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Breast Neoplasms clinical trials

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NCT ID: NCT05469750 Not yet recruiting - Clinical trials for Advanced Breast Cancer

Dalpiciclib Plus Letrozole and Capecitabine

Start date: August 10, 2022
Phase: Phase 2
Study type: Interventional

to assess the effect of dalpiciclib plus letrozole and capecitabine of first-line treatment with breast cancer

NCT ID: NCT05468710 Not yet recruiting - Breast Cancer Clinical Trials

Inflammatory Blood Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Start date: September 2022
Phase:
Study type: Observational

Breast cancer is the most threatening disease in women. Neoadjuvant chemotherapy is a commonly used for the treatment. Inflammation plays an important role in tumor proliferation, metastasis, and resistance to chemotherapy. Inflammatory blood markers (IBM) reflect the balance between host inflammatory and immune status. Different IBM have been reported as prognostic factors for survival and predictive factors for pathological complete response and toxicity. Our aim to evaluate these IBM in breast cancer patients receiving neoadjuvant chemotherapy.

NCT ID: NCT05468034 Recruiting - Breast Cancer Clinical Trials

Exercise in Metastatic Breast Cancer: EMBody

Start date: April 26, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to study exercise in a novel population with indolent MBC (no progression on current therapy in prior 12 months and not receiving cytotoxic chemotherapy). The study team hypothesizes that delivering virtual, supervised, progressive intensity aerobic and resistance training exercise for 16 weeks in this population will significantly improve 1) cardiorespiratory fitness, functional status, and sarcopenia (low muscle mass), all established predictors of survival, and 2) patient- reported outcomes.

NCT ID: NCT05467891 Recruiting - Clinical trials for HER2-negative Breast Cancer

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

RaPhLRR
Start date: September 13, 2022
Phase: Phase 2
Study type: Interventional

This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

NCT ID: NCT05467111 Recruiting - Clinical trials for Early-stage Breast Cancer

Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

CardioProtEx
Start date: January 23, 2023
Phase: N/A
Study type: Interventional

Cardiotoxicity is one of the most significant adverse effects in breast cancer patients treated with anthracyclines (a type of chemotherapy), so we propose to determine whether acute training (i.e., 24h before each chemotherapy session) could reduce the levels of a cardiac biomarker which measures muscle damage (NT-proBNP). Given the fact NT-proBNP attenuation has been observed with one session performed 24h before the first treatment, we propose to verify these findings in each cycle of doxorubicin analyzing how each type of exercise (aerobic, strength or combined aerobic + strength) may impact on anthracycline-induced cardiotoxicity, since this observation may be relevant considering the feasibility and low cost this implementation would represent in clinical practice.

NCT ID: NCT05466786 Not yet recruiting - Breast Cancer Clinical Trials

Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer

Start date: July 15, 2022
Phase:
Study type: Observational

This was a cross-sectional and an observational study, investigator-initiated study in HER2-low breast cancer patients. Approximately 335 subjects will be enrolled in this study to examine the distribution and features of HRD (Homologous recombination deficiency)/HRR (Homologous recombination repair). In this study, investigators plan to clarify the frequency of HRR/HRD in Chinese patients with her2-low breast cancer. In addition, it is planned to investigate any association between invasive disease-free survival (IDFS) / overall survival (OS) and HRD/HRR in her2-low Breast cancer patients.

NCT ID: NCT05466760 Recruiting - Breast Cancer Clinical Trials

PET/MR Radiomics for Breast Cancer Diagnosis

Start date: July 6, 2018
Phase:
Study type: Observational [Patient Registry]

Breast cancer is the most common malignancy in women in our country (2013 cancer registry report, Health Promotion Administration). MRI is a more accurate imaging modality for breast lesion diagnosis, monitoring of treatment response, and local staging than compared with mammography and ultrasound. ¹⁸ F-FDG PET was reported to be used for breast cancer diagnosis, staging, and prediction of treatment response as well. We usually interpret the aforementioned imaging modalities by qualitative methods for decision-making. Radiomics is a process involving the conversion of images to quantitative data for subsequent data mining to improve decisional making for patient care, to adjust the patient management, that is so-called precision medicine. Our study is to use semantic and agnostic features of radiomics by hybrid PET/MR for 1. The pre-operative breast cancer patients (without neoadjuvant chemotherapy before operation). 2. The patients will receive neoadjuvant chemotherapy (NAC). The study intends to investigate the association of PET/MR radiomics data with the probability of metastasis or risk of recurrences and survival. We will also investigate if the BD and BPE (measured on MRI) are associated with molecular subtypes, histologic grade and clinical outcome, risk of metastases, and long-term survival of breast cancer patients for the study participants.

NCT ID: NCT05465408 Recruiting - Breast Cancer Clinical Trials

Culturally Aware AET Non-Initiation Intervention

Start date: July 21, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the feasibility and acceptability of a brief, nurse-led intervention to support breast cancer survivors who have delayed initiation of hormonal therapy or who have concerns about starting hormonal therapy.

NCT ID: NCT05465031 Not yet recruiting - Breast Cancer Clinical Trials

Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM)

Start date: February 2023
Phase: Phase 4
Study type: Interventional

Breast cancer is the most commonly cancer in women in the overall global population. According to the World Cancer Research Fund International, there were more than 2.25 million new cases of breast cancer in women in 2020. Although the modern treatment strategies, based on the complex care, which consists of surgery, radiotherapy, hormone therapy, and targeted chemotherapy directed at specific cancer molecules have substantially reduced the risk of death due to breast cancer, their wide adoption results in the wider prevalence of cardiotoxicity, defined as either symptomatic heart failure, or asymptomatic contractile dysfunction. The occurrence of cardiotoxicity induced by anti-cancer therapies is estimated at 5-15%, and its development is the primary cause of therapy termination, which significantly reduces the probability of the efficacy of treatment. Several attempts have been made to determine the efficacious preventive strategy, which could diminish the risk of cancer-therapy induced cardiotoxicity. The results of the prior studies indicated a trend towards lower risk of troponin elevation, or left ventricular contractile dysfunction with the introduction of drugs interfering with the renin-angiotensin-aldosterone (RAA) axis, which constitute the primary treatment modality in heart failure with reduced ejection fraction (HFrEF). Sacubitril/valsartan, the novel therapeutic agent, has been demonstrated to significantly improve prognosis in patients with HFrEF. Prior retrospective, small, single-center studies have shown that treatment with sacubitril/valsartan may reduce the risk of cancer-therapy induced cardiotoxicity, or reverse contractile dysfunction caused by anti-cancer therapy. However, no large randomized data confirmed these findings. Therefore, the Sacubitril/Valsartan in PriMAry preventIoN of the cardiotoxicity of systematic breaST canceR trEAtMent) study, has been designed to verify, whether the preventive use of sacubitril/valsartan administered in the doses recommended in patients with HFrEF in breast cancer patients undergoing adjuvant chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will reduce the incidence of cardiotoxicity defined as impaired left ventricular systolic function on cardiac magnetic resonance imaging (MRI). In the trial, a total of 480 patients with histologically confirmed breast cancer, who are eligible for chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will undergo 1:1 randomization to either preventive treatment with sacubitril/valsartan or placebo. The patients will be followed for 24 months, and will have repetitive efficacy and safety examinations, including echocardiography, MRI, electrocardiography including 24-h Holter monitoring, blood tests, functional capacity tests and quality of life assessment.

NCT ID: NCT05464810 Recruiting - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer

Start date: September 2, 2022
Phase: Early Phase 1
Study type: Interventional

This early phase I trial tests whether letrozole with simvastatin works better than letrozole alone to stop tumor cell proliferation in patients with stage I-III hormone receptor positive, HER2 negative invasive breast cancer. Letrozole and simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The addition of simvastatin to letrozole may be more effective at stopping the growth of cancer cells than letrozole alone.