed by radiotherapy is a standard treatment for early-stage breast cancer. Conventional open surgery leaves visible scars on the breast, while traditional endoscopy-assisted techniques are time-consuming, difficult to learn, and costly. The investigators developed a novel technique, SRRSHzb-EABCS, which uses a gasless expansion-traction endoscopic system with a custom-built skin flap dissector and V-shaped retractor, together with percutaneous U-shaped metal wires placed around the marked tumor margin, enabling precise tumor localization and margin control through a single axillary incision. The technique is designed to be easier to learn, shorter in operative time, less expensive, and more cosmetic. Eligible participants are randomly assigned in a 1:1 ratio to undergo either SRRSHzb-EABCS or conventional open breast-conserving surgery. The main goal of the study is to compare the intraoperative and postoperative positive margin rates between the two techniques. The study also compares aesthetic outcomes measured by BREAST-Q scores at 1 and 18 months after surgery, complication rates, and 5-year local recurrence, disease-free survival, and overall survival. A total of 422 participants (211 per arm) will be enrolled at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and multiple participating centers in China. Participants are followed at 1 month and 18 months after surgery, with long-term follow-up for up to 5 years.

Design

Interventions / Regimen

• Procedure: Endoscopy-assisted breast-conserving surgery (SRRSHzb-EABCS) — A novel gasless endoscopy-assisted breast-conserving surgery using an expansion-traction system (a skin flap dissector and a V-shaped retractor) and a metal wire-based tumor localization system. Through a single 3.0-4.5 cm axillary incision, the retromammary space is created endoscopically. The resection margin is marked 1.5-2.0 cm beyond the tumor edge; U-shaped cutting wires and marking wires are placed percutaneously. The flap is dissected while the V-shaped retractor maintains the working space. Each cutting wire is energized with an electrocautery pencil to cut along the planned margin ("hot-wire" cutting). Margins are assessed by frozen section; positive margins undergo local re-excision, and repeatedly positive margins lead to mastectomy. Axillary management: sentinel lymph node biopsy (SLNB) for clinically node-negative patients, with axillary lymph node dissection (ALND) performed according to biopsy results; clinically node-positive patients undergo ALND directly.
• Procedure: Conventional open breast-conserving surgery (CBCS) — Conventional open breast-conserving surgery performed according to the Chinese Anti-Cancer Association guidelines for breast-conserving therapy. Generally, separate incisions are made on the breast and in the axilla. The resection includes the tumor together with a margin of surrounding breast tissue. Specimen margins are marked and assessed (inking and/or intraoperative frozen section). Four to six titanium clips are placed in the tumor bed for radiation boost localization. Oncoplastic volume displacement or volume replacement techniques are applied when needed. If a margin is positive on intraoperative or postoperative pathology, local re-excision of the margin is performed, and if margins remain repeatedly positive, mastectomy is performed. Axillary management: sentinel lymph node biopsy (SLNB) for clinically node-negative patients, with axillary lymph node dissection (ALND) performed according to biopsy results; clinically node-positive patients undergo ALND directly.

Primary Outcomes

• Intraoperative and Postoperative Positive Margin Rate (Intraoperatively and up to 1 month after surgery (final pathology report))

About This Study

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.

Design

Interventions / Regimen

• Drug: MDX2001 — MDX2001 intravenous infusion or subcutaneous (SC) injection.

Primary Outcomes

• All Phases: Adverse events (AEs) (Baseline until end of study, up to approximately 9 months)
• Phase 1b and Phase 2a: Objective response rate of MDX2001 (From date of enrollment until the end of treatment, up to approximately 6 months)
• Phase 1: Recommended Phase 2 dose (RP2D) (Baseline until end of study, up to approximately 9 months)

About This Study

The goal of this observational study is to develop and validate an artificial intelligence (AI) model for predicting the risk of distant metastasis in patients with primary breast cancer. The main question it aims to answer is: Can a multimodal AI model, trained on routinely available histopathological images, accurately predict the long-term risk of breast cancer metastasis? Researchers will analyze existing hematoxylin and eosin (H\&E) and immunohistochemistry (IHC) stained tissue slides from patients who underwent surgery between 2015 and 2025. Clinical data will be used to train the AI model and evaluate its performance in predicting metastasis.

Design

Interventions / Regimen

• Other: Diagnostic Test: AI-Based Spatial Pathomic Analysis — This is an observational study with no therapeutic or procedural interventions. The "intervention" refers to the analytical method applied to existing data. Archived tissue samples (H\&E and IHC stained slides) will be digitally scanned and analyzed by a multimodal artificial intelligence (AI) model to develop a risk prediction tool for distant metastasis. Patients' clinical data will be collected for model training and validation. No direct interaction with patients occurs, and no treatment decisions are influenced by this study.

Primary Outcomes

• Predictive accuracy for distant metastasis risk assessed by Time-dependent Area Under the Receiver Operating Characteristic Curve (Time-dependent AUC) (From the date of initial surgery up to 5 years post-operatively, with the occurrence of distant metastasis defined as the event of interest.)

About This Study

Iparomlimab and Tuvonralimab Injection (QL1706) is a bifunctional combination antibody targeting both programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen 4 (CTLA-4). This is a prospective clinical study that plans to enroll screened, eligible early-stage breast-cancer patients to receive neoadjuvant QL1706 plus chemotherapy (four cycles of TP ± four cycles of AC). After the four TP cycles, imaging and core biopsy will be performed. Patients who achieve radiologic complete response will proceed directly to surgery; those who do not will receive four additional AC cycles before surgery. A key feature is the incorporation of an response-guided neoadjuvant therapy（RGN）model to identify sensitive patients who can forgo anthracyclines, thereby reducing long-term cardiotoxicity.

Design

Interventions / Regimen

• Drug: QL1706 combined with Chemotherapy — Participants receive QL1706 every 3 weeks (Q3W) + Albumin-bound paclitaxel every 3 weeks (Q3W) + Cisplatin (Q3W) x 4 cycles. After the four TP cycles, imaging and core biopsy will be performed. Patients who achieve radiologic complete response will proceed directly to surgery; those who do not will receive QL1706 Q3W + epirubicin Q3W + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy before surgery.

Primary Outcomes

• tpCR（ypT0/is ypN0） (Up to approximately 27-30 weeks)

About This Study

The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). The main questions it aims to answer are: * Can detailed immune profiling of the tumor and its microenvironment predict pathological complete response (pCR, RCB-0) versus partial/non-response (RCB-I, II, III) to neoadjuvant immunochemotherapy? * Are there specific immune or molecular biomarkers (e.g., TILs, CD3/8/20, FoxP3, PDL1, transcriptomic signatures) associated with progression-free survival and overall survival in this population? Researchers will compare patients achieving pCR (RCB-0) to those with residual disease (RCB-I, II, III) to determine if immune and molecular profiles can discriminate responders from non-responders and guide personalized treatment strategies.

Design

Interventions / Regimen

• Biological: Additionnal breast biospy and blood sample — Tumor biopsy during intra-tumoral clip placement (pre-treatment) and annual blood samples (20 mL) for 5 years, in addition to standard follow-up.

Primary Outcomes

• Comparison of Immune Determinants According to Response to Neoadjuvant Immunochemotherapy (Baseline (pre-treatment tumor biopsy) and up to 5 years (annual blood samples and clinical follow-up).)
• Comparison of Immune Determinants According to Progression-Free Survival (PFS) (From baseline (pre-treatment) through 5 years of follow-up.)
• Comparison of Immune Determinants According to Overall Survival (OS) (From baseline (pre-treatment) through 5 years of follow-up)

About This Study

This interventional prospective study aims firstly to investigate variations in lipid levels in blood samples and their potential relationship with the duration and/or intensity of post-operative pain. Secondly, it aims to investigate the activation of peripheral blood mononuclear cells and neutrophils in patient blood samples. The study will enrol women aged 18 years or older who have been newly diagnosed with primary invasive or non-invasive breast cancer requiring surgical removal of the tumour, with or without axillary surgery. The main objectives of the study are To assess whether there is an association between circulating levels of lipid mediators and chronicity (\> 3 months) of postoperative pain after breast cancer surgery. To assess whether circulating levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery. To assess the existence of an association between resected tissue levels of lipid mediators and chronicity of postoperative pain in breast cancer surgery. To assess whether tissue levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.

Design

Interventions / Regimen

• Other: Blood sample + questionnaire — * blood sample before tumor surgery and at every follow-up visit * questionnaire before tumor surgery and at every follow-up visit

Primary Outcomes

• Pain intensity (Throughout the study, an average of 2 years)
• Pain duration (Throughout the study, an average of 2 years)
• Lipid Mediator Levels in Blood (Throughout the study, an average of 2 years)

About This Study

This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.

Design

Interventions / Regimen

• Procedure: Omission of surgical treatment — Omission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy

Primary Outcomes

• Event-free survival (5 years)

About This Study

This study is a single-center, multi-cohort, phase II clinical trial. Eligible patients with HER2-positive advanced solid tumors were enrolled after providing informed consent. A total of 90 patients were allocated into three cohorts (30 patients each): those with Extramammary Paget's Disease (EMPD), rare solid tumors, or urothelial carcinoma, who had experienced failure of standard treatment or for whom no standard treatment was available. The participant recruitment period was 12 months, and the follow-up duration was 12 months. All patients received Trastuzumab Rezetecan (SHR-A1811) at a dose of 4.8 mg/kg administered every three weeks (q3w). They were followed until disease progression, withdrawal from the study, loss to follow-up, or death, whichever occurred first. Tumor response was assessed radiologically every 6 weeks during treatment. Safety follow-up was conducted 30 days after the last dose, followed by survival follow-up every 3 months thereafter.

Design

Interventions / Regimen

• Drug: SHR-A1811 — Trastuzumab Rezetecan (SHR-A1811) is administered at a dose of 4.8 mg/kg every 21 days (q3w), constituting one treatment cycle.
• Drug: Trastuzumab Rezetecan — Patients who have failed standard therapy are treated with Trastuzumab Rezetecan

Primary Outcomes

• The proportion of patients who achieved CR or PR according to RECIST V.1.1 criteria. (Efficacy was assessed every 9 weeks for 1 year and every 12 weeks thereafter (assessed up to 3 years).)

About This Study

A Prospective, multicenter, randomized controlled phase II study to evaluate the efficacy and safety of PD-L1 monoclonal antibody combined with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy and concurrent or delayed radiotherapy in patients with advanced HER2-negative breast cancer with brain metastasis

Design

Interventions / Regimen

• Drug: Adebrelimab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy — 1. Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w). 2. VEX Metronomic Chemotherapy: Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: The interval between radiotherapy and immunotherapy should be within 3 weeks, with no specific order required. Different radiotherapy techniques will be selected based on the size and location of the metastatic lesions: Stereotactic Body Radiation Therapy (SBRT), Spatially Fractionated Radiation Therapy (SFRT), Low-dose Radiotherapy (LDRT).
• Drug: Adebrelimab+VEX Metronomic Chemotherapy+Delayed Radiotherapy — 1. Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w). 2. VEX Metronomic Chemotherapy: Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: If there is intracranial disease progression but extracranial disease remains stable, the systemic treatment regimen of Adelumab + VEX metronomic chemotherapy will be continued, with the addition of intracranial radiotherapy. If there is intracranial disease progression and extracranial disease progression, the systemic treatment regimen will be modified, with the addition of intracranial radiotherapy. The radiotherapy positioning and techniques will be the same as those used in the experimental group.

Primary Outcomes

• Intracranial Progression-Free Survival (iPFS) (24 months)

About This Study

Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy

Design

Interventions / Regimen

• Radiation: Hypofractionated Radiation Therapy — Hypofractionated breast radiotherapy (HFRT) with hybrid techniques combining field-in-field intensity-modulated RT (FIF-IMRT) to the whole breast with inverse-IMRT for concomitant boost

Primary Outcomes

• Ipsilateral breast tumor recurrence (From enrollment to the end of treatment at 2 years)

About This Study

Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis

Design

Interventions / Regimen

• Drug: Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir — Intrathecal chemotherapy group Patients received intrathecal 150mg Trastuzumab combination with 10mg thiotepa once every three weeks until an event that meets the criteria for termination occurs.

Primary Outcomes

• Intracranial Overall Response Rate (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)