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Breast Cancer clinical trials

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NCT ID: NCT05350722 Recruiting - Breast Cancer Clinical Trials

Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients

ABLATIVE-2
Start date: August 24, 2022
Phase: N/A
Study type: Interventional

In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.

NCT ID: NCT05350527 Recruiting - Breast Cancer Clinical Trials

Impact of Video Information Support on Preoperative Anxiety in Breast Cancer Surgery

SENEDOP
Start date: June 22, 2022
Phase: N/A
Study type: Interventional

The medical information delivered to the patient before any surgery constitutes an essential and compulsory step during the initial management of the operated patient. There are different reasons for the quantity and quality of medical information retained by the patient. An internet platform with personalized and secure access has been developed. This platform contains, among other things, an explanatory video of breast surgery and allows the patient to have access to information on surgical management at any time. The investigators believe that unlimited access for the duration of the study to this platform could reduce the preoperative anxiety level of patients.

NCT ID: NCT05350059 Not yet recruiting - Breast Cancer Clinical Trials

The HIFUB Study (HIFU in Breast Cancer)

HIFUB
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

High Intensity Focused Ultrasound (HIFU) is a new method of treating solid tumours by thermally ablating them. It has been used in a number of different types of cancers but there is little information on its use in invasive breast cancer (IBC). The investigators aim to assess the efficacy and safety of HIFU in the treatment of IBC. In this study, fifteen otherwise healthy women diagnosed with small, early stage IBC will be treated with HIFU prior to conventional surgical treatment. The effects of HIFU on the resected tumour will be analysed pathologically and correlated with radiological findings. Immune response and participant experience will also be evaluated

NCT ID: NCT05349227 Recruiting - Breast Cancer Clinical Trials

Comprehensive Outcomes for After Cancer Health

COACH
Start date: June 23, 2022
Phase: N/A
Study type: Interventional

This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 500 individuals with diverse cancer diagnoses will be enrolled across up to 5 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.

NCT ID: NCT05346510 Recruiting - Breast Cancer Clinical Trials

Prone Positioning CT Scan and Ultrasound Assessing Axillary Lymph Nodes in Patients With Breast Cancer Official Title: Evaluation of Axillary Lymph Nodes Using Prone Positioning Computed Tomography Scan and Ultrasound in Patients With Breast Cancer

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The early diagnosis and evaluation of breast cancer is of great significance to its treatment and prognosis. Among the multiple factors affecting the prognosis, the degree of axillary lymph node metastasis is one of the most vital factors. Accurately understanding the status of axillary lymph nodes prior to surgery allows better prediction of staging, enables correct treatment plans, and guides the scope of node dissection during surgery. For patients with early breast cancer or clinically negative axillary lymph nodes, sentinel lymph node biopsy (SLNB) can largely avoid complications such as upper extremity lymphedema caused by axillary lymph node dissection (ALND). Thus, clinical identification of negative lymph nodes becomes more valuable. Based on clinical verification, the NCCN guidelines (edition 2019) made the following recommendation: SLNB is performed for patients with clinically negative axillary lymph nodes, and the biopsy findings determine whether ALND is included; ALND is performed for patients with clinically positive axillary nodes. Currently, imaging examinations have limitations is assessing axillary lymph nodes. Finding an accurate and non-invasive method in preoperative axillary assessment has been a project that needs to be urgently addressed. Ultrasonography has advantages in its simplicity, non-invasiveness, economy, and on radiation, however it is highly subjective, dependent upon examiner's experience and knowledge, and is difficult to detect deeper and small lesions. Molybdenum Target examination plays an important role in diagnosis of breast cancer, however it is expensive and limited in evaluating the whole axilla. PET-CT is restricted by its high cost and is not a routine examination in China. Therefore, computed tomography (CT) scan is more advantageous in determination of lymph node metastasis. The 2014 GORO KUTOMI study suggested that lymph node morphology assessed as clear by preoperative CT was an independent predictor of sentinel lymph node metastasis. CT scan can not only evaluate the presence or absence of distant metastasis and pectoralis muscle invasion, but also provide intuitive, accurate and detailed evaluation of axillary, supraclavicular, and pectoralis major intramuscular lymph nodes. The diagnostic criteria of magnetic resonance imaging (MRI) is relatively vague; CT can also obtain imaging data of the lungs, mediastinum, whereas MRI has no such function. Based on previous studies, we will further explore and evaluate axillary node status using prone positioning CT scan and ultrasound in patients with breast cancer.

NCT ID: NCT05346328 Not yet recruiting - Breast Cancer Clinical Trials

HER2-positive Breast Cancer Project Initiated by Investigators

Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

This study will assess the objective response rate (ORR), safety, progression-free survival (PFS) , overall survival (OS), 6-month survival rate, 12-month survival rate, 18-month survival rate, 24-month survival rate, disease control rate (DCR), clinical benefit rate (CBR), duration of response (DOR) and Time to Response (TTR). Injection of A166 for HER2-positive patients with refractory unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug therapy.

NCT ID: NCT05346224 Active, not recruiting - Breast Cancer Clinical Trials

A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer

Start date: April 25, 2022
Phase: Phase 3
Study type: Interventional

This is a phase III, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of pertuzumab biosimilar HLX11 vs. EU-Perjeta® on HER2-positive and HR-negative early-stage or locally advanced breast cancer with a primary tumor > 2 cm. Patients are random assignment to 2 arms and treatment with either HLX11 or EU-Perjeta® , and received neoadjuvant THP regimen every 3- weeks 4 cycles,adjuvant AC every 3- weeks 4 cycles and pertuzumab+trastuzumab(HP) every 3- weeks 13cycles.

NCT ID: NCT05346107 Recruiting - Breast Cancer Clinical Trials

PLD-cyclophosphamide-Nab-P Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer

Start date: January 1, 2020
Phase: Phase 2
Study type: Interventional

patients with HER2-positive breast cancer (cT2-3/N0-1/M0) were treated with PldCHP (pegylated liposomal doxorubicin 35mg/m2, cyclophosphamide 600mg/m2, trastuzumab 8 mg/kg loading, then 6 mg/kg, pertuzumab 840 mg loading, then 420 mg, iv, q3w) for 4 cycles followed by Nab-PHP (Nab-Paclitaxel 260mg/m2, trastuzumab 6 mg/kg, pertuzumab 420 mg, iv, q3w) for 4 cycles

NCT ID: NCT05341141 Recruiting - Breast Cancer Clinical Trials

Effectiveness of Cryotherapy Combined With Compression Therapy for Preventing Chemotherapy-induced Peripheral Neuropathy

Start date: June 10, 2022
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, randomized study designed to evaluate the clinical efficacy of cryotherapy combined with compression therapy in preventing albumin-paclitaxel induced peripheral neuropathy.

NCT ID: NCT05339685 Recruiting - Breast Cancer Clinical Trials

A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer or Other Solid Tumors

Start date: May 20, 2022
Phase: Phase 1
Study type: Interventional

In phase Ia study, the safety and tolerability of BL-M02D1 in patients with locally advanced or metastatic triple negative breast cancer or other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M02D1. In phase Ib study, the safety and tolerability of BL-M02D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M02D1 in patients with locally advanced or metastatic triple negative breast cancer or other solid tumors will be evaluated.