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Breast Neoplasms clinical trials

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NCT ID: NCT06409390 Recruiting - Clinical trials for Metastatic Breast Cancer

Pilot Study of Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

Start date: May 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of the study is to test a treatment strategy with currently approved drugs to see if it is practical to administer the available drugs in a new way that researchers hope could be more effective in treating metastatic breast cancer.

NCT ID: NCT06407037 Recruiting - Postoperative Pain Clinical Trials

Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block

Start date: December 27, 2023
Phase: N/A
Study type: Interventional

Breast cancer is the most common malignancy in women. Modified radical mastectomy, a surgical procedure in the treatment of breast cancer, is one of the standard treatments. Postoperative pain can seriously reduce the quality of life in patients, and inadequately treated acute pain can trigger chronic pain syndrome. Therefore, thoracic paravertebral block and thoracic epidural block are effective in postoperative analgesia. However, the use of these blocks is limited due to complications. In recent years, less invasive blocks, such as pectoral nerve block (PECS I-II), Serratus anterior plane block (SAPB), Erector spinae plane block (ESPB), and Serratus Posterior Superior intercostal Plane Block (SPSİPB) have been applied. In this study, it was aimed to compare the analgesic effectiveness of ESPB and SPSİPB applications in patients undergoing breast surgery.

NCT ID: NCT06406868 Recruiting - Breast Cancer Clinical Trials

Outpatient Versus Tele Rehabilitation Among Post-surgical Breast Cancer Survivors

Start date: February 7, 2024
Phase: N/A
Study type: Interventional

This study is comparing two interventions to identify effective treatment for breast cancer patients.

NCT ID: NCT06406127 Recruiting - Breast Cancer Clinical Trials

Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients

Start date: April 1, 2024
Phase: Phase 4
Study type: Interventional

92 female cancer patients, aged from 18 to 75 years old (with a first diagnosis of breast cancer) who will receive Paclitaxel-based chemotherapy (12 weeks) as first line therapy, will be enrolled in the study and will be randomly assigned to either: - Group I: will receive the chemotherapy protocol or - Group II: will receive the chemotherapy protocol plus 600 mg daily dose of Alpha Lipoic Acid for 14 weeks (one week before the start of paclitaxel and continue till one week after the end of paclitaxel). * Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study) - Tumor Necrotizing Factor- alpha (TNF-α) by ELISA. - Brain-Derived Neurotrophic Factor (BDNF) by ELISA. * All patients will be subjected to 6 tests/questionnaires (week 1 - week 12 - week 24) to predict the functionality of the brain: - Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) version 3 - Mini-Cog Test - Mini Mental State Examination (MMSE) - Controlled Oral Word Association Test (COWAT) - Hopkins Verbal Learning Test (HVLT) - Trail Making Test (TMT)

NCT ID: NCT06404983 Recruiting - Breast Cancer Clinical Trials

Opioid-free Anaesthesia in Breast Cancer Surgery

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

Background: Various analgesic modalities are adopted for perioperative analgesia in breast cancer surgeries. Opioid-free and opioid-sparing techniques are gaining popularity due to the lack of opioid-dependent undesirable effects, including respiratory depression, urinary retention, nausea and vomiting, constipation, itching, opioid-induced hyperalgesia, tolerance, addiction, and immune system disorders. The goal of this prospective randomized clinical trial is to investigate the impact of opioid-free anaesthesia (OFA) versus conventional general anaesthesia (CGA) on postoperative analgesic requirements after breast cancer surgery (lumpectomy/mastectomy, with or without axillary lymph node excision). Secondary objectives include comparative perioperative evaluation of cognitive function and postoperative adverse events during the first 48 hours atfter surgery. Comparative evaluation of intraoperative haemodynamics and hospital length of stay are also secondary objectives, as well as the incidence of neuropathic pain assessed by validated questionnaires at 3 and 6 months postoperatively. During the preoperative screening, body measurements, age, gender, ASA (American Society of Anesthesiologists) physical status classification, educational level (using a 6-level scale: elementary, middle school, high school, higher education, higher education, and postgraduate/doctoral degree), home medication, and comorbidities (using the Charlson Comorbidity Index) are recorded. Intraoperatively, the duration of anaesthesia, duration of surgery, associated intraoperative data (e.g., haemodynamic instability, adverse effects associated with protocol-administered pharmaceutical agents, etc.), and medications administered (type and quantity) are recorded. The investigators expect to recruit at least 100 participants per group.

NCT ID: NCT06404697 Recruiting - Breast Cancer Clinical Trials

Boost Irradiation to the Supraclavicular Area Among High Risk cN3c Breast Cancer Patients

Start date: May 2024
Phase: Phase 2
Study type: Interventional

cN3c breast cancer with ipsilateral supraclavicular (SCV) lymph nodal (SCLN) metastasis is known to have a dismal prognosis. Currently, the combined-modality therapy consisting of primary systemic therapy (PST), subsequent local and/or systemic therapy based on response is the standard of care. However, the value of giving radiotherapy (RT) boost to SCV region remains uncertain in cN3c patients. This study aimed to assess the efficacy and safety of RT boost to the SCV area in high-risk cN3c breast cancer patients based on nodal response following PST.

NCT ID: NCT06403904 Recruiting - Breast Cancer Clinical Trials

Assessing Clinical Features and Outcome of Breast Cancer in PALB2 Mutation Carriers: the Palbreast Study

PALBREAST
Start date: October 2, 2023
Phase:
Study type: Observational

The Modena hereditary breast cancer group identified 3498 BRCA test candidates affected by breast cancer (BC). Among those, 392 were BRCA1/2 positive (11.2%). Since 2018, the site started to analyze eligible BC patients by multi gene panel (MGP) test. Fifty hundred sixty BRCA negative patients have been recalled, whereas other 934 were firstly analyzed by MGP. Totally, among 1494 BC patients analyzed by MGP test, 33 were PALB2 mutation carriers (2%). By involving the Italian Society of Genetic Oncology and 11 European Institutions, it is calculated to identify about 300 PALB2 mutation carriers. PALB2 is a breast cancer susceptibility gene that encodes the BRCA2- interacting protein. Mono-allelic mutations of PALB2 are associated with an increased risk for breast and ovarian cancer in women, prostate cancer in men, and pancreatic cancer in both gender. Women with no family history of breast cancer have a cumulative risk of 33%, compared to 58% in women with two or more family members with breast cancer. Several studies with populations ranging from to 54 to 362 individuals aimed to describe breast cancer phenotypic characteristics in PALB2 mutation carriers. Some of these studies suggested an association with triple-negative phenotype, older age at diagnosis (>30 years), tumor size > 2 cm, negative HER2 status, lymph nodes positive and bilaterality. Nevertheless, results among different studies are contradictory and no data on prognosis of these patients are reported. Furthermore, the clinical potential of PARP inhibition beyond currently approved indications to additional patients whose tumors have (epi)genetic changes affecting homologous recombination repair raises new interest in PALB2 mutations as molecular target. Primary objectives is to study the incidence and mortality rates of gPALB2 Breast Cancer.

NCT ID: NCT06402084 Recruiting - Clinical trials for The Relationship Between Fatty Liver and Breast Cancer

The Relationship Between Fatty Liver and Breast Cancer

Start date: May 2, 2024
Phase:
Study type: Observational

clinicopathological result of a common is (NAFLD) alcoholic fatty liver disease-nNo 30% of -NAFLD affects 20% .not caused by alcohol intake is chronic liver disease thatsuch as conditions spectrum of population and can be characterized by wide general et Chalasani( steatosis by isolated intracellular fat deposition marked noninflammatory .al., 2012) homeostasis and egulation of hepatic cholesterol NAFLD occurs due to the dysr . NAFLD is liver in triglycerides and free cholesterol, free fatty acids, accumulation ofabdominal and with insulin resistance, diabetes mellitus, metabolic syndrome associatedimplicated in the be can NAFLD that suggested reports the arge number ofL .obesity kidney diseases as well as cancersf cardiovascular, pulmonary, and pathology o .2015) et al., (Arguello their course of the Patients with breast cancer commonly develop NAFLD during .45.2%-2.3% approximately cancer is disease. The incidence of NAFLD in breast by influenced metabolic profile and is patient's NAFLD seems to be associated with cardiovascular and resistance insulin causingand treatment, breast cancer complications (Lee et al., 2017). modulators term estrogen inhibition with selective estrogen receptors-Long liver with tamoxifen fatty incidence of The s been reported to cause NAFLD.ha (SERMs)of NAFLD development in impact heT . use an that for aromatase inhibitoruse is higher th et al., (Yang breast cancer patients after hormonal treatment has not yet been elucidated .)6201 main and is aworldwide most common cancer in womenBreast cancer is the decreasing with has been cancer breast from ityortalM .women in death cancer of causeIt is well known time given the advances in screening strategies and adjuvant treatments. incidence of breast cancer is correlated with age and other risk factors such asthat the mutation, family history of )BRCA2( breast cancer gene2 or )BRCA1(gene1breast cancer al.,et Berry( and hormonal factors chest the to breast cancer, therapeutic radiation5).200 Breast cancer is divided according to the hormone receptors into either hormone receptor-positive tumors which are estrogen receptor-positive (ER-positive) and progesterone receptor-positive (PR-positive). These tumors express hormone receptors. This means they have a lot of hormone receptors. Hormone receptor-negative tumors are estrogen receptor-negative (ER-negative) and progesterone receptor-negative (PR-negative). These tumors donot express hormone receptors. This means they have few or no hormone receptors. About 70% to 80% of newly diagnosed breast cancers are hormone receptor- .al., 2017) (Wang et positive

NCT ID: NCT06401304 Recruiting - Breast Cancer Clinical Trials

Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)

OncoPROValue-1
Start date: January 1, 2020
Phase:
Study type: Observational

The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.

NCT ID: NCT06400849 Recruiting - Clinical trials for Non-metastatic Breast Cancer

Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy

ARIANE
Start date: April 4, 2024
Phase: N/A
Study type: Interventional

Breast cancer is the most frequently diagnosed cancer in the world. In France, 58,000 new cases were detected in 2018. Breast cancer is therefore the most common cancer in women. The 5-year survival rate for all stages combined is 88%. These excellent survival figures have been achieved thanks to improvements in treatment, including the advent of chemotherapy. The majority of patients will be cured of their cancer, so post-cancer quality of life is a major issue, hence the importance of trying to reduce long-term sequelae. Taxanes are one of the main cytotoxic anticancer agents used in the treatment of breast cancer. However, taxanes have a direct effect on the central and peripheral nervous systems and can induce chemotherapy-induced peripheral neuropathy (CIPN). The mechanisms of NPIC by taxanes are not fully understood. CINP is manifested by symptoms of paresthesia, numbness, burning, pain, altered temperature perception, myalgia, myopathy, fine motor difficulties, gait and balance disturbances, muscle weakness in the lower limbs and/or functional decline. NPIC occurs in 80 to 97% of patients treated with taxanes and is the main limiting toxicity during paclitaxel administration. NPIC often leads to postponement or reduction of dose, or even discontinuation of treatment. In addition, NPIC may last for several months or even years after the end of anti-cancer chemotherapy and represents the main long-term sequelae. This can promote and/or exacerbate symptoms of psychological distress (depressive symptoms and symptoms of anxiety) and lead to a reduction in quality of life (QoL). Prevention of NIPC is therefore a major issue in breast cancer treatment. According to the 2014 guidelines from the American Society of Clinical Oncology, prevention and treatment of IPN are inadequate with current weapons, and there is an urgent need to evaluate and find new methods of prevention. One of the challenges in the management of NIPC will be to reduce the pain induced without diminishing the anti-tumour effect of anti-cancer agents. In recent years, the effectiveness of cryotherapy using a frozen glove and compression therapy using surgical gloves (SG) in preventing taxane-induced PINC has been reported. During chemotherapy, patients wore a frozen glove on one hand and two surgical gloves of the same size on the other hand continuously. Recent study explained how compression therapy and cryotherapy shared a similar mechanism of reducing drug exposure due to vasoconstriction during paclitaxel infusion. The low temperature associated with cryotherapy would reduce paclitaxel uptake and peripheral nerve damage, or mechanotransduction, and allow a reduction in NIPC. To date, no study has investigated the efficacy of combining the two means of prevention. The current standard at the Centre Antoine Lacassagne is cryotherapy. The aim of this prospective, self-controlled trial is therefore to compare the efficacy of cryotherapy combined with compression prevention versus cryotherapy alone in preventing paclitaxel-induced peripheral neuropathy in patients undergoing adjuvant treatment for localised breast cancer.