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Breast Neoplasms clinical trials

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NCT ID: NCT05306041 Recruiting - Clinical trials for HER2-positive Breast Cancer

Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer

GeparPiPPa
Start date: January 2, 2023
Phase: Phase 2
Study type: Interventional

Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.

NCT ID: NCT05305963 Recruiting - Clinical trials for Breast Cancer Female

Breast CANcer Risk Assessment in Younger Women: BCAN-RAY

BCAN-RAY
Start date: January 31, 2023
Phase:
Study type: Observational

The overarching aim of the proposed research is to develop a comprehensive breast cancer risk assessment strategy for women aged 30-39 years. There are three main objectives to the study. Objective 1 - Mammographic Density and Risk To define the magnitude of BC risk associated with MD in women aged 30-39 and facilitate its incorporation into risk prediction models. Objective 2 - Psychological impact To examine the feasibility of a strategy to offer breast cancer risk-assessment to diverse ethnic and socioeconomic populations of women in their 30s, assessing: - Potential benefits and harms - Impact on health inequalities - Acceptability Objective 3 - DNA Methylation substudy To explore the potential of DNA Methylation (DNAme) signatures from self-obtained cervical samples to further refine risk prediction algorithms

NCT ID: NCT05305937 Not yet recruiting - Clinical trials for Malignant Tumor of Breast

Implantation of CEST and CESL MRI Methods for Detection of Breast Tumors

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

MRI is a well-established method in breast imaging. It gives excellent morphological information but does not reflect the metabolic activity leading to high proportion of false positive results. PET-CT fulfills this gap but suffers from low resolution and the risk of radiation damage. Lately, chemical exchange saturation transfer (CEST) MRI of glucose has been proposed as a new molecular imaging approach for diagnosing tumors given its high sensitivity at the molecular level and the known enhanced glucose uptake by tumors. Several glucose analogs were examined as possible candidates for imaging of breast tumors. One of the most promising agent for CEST-MRI is glucosamine (GlcN); owing to its phosphorylated products that accumulate in breast tumors, it enables to reflect their metabolic profile. In preclinical experiments glucosamine exhibits enhanced CEST signals in 4T1 and MCF7 implanted breast cancer cells in mice. Its potential for the human clinical application is strengthened by its lack of toxicity. Here the investigators propose to test the method for human subjects on a clinical MRI setup. The goal of this study is to develop innovative molecular imaging modality based on CEST-MRI of GlcN for the detection of breast tumors. The investigators will use the newly developed CEST-MRI modality for the detection of benign and malignant breast cancer in a clinical MRI scanner. .

NCT ID: NCT05305924 Recruiting - Clinical trials for HER2-negative Breast Cancer

Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer

Start date: February 25, 2021
Phase: Phase 2
Study type: Interventional

The study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage such patients.

NCT ID: NCT05305092 Recruiting - Breast Cancer Clinical Trials

Assessment of Brain Cognitive Impairment in Breast Cancer

Start date: May 31, 2022
Phase:
Study type: Observational

To explore the cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients and to find biomarkers with early predictive effect on this cognitive impairment by using multimodal integrated PET/MRI technology combined with psychobehavioral technology.

NCT ID: NCT05304962 Recruiting - Breast Cancer Clinical Trials

First-in-Human Study of RGT-419B Alone and With Endocrine Therapy in Subjects With HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer

Start date: March 4, 2022
Phase: Phase 1
Study type: Interventional

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal Therapy in subjects with HR+, HER2- locally advanced and unresectable (Stage III) or metastatic (Stage IV) breast cancer whose disease has progressed during prior therapy with an approved CDK4/6i plus hormonal therapy.

NCT ID: NCT05303675 Recruiting - Clinical trials for Breast Cancer Female

The Effect of Arm Exercises on Arm Oedema After Breast Cancer Surgery

Start date: April 18, 2022
Phase: N/A
Study type: Interventional

In order to prevent lymphedema after breast surgery, patients are advised to know the risk factors for lymphedema and to avoid situations that may cause lymphedema, to perform active and passive arm exercises, to evaluate the affected area for lymphedema, to perform self-care and this should be under the self-management of the patients. Investigators think that this study will have a positive effect on the literature since there are no studies on risk scoring, the combined use of training and exercises to strengthen self-care skills in preventing the development of breast cancer-associated lymphedema. From this point of view, the study was planned as a randomized controlled experiment to examine the effects of preoperative lymphedema scoring and postoperative progressive upper extremity exercises on upper extremity function and self-care in women with breast cancer.

NCT ID: NCT05303129 Active, not recruiting - Breast Cancer Clinical Trials

Prognostic Impact of the Neutrophil/Lymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4/6 Inhibitor.

PEPSI
Start date: May 27, 2022
Phase: N/A
Study type: Interventional

The impact of the inflammatory microenvironment in predicting the benefit of a CDK4/6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied. We propose a multicenter prospective study to confirm the prognostic value of pre-therapy NLR on progression-free survival of patients initiating treatment with a CDK4/6 inhibitor combined with hormonal therapy for locally advanced or metastatic HR-pos / HER2-neg breast cancer. We will also evaluate other markers of inflammation and their prognostic and predictive value for a better response to CDK4/6 inhibitor therapy in combination with hormone therapy in these patients. Specific blood tests (lymphocyte typing) will be performed during treatment with CDK4/6.

NCT ID: NCT05303038 Recruiting - Clinical trials for Metastatic Breast Cancer in the Liver

Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic TNBC Patients Failed by Multiline Therapy

Castle06(BC)
Start date: May 1, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase II, open-label study evaluating the efficacy and safety of Cryoablation combined with Tirelizumab and Bevacizumab in liver metastatic triple-negative breast cancer patients failed by multiline therapy.

NCT ID: NCT05302778 Recruiting - Breast Cancer Clinical Trials

Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer

HERMIONE-10
Start date: March 22, 2021
Phase:
Study type: Observational

Multicenter, retrospective and prospective, cohort, observational study evaluating the clinical efficacy and tolerability of Eribulin as second-line treatment in accordance with the indications authorized by AIFA in patients with triple negative advanced breast cancer in a real world setting.