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Metastatic Breast Cancer - ClinicalTrials.gov

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Last Updated: 23 June 2022

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

Evaluate the results of fludeoxyglucose F-18 -positron emission tomography (computed tomography response criteria as a binary predictor of progression-free survival in patients with bone-dominant metastatic breast cancer treated with systemic therapy. Evaluate the ability of FDG-PET/CT modified PERCIST guidelines to reliably predict PFS in patients with BD MBC. Evaluate the ability of FDG-PET/CT updated PERCIST indicators to forecast time to skeletal-related events and overall survival in patients with BD MBC. Patients with BD MBC should have their PFS, time to SRE, and OS with the help of FDG-PET/CT metrics to forecast PFS, time to SRE, and OS. Determine the ability of FDG-PET/CT to detect disease progression by the detection of new lesions that are not visible by routine CT and bone scans. OUTLINE: Patients receive FDG intravenously and a PET/CT scan over 15-30 minutes at baseline and more than 12 weeks after starting standard systemic therapy in the absence of unacceptable toxic effects.

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

By examining progression free survival, we can determine the safety of Y90 radioembolization as a 2nd or 3rd line therapeutic option in conjunction with systemic therapy. To determine the effectiveness of Y90 radioembolization as a 2nd or 3rd line therapeutic option in conjunction with systemic therapy by investigating treatment-related adverse effects and identifying baseline predictors of treatment-related toxicity. On PFS and toxicity, triple negative breast cancer versus non-TNBC on PFS and toxicity. In patients receiving Y90 versus others, it is possible to determine the quality of life changes in patients receiving Y90. To determine the benefits of adding Y90 radioembolization to systemic therapy, please use this study. Hepatobiliary iminodiacetic acid scan as a way to objectively measure baseline and post-treatment hepatic dysfunction. Patients underwent Y90 radioembolization, beginning 1-6 weeks after starting 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

Compared to paclitaxel alone, the combination of radium Ra 223 dichloride and paclitaxel increases progression-free survival. To find the time to the first symptomatic skeletal event, a symptomatic skeletal condition is used. With paclitaxel, it's easy to determine the stability of radium-223 dichloride. Studies can determine if molecular changes in deoxyribonucleic acid repair genes are related to derogation of radium-223 dichloride and. Investigate if heterozygosity in triple negative tumors is related to the response to radium-223 dichloride. To contribute genetic analysis results from de-identified biospecimens to Genomic Data Commons, a well-organized cancer molecular and clinical data repository, for current and future research; specimens will be annotated with key clinical information, including diagnosis, staging, and, in the event, outcome, as well as the patient's. To response to radium-223 dichloride therapy, to correlate change in the amount of total alkaline phosphatase, bone-specific alkaline phosphatase, and serum osteocalcin. In each bone metastatic lesions as well as elsewhere in the body, including vital organs that use dosimetry, the radium-223 dichloride bio-distribution and absorption dose was investigated. Patients are treated paclitaxel intravenously over 1 hour on days 1, 8, 15, 15 and 15, as well as radium Ra 223 dichloride IV over a minute on day 1. In the absence of disease progression or unacceptable toxicity, treatment with radium Ra223 dichloride repeats every 28 days for 6 cycles, and treatment with paclitaxel repeats every 28 days. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.

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


Phase I Trial of Low-Dose Cyclophosphamide in Combination With Veliparib (ABT-888) in HER2/Neu-Negative Metastatic Breast Cancer

To determine the optimum phase II dose of veliparib that can be combined with metronomic dose cyclophosphamide in patients with metastatic breast cancer, patients with metastatic breast cancer must be enrolled. To determine whether the macroH2A1. 1 and polymerase 1 expression status in archived paraffin embedded tumor specimens from either primary tumor or metastatic disease are predictive of clinical benefit with veliparibplus cyclophosphamide, it is helpful to determine if clinical benefit with veloparibplus cyclophosphamide.

Source link: https://clinicaltrials.gov/ct2/show/NCT01351909


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

To determine the negative predictive value of [18F]fluoroestradiol uptake in patients with estrogen-receptor positive metastatic breast cancer treated with first-line endocrine therapy, patients with estrogen-receptor positive metastatic breast cancer treated with first-line endocrine therapy, sees. To determine the ability of FES-PET/CT for predicting response in patients treated with first-line endocrine therapy for metastatic breast cancer, patients were treated with first-line endocrine therapy. To predict progression-free survival to first line endocrine therapy for metastatic breast cancer, first line endocrine therapy for metastatic breast cancer is the most optimum cutpoint for predicting progression-free survival to first line endocrine therapy for metastatic breast cancer. FES uptake in individual patients is assessed as variation in lesion's FES uptake. To determine the heterogeneity of tumor FES uptake in individual patients, which is similar to variability in lesion's FES uptake. OUTLINE: Patients receive F-18 16 alpha-fluoroestradiol intravenously over 2 minutes and perform PET/CT from 0 to 30 days before start of endocrine therapy, according to the OUTLINE. Patients can do a second FES-PET/CT study at least 24 hours after the first study was published and no later than ten days after the initial analysis was published.

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


Comparative Effects of Ribociclib and Palbociclib on Circulating and Tumor Infiltrating Myeloid Cells in Metastatic Breast Cancer Patients

In advanced, hormone receptor positive breast cancer patients, it's critical immunobiostaters and mechanisms of response to ribociclib or palbociclib. Describe developed immune tumor microenvironment characteristics of resistance in patients that are undergoing ribociclib or palbociclib therapy. PROTECTIVE COHORT: Patients receive a standard of care treatment consisting of ribociclib or palbociclib plus an aromatase inhibitor. On day 1 of SOC treatment cycles 2, 4, and 6, every 6 cycles thereafter, and at post-treatment, patients also obtain blood samples at baseline, every 6 cycles thereafter, as well as at post-treatment. Patients' tumor tissue collected during previous SOC therapy is used for analysis.

Source link: https://clinicaltrials.gov/ct2/show/NCT05244434


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

To find out if the addition of a placebo to a regimen of pertuzumab and trastuzumab combined with a taxane in patients with newly established measurable metastatic breast cancer, the investigator using Response Evaluation Criteria in Solid Tumors 1. 1 criteria will determine if the addition of atezolizumab and trastuzumab is likely to increase the progression-free survival. To determine if adding atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane will raise the overall objective response, according to an investigator using RECIST 1. 1 criteria relative to the introduction of placebo to a regimen of pertuzumab and trastuzumab as a component of a taxane regimen. To reduce the risk of subsequent brain metastases in patients without known brain metastases at study entry relative to the introduction of placebo to a regimen of perceptuzumab and trastuzumab mixed with a taxane, the addition of atezolizumab to a mix of pertuzumab and trastuzumab will reduce the risk of future brain metastases in patients with no apparent brain metastases at study entry relative to the introduction of pertuzumab and ab and trastuzumab and trastuzumab and trastuab and ab and trastuzumab and trastuzumab and trastuzumab and ab and ab and taxane ab and taxane ab and trastuzumab and trastuzumab and trastuzumab and trastuzumab and trastuzumab and trastuzumab and trastuzumab and trastuzumab and trastuzumab and tras To determine if the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane can lead to increased patient-reported exhaustion in comparison to the addition of placebo to a regimen of pertuzumab and trastuzumab combined with a taxane is to blame. To identify potential biomarkers that can predict the success of atezolizumab in patients with newly confirmed HER2-positive measurable metastatic breast cancer treated with a regimen of pertuzumab and trastuzumab accompanied by a taxane regimen.

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

At 12 weeks, we will be able to determine differences in symptoms among participants treated witheribulin mesylate and standard weekly paclitaxel at 12 weeks, which will be able to demonstrate that patient-reported Patient-Report Outcomes Version of the Common Terminology Criteria for Adverse Events data will be able to show significant differences in symptoms between participants treated with eribulin mesylate and standard weekly paclitaxel. Patients receiving eribulin versus standard weekly paclitaxel is compared to standard weekly paclitaxel's overall survival, progression-free survival, objective response time, and time to treatment failure. Compare the 12 month rate of disease progression in patients receiving eribulin versus standard weekly paclitaxel. In patients receiving eribulin compared to the common weekly paclitaxel, it is important to determine the toxicities in patients receiving eribulin. In patients receiving eribulin or standard weekly paclitaxel, a new metastasis free survival in patients receiving eribulin is compared to standard weekly paclitaxel. To investigate the connection 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 of M30 neo-epitope as potential biomarkers for clinical benefit from therapy with eribulin specifically or as general microtubule dynamics inhibitors. As potential biomarkers associated with clinical benefit from therapy with eribulin specifically or general microtubule dynamics inhibitors, it is possible to determine tubulin isotype expression, mutations, and signaling pathway changes in tumor tissue. ARM A: On days 1, and 8, patients are given eribulin mesylate intravenously for about two minutes. ARM B: Patients receive paclitaxel IV more than 1 hour on days 1, 8, and 15.

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


A Phase II Study of Pembrolizumab and Eribulin in Patients With HR-positive/HER2-negative Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

This is a multicenter, open-label, phase II clinical trial that seeks to determine the safety of peribolizumab in female patients older than 18 years old with hormone receptor-positive/HER2-negative metastatic breast cancer previously treated with at least one, but not more than two, prior chemotherapeutic regimens for local recurrent and/or metastatic disease. For this research, available tumor tissue for PD-L1 biomarker analysis from a newly obtained core or excisional biopsy since the last progression of a metastatic tumor lesion that has not been previously treated is required. Investments Meu00300diques" is a leading laboratory that will be used to identify dynamic biomarkers that might be predictive of response to MK3475 and eribulin therapy.

Source link: https://clinicaltrials.gov/ct2/show/NCT03222856


A Phase II Prospective Trial Correlating Progression Free Survival With CYP2D6 Activity in Patients With Metastatic Breast Cancer Treated With Single Agent Tamoxifen

Primary Objectives: Primary To determine the correlation between CYP2D6 score and progression-free survival of patients with metastatic breast cancer treated with tamoxifen citrate. Secondary To summarize the CYP2D6 score and PFS of patients treated with this therapy, correlate. To determine CYP2D6 status and the number of these patients who are PFS at 6 months, we'll use a CYP2D6 report to determine CYP2D6 score and the number of those patients who are PFS at 6 months. PFS determines the presence of candidate estrogen receptor 1 and 2 variant alleles, UGT7, SULT1A1, and other candidate genes. On days 1-28, patients are treated with oral tamoxifen citrate once a day.

Source link: https://clinicaltrials.gov/ct2/show/NCT01124695

* 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