Advanced searches left 3/3

Metastatic Breast Cancer - ClinicalTrials.gov

Summarized by Plex Scholar
Last Updated: 23 April 2022

* If you want to update the article please login/register

Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer

Despite major advances in recent decades in early stage breast cancer treatment, which resulted in an 89% 5-year survival rate, metastatic breast cancer is still considered incurable due to a lack of most common treatments. As such, the 5-year survival rate for metastatic breast cancer is only 22%. Their vascular system is compromised, contributing to decreased delivery of systemic therapy and oxygen, which is one explanation for resistance to cancer drugs and metastasis in solid tumors. Short periods of fasting or caloric restriction may also be safe and effective ways to reduce tumor formation and enhance chemotherapy sensitivity, as well as providing anti-chemotherapy in healthy cells. Patients will be randomly assigned to an acute intervention consisting of either caloric restriction administered acutely prior to and aerobic exercise during each of six chemotherapy cycles, or usual care. The participants will include adults with metastatic breast cancer with measurable metastases who will receive intravenous chemotherapy. The aerobic exercise program will consist of a single controlled recumbent cycle ergometer session that will take place simultaneously with each chemotherapy infusion. Tumor outcomes will be determined by CT scan and MRI, while treatment side effects will be determined by MRI and treatment quality of life will be determined by questionnaire before, during and after up to six chemotherapy cycles of a common treatment regimen.

Source link: https://clinicaltrials.gov/ct2/show/NCT03795493


FDG PET to Assess Therapeutic Response in Patients With Bone-Dominant Metastatic Breast Cancer, FEATURE

Evaluate the efficacy of fludeoxyglucose F-18-positron emission tomography response parameters as a binary predictor of progression-free survival in patients with bone-dominant metastatic breast cancer treated with systemic therapy. The ability of FDG-PET/CT updated PERCIST measures to accurately predict PFS in patients with BD MBC is determined by evaluation. Evaluate the ability of FDG-PET/CT modified PERCIST guidelines to forecast time to skeletal related events and overall survival in patients with BD MBC. In patients with BD MBC, patients with FDG-PET/CT metrics can be used to estimate PFS, time to SRE, and OS. Evaluate the use of FDG-PET/CT to monitor disease progression by the detection of new lesions that are not visible by standard CT and bone scan. In collaboration with the National Cancer Institute Quantitative Imaging Network, researchers from the University of Glasgow investigate new ways for determining metabolic response with FDG-PET/CT to estimate clinical endpoints in patients with BD MBC.

Source link: https://clinicaltrials.gov/ct2/show/NCT04316117


Safety and Efficacy of Radioembolization of Metastatic Breast Cancer to the Liver as a 2nd/3rd Line Therapy

The ability of Y90 radioembolization as a 2nd or 3rd line therapeutic option in conjunction with systemic therapy can be determined by determining progression-free survival. To determine the efficacy of Y90 radioembolization as a 2nd or 3rd line therapeutic approach in conjunction with systemic therapy by identifying baseline predictors of treatment-related toxicity and determining baseline predictors of treatment-related toxicity. In patients receiving Y90 versus others, we can determine the quality of life changes. To determine the survival benefit of adding Y90 radioembolization to systemic therapy, we'll need to determine the likelihood of conversion. To determine potential synergistic immunotherapy pathways, we used the V. to compare inflammatory changes in the targeted tumors before and after Y90 radioembolization for determining potential synergistic immunotherapy pathways. To find genetic biomarkers of treatment reaction to Y90 radioembolization, it's important to identify genetic biomarkers of disease response. Hepatic dysfunction is measured with objectively by baseline and post-treatment hepatic dysfunction. ARM I: Patients receive systemic therapy.

Source link: https://clinicaltrials.gov/ct2/show/NCT05315687


Phase II Trial of Radium-223 Dichloride in Combination With Paclitaxel in Patients With Bone Metastatic Breast Cancer

When compared to paclitaxel alone, the combination of radium Ra 223 dichloride and paclitaxel improves progression-free survival. The purpose of determining the safety of radium-223 dichloride with paclitaxel was determined. Investigate if molecular changes in deoxyribonucleic acid repair genes are related to the response to radium-223 dichloride and. Investigate if heterozygosity in triple negative tumors is related to the occurrence of radium-223 dichloride. To submit genetic analysis data from de-identified biospecimens to Genomic Data Commons, a well-known cancer molecular and clinical data repository, for current and future study; specimens will be annotated with key clinical data, including diagnosis, staging, and analysis, with possible outcomes; if possible, outcomes. To response to radium-223 dichloride therapy, the changes in total alkaline phosphatase, bone-specific alkaline phosphatase, and serum osteocalcin were correlated. IV. Each bone metastatic lesions and elsewhere in the body, including critical organs using dosimetry, were investigated by radium-223 dichloride bio-distribution and absorption dose. Patients are treated paclitaxel intravenously over 1 hour on days 1, 8, 15, and 15, with a radium Ra 223 dichloride IV over 1 minute on day 1. In the absence of disease progression or unacceptable toxicity, asymptomatic toxicity with radium Ra 223 dichloride repeats every 28 days for six cycles, and prescription with paclitaxel repeats every 28 days. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Patients are followed up at 30 days and then every 3 months for two years after completion of study study.

Source link: https://clinicaltrials.gov/ct2/show/NCT04090398


Phase Ib Study of Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Patients With Metastatic Breast Cancer

Ablation of the presence or activity of the TMEM-associated macrophages blocks intravasation at TMEM, demonstrating an essential role for perivascular macrophages in TMEM function. We hypothesize that rebastinib combined with antitubulin therapy may have a dramatic effect in breast cancer by preventing intravasation at TMEM centers and preventing further metastasis.

Source link: https://clinicaltrials.gov/ct2/show/NCT02824575


A Phase II Single Arm Trial of Adding Simvastatin to Dual Anti-HER2 Therapy in Patients With HER2-Positive Metastatic Breast Cancer

This research is looking for participants with metastatic breast cancer that is HER2 positive. A cancer cell has too many HER2 receptors on its surface, which leads to a "HER2 positive" status. HER2 receptors behave like copy machines and encourage cancer cells to grow and multiply. Her2-targeted drugs function by blocking the HER2 protein from causing the cell to grow and divide. Once the protein stops functioning, the cancer cells can no longer make copies of themselves. Once a cancer cell is unable to produce copies of itself, the tumor will begin to shrink. According to the researchers, adding simvastatin to an anti-HER2-therapy regimen may cause the cancer to start responding again to your HER2-medications. According to laboratory studies, simvastatin combined with dual HER2-targeted therapy slows breast cancer tumor formation that had been increasing on single HER2-targeting therapy alone.

Source link: https://clinicaltrials.gov/ct2/show/NCT03324425


[18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients With Newly Diagnosed Metastatic Breast Cancer

[18F]fluoroestradiol uptake for response at 6 months in patients with estrogen-receptor positive metastatic breast cancer treated with first-line endocrine therapy helped determine the negative predictive value of [18F]fluoroestradiol uptake for response at 6 months. To determine the accuracy of FES-PET/CT in predicting reaction in patients treated with first-line endocrine therapy for metastatic breast cancer patients. To determine the reliability of FES-PET/CT for predicting progression-free survival in patients treated with first-line endocrine therapy for metastatic breast cancer patients, see Table. To determine progression-free survival to first-line endocrine therapy for metastatic breast cancer, you should use FES SUVmax 1. 5 as the highest cutpoint for predicting progression-free survival. OUTLINE: Patients receive F-18 16 alpha-fluoroestradiol intravenously over 2 minutes and do PET/CT from 0 to 30 days before starting endocrine therapy. Patients may be enrolled in a second FES-PET/CT study at least 24 hours after the first one was published and no later than ten days after the initial research was published.

Source link: https://clinicaltrials.gov/ct2/show/NCT02398773


Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapywhich Patients Will Benefit From Surgery

The results of the primary and metastatic lesions following first-line systemic therapy in patients with newly diagnosed breast cancer patients were analyzed and summarized by this report, which then inferred the time of surgical intervention. The investigators investigated the following A, B, and C scenarios in order to determine the tumour heterogeneity between the primary and metastatic tumors. The results of primary and metastatic lesions were mainly divided into four groups following systemic therapy in patients with de novo metastatic breast cancer. Therefore, only a proactive assessment and timely intervention will determine the time window for tumor therapy. The time frame for surgical treatment is crucial because, once missed, the tumor will continue with new metastatic lesions. Figure 1-b: The imaging study shows complete remission of the metastatic tumor with persistent primary tumors. Patients with early resectable breast cancer may have similar problems in this situation.

Source link: https://clinicaltrials.gov/ct2/show/NCT05285332


A Randomized, Double-Blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab With Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

When combining atezolizumab and trastuzumab with a taxane regimen, the survival rate relative to placebo's introduction of placebo to a regimen of pertuzumab and trastuzumab can be improved. To determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane would boost the overall objective response, according to an investigator using RECIST 1. 1 criteria relative to the addition of placebo to a regimen of perfuzumab and trastuzumab mixed with a taxane. To determine whether adding atezolizumab to a regimen of perceptive brain metastases in patients without established brain metastases at study entry relative to the introduction of placebo to a regimen of perceptuzumab and trastuzumab mixed with a taxane is likely to reduce the incidence of subsequent brain metastases in patients without a history of cerebral metastases. To find out if the addition of atezolizumab and trastuzumab to a combination of permuzumab and trastuzumab mixed with a taxane may have contributed to increased patient-reported exhaustion in comparison to the addition of placebo to a regimen of pertuzumab and trastuzumab combined with a taxane regimen combined with a taxane. To find potential biomarkers that can predict the benefits of atezolizumab therapy in patients with newly diagnosed HER2-positive measurable metastatic breast cancer treated with a combination of pertuzumab and trastuzumab as well as a taxane regimen. On day 22 of cycle 1 and days 1 and 22 of subsequent cycles, patients also received atezolizumab IV over 30 minutes.

Source link: https://clinicaltrials.gov/ct2/show/NCT03199885


A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Patients treated with eribulin mesylate and standard weekly paclitaxel at 12 weeks, to demonstrate that patient-reported Patient-Report Outcomes Version of the Common Terminology Criteria for Adverse Events will be able to identify differences in symptoms among participants treated witheribulin mesylate and standard weekly paclitaxel at 12 weeks. To predict peripheral neuropathy in EPHA5 using a microtubule targeting agent, we'll use rs7349683 as a predictor of peripheral neuropathy. In patients receiving eribulin versus standard weekly paclitaxel, the 12 month rate of disease progression in patients receiving eribulin is compared to standard weekly paclitaxel. Patient-reported symptom toxicity data can be used to determine the clinical relevance and reliability of gathering patient-reported symptom toxicity data by the Patient-Report Outcomes Version of the Common Terminology Criteria for Adverse Events. To determine the toxicity in patients receiving eribulin versus conventional weekly paclitaxel, we need to determine the difference. In patients receiving eribulin compared to the usual weekly paclitaxel, we'll compare new metastasis-free survival in patients receiving eribulin. To investigate the association between common single nucleotide polymorphisms in FGD4, FZD3, and VAC14 as predictors of peripheral neuropathy after treatment with a microtubule targeting agent. To determine whether circulating nucleosomes and the apoptosis associated with M30 neo-epitope as potential biomarkers of clinical benefit from treatment with eribulin specifically or microtubule dynamics inhibitors in general, we investigated circulating nucleosomes and the apoptosis associated with clinical benefit from treatment with eribulin specifically or microtubule dynamics inhibitors in general. As potential biomarkers associated with clinical benefit from therapy with eribulin specifically or general microtubule dynamics inhibitors, it is possible to investigate tubulin isotype, mutations, and signal pathway changes in tumor tissue. ARM A: On days 1, and 8, patients are given eribulin mesylate intravenously for over 2 minutes. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.

Source link: https://clinicaltrials.gov/ct2/show/NCT02037529

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions