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Breast Neoplasms clinical trials

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NCT ID: NCT05043506 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies

EUCHARIS
Start date: September 30, 2021
Phase:
Study type: Observational

A retrospective observational analysis of de-identified data from a multinational medical record review to describe patient characteristics, treatment patterns, and effectiveness of palbociclib + AI as first-line therapy among adult patients with HR+/HER2- advanced breast cancer (ABC) in Europe

NCT ID: NCT05042999 Not yet recruiting - Clinical trials for Breast Neoplasm Female

VR Ultrasound-Guided Breast Biopsy

VRBB
Start date: September 2021
Phase: N/A
Study type: Interventional

To determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast biopsy procedure.

NCT ID: NCT05042791 Not yet recruiting - Clinical trials for HER2-positive Metastatic Breast Cancer

A Study of Pyrotinib Plus Capecitabine Combined With SRT in HER2+ MBC With Brain Metastases

Start date: September 30, 2021
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy and safety of SRT combined with pyrotinib and capecitabine in the treatment of patients with HER2-positive advanced breast cancer patients with brain metastases.

NCT ID: NCT05042687 Not yet recruiting - Breast Cancer Clinical Trials

Comparative Performance of Molecular Breast Imaging (MBI) to Magnetic Resonance Imaging (MRI) of the Breast in Identifying and Excluding Breast Carcinoma in Women at High Risk for Breast Cancer

Start date: September 30, 2021
Phase: Early Phase 1
Study type: Interventional

To evaluate the diagnostic performance of Tc99m sestamibi (MBI) compared to breast MRI in women who are at high risk for developing breast cancer. To assess the relationship of tumor size, histologic subtype and location of lesion and how it affects lesion conspicuity and sensitivity in MBI detected cancers.

NCT ID: NCT05041842 Not yet recruiting - Clinical trials for Metastatic Breast Cancer With a Isolated Brain Progression

Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer

InTTercePT
Start date: September 30, 2021
Phase: Phase 2
Study type: Interventional

The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group. These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease. The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment.

NCT ID: NCT05041751 Not yet recruiting - Breast Carcinoma Clinical Trials

Myofascial Release or Trigger Point Injections for the Reduction of Post-Mastectomy Pain Syndrome

Start date: October 30, 2021
Phase: N/A
Study type: Interventional

This clinical trial studies the effect of myofascial release in decreasing post-mastectomy pain compared to standard of care trigger point injections in patients with post-mastectomy pain syndrome. Patients who have mastectomies often experience pain that does not go away after time. This is known as post-mastectomy pain syndrome. Myofascial release is a form of physical therapy in which pressure is applied to the affected areas. Myofascial release may be an effective way of decreasing pain in patients with post-mastectomy pain syndrome without the use of medication.

NCT ID: NCT05040867 Not yet recruiting - Breast Cancer Clinical Trials

Exercise Prescription Guided by Heart Rate Variability in Breast Cancer Patients

Start date: September 13, 2021
Phase: N/A
Study type: Interventional

Breast cancer is a chronic disease that has seen a boom in research into its treatments, improvements and effects in recent decades. These advances have also highlighted the need to use physical exercise as a countermeasure to reduce the cardiotoxicity of pharmacological treatments. Patients need a correct daily individualisation of the exercise dose necessary to produce the physiological, physical and psychological benefits. To this end, the present study will use, in a novel way in this population, heart rate variability (HRV) as a measure of training prescription. The primary objective of this randomised clinical trial is to analyse the effects of a physical exercise programme planned according to daily HRV in breast cancer patients after chemotherapy treatment. For this purpose, a 16-week intervention will be carried out with 90 breast cancer patients distributed in 3 groups (control group, conventional preprogrammed physical exercise training group and physical exercise group with HRV daily programming). Cardiorespiratory capacity, strength, flexibility, agility, balance, body composition, quality of life, fatigue, functionality, self-esteem, anxiety and depression of patients before and after the intervention will be evaluated in order to compare the effects of exercise and its programming.

NCT ID: NCT05039931 Recruiting - Breast Cancer Clinical Trials

A Study of GNC-035, a Tetra-specific Antibody, in Participants With Locally Advanced or Metastatic Solid Tumors

Start date: June 8, 2021
Phase: Phase 1
Study type: Interventional

In this study, the safety, tolerability and preliminary effectiveness of GNC-035 in participants with locally advanced or metastatic solid tumors will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-035.

NCT ID: NCT05038735 Not yet recruiting - Breast Cancer Clinical Trials

Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

EPIK-B5
Start date: October 27, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4/6 inhibitor.

NCT ID: NCT05038137 Not yet recruiting - Breast Cancer Clinical Trials

Effects of Time Restricted Feeding on AGE-RAGE Signaling

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. There are 2 in-person study visits to have blood, urine and vital signs collected and 8 remote or phone visits with a psychologist to assist with the eating schedule. The study will take last 3 1/2 months.