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Breast Cancer clinical trials

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NCT ID: NCT04950010 Terminated - Breast Cancer Clinical Trials

High-intensity Exercise After Treatment

HEAT
Start date: March 28, 2022
Phase: N/A
Study type: Interventional

This pilot study tests the feasibility and preliminary efficacy of an 8-week, 3-arm pilot exercise trial in which 45 breast cancer survivors will be randomized to high-intensity interval training (HIIT; n=15), moderate-intensity aerobic training (MOD; n=15), or Usual Care (UC; n=15).

NCT ID: NCT04947917 Terminated - Breast Cancer Clinical Trials

Axillary Lymph Node Tattoo Marking Study

Start date: December 29, 2021
Phase: N/A
Study type: Interventional

This research study investigates if SpotTM ink can help breast surgeons retrieve sampled lymph node as well as or better than the standard clip and radioseed guidance methods. The names of the novel study intervention involved in this study is: - SpotTM ink tattooing The names of the standard of care study interventions involved in this study are: - Core needle biopsy and/or fine needle aspiration - Surgical Removal of the Lymph Nodes via clip and radioseed guidance

NCT ID: NCT04936451 Terminated - Breast Cancer Clinical Trials

Electrotherapy in the Management of Myofascial Syndrome

MODYMYO
Start date: January 5, 2022
Phase: N/A
Study type: Interventional

Myofascial syndrome is defined as "musculoskeletal pain characterized by local and referred pain perceived to be deep and constant, and by the presence of myofascial trigger points in any part of the body" Post-breast surgery myofascial syndrome affects up to 44.7% of operated women, mainly on the muscles of the greater shoulder girdle. The repercussions are significant, functional, somatic, psychological and socio-professional affecting the quality of life. The treatments offered may or may not be medicinal. Transcutaneous electrical nerve stimulation (TENS) is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.

NCT ID: NCT04932031 Terminated - Breast Cancer Clinical Trials

Risk Prediction of Taxane Chemotherapy-Induced Peripheral Neuropathy

SENSE
Start date: May 25, 2022
Phase:
Study type: Observational

This is an observational study to discover risk factors of chemotherapy-induced peripheral neuropathy (CIPN) in 350 patients with early stage breast cancer undergoing taxane-based chemotherapy at two main sites (University of North Carolina at Chapel Hill (UNC) Hospital, including Rex Hospital, and the University of Alabama at Birmingham (UAB) Hospital). The primary purpose of this study to explore patient- and procedure-based variables that identify patients at risk for developing CIPN during chemotherapy.

NCT ID: NCT04927481 Terminated - Breast Cancer Clinical Trials

A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer

Start date: June 11, 2021
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label, single-arm, phase II study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in patients with advanced HER2 negative breast cancer.

NCT ID: NCT04899349 Terminated - Breast Cancer Clinical Trials

Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant

EPIK-B4
Start date: April 6, 2022
Phase: Phase 2
Study type: Interventional

This study was designed to assess the safety and efficacy of the combination of dapagliflozin plus metformin extended release (XR) compared with metformin XR during treatment with alpelisib plus fulvestrant in participants with Hormone Receptor (HR)-positive, Human Epidermal growth factor Receptor-2 (HER2)-negative advanced breast cancer with a Phosphoinositide-3-Kinase Catalytic subunit Alpha (PIK3CA) mutation following progression on or after endocrine-based therapy.

NCT ID: NCT04875806 Terminated - Breast Cancer Clinical Trials

A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors

Start date: June 30, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This research study is studying a new drug, NC762, as a possible treatment for advanced or metastatic solid tumors.

NCT ID: NCT04815291 Terminated - Breast Cancer Clinical Trials

Streamlined Localization Using SCOUT® at Biopsy (STREAMLoc )

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

This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.

NCT ID: NCT04784182 Terminated - Clinical trials for Breast Cancer Female

Anti-anxiety Biotics for Breast Cancer Survivors

ABBCS
Start date: July 20, 2021
Phase: N/A
Study type: Interventional

Cancer survivors experience more rapid declines in health-related quality of life which include physical and psychological comorbidities, the latter of which may be subclinical and often overlooked by primary care providers. Recently, the gut-brain axis (GBA) has been identified as a therapeutic target to improve host health. The GBA is greatly influenced by the composition of the gut microbiome, as microbial metabolites directly influence the central nervous system. Thus, prebiotics, probiotics, and synbiotics (a combination of pre- and probiotics) have emerged as a possible approach to treating anxiety symptoms. Preclinical studies suggest efficacy of synbiotics, while pre- and probiotics have only been studied in isolation in humans. This is a double-blind, placebo-controlled clinical trial in which female breast cancer survivors and/or their female relatives experiencing moderate to severe anxiety symptoms will be randomized to daily consumption of the synbiotic supplement or placebo. The previously validated Generalized Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptom severity at study screening and at each time point. The primary outcome of this study is feasibility, measured by accrual, adherence, retention, and adverse effects. Secondary outcomes relate to reduction of anxiety symptoms and other physiological changes. No study has investigated the mediating effects of gut microbiota and inflammatory markers on the ability of synbiotics to reduce anxiety symptoms. Thus, at each timepoint, phlebotomy will be conducted to determine serum levels of inflammatory cytokines and stool samples will be collected to determine alpha- and beta-diversity of the fecal microbiome as well as relative abundance of target genera. Hypothesis: this placebo-controlled study will be feasible and synbiotic treatment will result in a significant reduction in anxiety symptoms and inflammatory markers, which may be moderated by changes in the microbiome.

NCT ID: NCT04720664 Terminated - Breast Cancer Clinical Trials

Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer

OASIS
Start date: September 22, 2021
Phase: Phase 2
Study type: Interventional

This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer. It is designed to determine efficacy, defined as the objective response rate (ORR) of this investigational treatment. It is hypothesized that SM-88 used with MPS will lead to significant anti-tumor responses with acceptable toxicities in patients with metastatic HR+/HER2- breast cancer.