Advanced searches left 3/3

Metastatic Triple-Negative Breast - ClinicalTrials.gov

Summarized by Plex Scholar
Last Updated: 06 May 2022

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

IRENE Study: Phase 2 Study of INCMGA00012 and the Oncolytic Virus Pelareorep in Metastatic Triple Negative Breast Cancer

In the second and third line setting, the objective of the combination of retininlimab and pelareorep for patients with metastatic triple negative breast cancer in the second and third line setting will determine the safety of the drug regiment. In the second and third line setting, researchers with metastatic triple negative breast cancer were unable to determine the safety, tolerability, and feasibility of INCMGA00012 in conjunction with the oncolytic virus pelareorep for patients with metastatic triple negative breast cancer. In patients receiving INCMGA00012 in conjunction with the oncolytic virus pelareorep for patients with metastatic triple negative breast cancer in the second and third line setting, the objective was to determine progression-free survival, overall survival, and duration of response. To determine whether pre-treatment PD-L1 expression is related to treatment outcomes. To determine whether T cell receptor expression changes as determined by T-cell receptor sequencing is predictive of treatment outcomes, it is easy to determine. On day 3, patients are still receiving retifanlimab IV over 60 minutes.

Source link: https://clinicaltrials.gov/ct2/show/NCT04445844


A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

As determined by an investigator response rate, the primary aim of this study for Phase 2 Cohort 2 is to determine the safety of magrolimab in combination with sacituzumab govitecan.

Source link: https://clinicaltrials.gov/ct2/show/NCT04958785


Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic Triple Negative Breast Cancer

CDX-301 raises the antigen presenting immune cells needed to jumpstart the immune response, while CDX-1140 stimulates these cells, and chemotherapy helps prepare these antigen presenting immune cells to recognize disease in the immune system in order to combat it. Patients with metastatic or unresectable triple negative breast cancer patients will be referred to this triplet mixture in preclinical studies as more effective than individual therapy or doublet combinations.

Source link: https://clinicaltrials.gov/ct2/show/NCT05029999


A Phase I/II Trial Evaluating the Safety and Efficacy of Eribulin in Combination With Copanlisib in Patients With Metastatic Triple Negative Breast Cancer

In metastatic triple negative breast cancer, the safety, toxicity profile, dose limiting toxicity, maximum tolerated dose, and a single dose of copanlisib hydrochloride were determining. In patients with metastatic TNBC treated with prior taxane and anthracycline, the comparison shows progression free survival between eribulin and eribulin plus copanlisib arms. To compare the ORR, CBR, PFS, PFS of eribulin and eribulin plus copanlisib arms in patients with tumors that lack a PIK3CA/PTEN pathway mutations, we'll compare the ORR, CBR, PFS, and PFS of eribulin and eribulin plus copanlisib arms in patients with tumors lacking PIK3CA/ PTEN pathway mutations In patients with tumors harboring PTEN expression by IHC in a pre-treatment metastatic site, it is possible to compare the ORR, CBR, PFS, PFS of eribulin and eribulin plus copanlisib arms in patients with tumors harbouring loss of PTEN expression by the IHC in pre-treatment metastatic site. PTEN IHC findings from a paired archival primary tumor biopsy versus baseline tumor biopsies can be compared to benchmark tumor biopsies. Comparing the ORR, CBR, PFS, PFS of eribulin and eribulin plus copanlisib arms in patients with tumor-based mutations in PIK3CA/PTEN by circulating tumor-derived deoxyribonucleic acid at baseline and potential changes over time. PTEN IHC results were compared between paired baseline tumor biopsy and disease progression in the first year. Determine circulating tumor DNA mutation profiles at baseline and shifts in mutation profile and variant allele frequencies on cycle 2 day 1 and at disease progression relative to baseline to correlate with treatment response. On days 1 and 8, patients are given eribulin intravenously over 2-5 minutes. GROUP I: Patients receive eribulin intravenously over 2-5 minutes. Patients are given copanlisib IV over 60 minutes and eribulin IV over 2 minutes on days 1 and 8, as well as days 1 and 15.

Source link: https://clinicaltrials.gov/ct2/show/NCT04345913


A Phase II Study Evaluating the Safety and Efficacy of Ivermectin in Combination With Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer

Using objective response rate, we determined the safety of ivermectin and pegolizumab in metastatic triple negative breast cancer in combination with peptin and pembrolizumab. Three doses of Adverse Events version 5. 0 to determine the safety and tolerability of ivermectin in combination with pembrolizumab. When given with petermectin, it is possible to determine the optimal biological dose of ivermectin. Patients' quality of life by the European Organization for Research and Treatment of Cancer The Quality of Life Questionnaire Core 30 measures patient quality of life. To investigate the change in peripheral blood immune profiles as a result of the combination therapy. Using a Nanostring Digital Spatial Profiler, it was possible to analyze the tumor immune profile and tumor microenvironment changes associated with the combination therapy. To investigate the relationship between gut microbiota and response to the combination therapy. On day 1, patients are also receiving pepericillinab intravenously over 30 minutes.

Source link: https://clinicaltrials.gov/ct2/show/NCT05318469


A Phase II Clinical Study of Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic Triple Negative Breast Cancer Patients Failed by Multiline Therapy

After partial ablation of the liver lesions, if the patient has no visible lesions outside of the liver, the measurable lesions should be retained. 1-3 days before beginning chemotherapy with tirelizumab + bevacizumab and post-inflammatory disease progression, blood samples were obtained for mutation load detection and immune function analysis.

Source link: https://clinicaltrials.gov/ct2/show/NCT05303038


A Phase IIb, Single Arm, Multicenter Trial of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments

These are a Phase IIb, single arm, multicenter study of sacituzumab govitecan in locally advanced or metastatic breast cancer patients who are refractory or relapsing after at least two prior standard chemotherapy regimens for unresectable, locally advanced, or metastatic breast cancer, and these regimens will qualify regardless of triple-negative status at the time. In all treated patients, the ORR per RECIST vs. 1. 1 by the Independent Review Committee would be the primary endpoint of the trial.

Source link: https://clinicaltrials.gov/ct2/show/NCT04454437


An Open-Label, Single-Arm Multicenter Phase 1b/2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Subjects With Metastatic Triple-Negative Breast Cancer (mTNBC)

In the metastatic setting, participants with eribulin mesylate in combination with pembrolizumab will be able to assess ORR in stratum 2 participants, as well as the historical response rate of pesylate in the metastatic setting.

Source link: https://clinicaltrials.gov/ct2/show/NCT02513472


A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE)

DAC inhibition in breast cancer cell lines, including triple-negative cell lines, has been shown to inhibit cell cycle progression, including CDKN1A, CDKN1C, CDKN2B, and CDKN2D. [10] Others have observed cell cycle arrest by DAC inhibitors as a result of increases in p21 or decreases in cyclin A and cyclin A. [11-13] We also see an increase in RB1 expression in breast cancer cell lines, as shown by the image above. [11-13] We also see an increase in RB1 expression in breast cancer cell lines. RB1 was regularly down-regulated in triple-negative breast cancer, but not mutated or lost in the TCGA breast cancer study. [14] We also expected that DAC inhibition would raise the sensitivity of breast cancer to CDK4/6 inhibition. [10] Since then, we've tried the combination of the DAC inhibitor vorinostat and the CDK4/6 inhibitor PD-322991 in a larger panel of cell lines and have demonstrated at least additivity in those triple-negative cell lines. A dramatic decline in Ki-67 in three-negative breast cancers was seen with just one week of valproic acid, proving the principle biologic activity of DAC inhibition in triple-negative breast cancer. Given the genetic similarities between serous ovarian cancer and triple-negative breast cancer seen in the TCGA and pan-cancer studies [16], we have chosen to include ovarian cancers in the dose-escalation component to raise accrual rate but not in the dose-expansion. Neither CDK4/6 inhibition nor DAC inhibition have a well-defined predictive biomarker to determine which cancers will respond and which will not.

Source link: https://clinicaltrials.gov/ct2/show/NCT04315233


A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC)

Participants in Stage 1 of the 2L CIT-naive cohort that experience disease progression, loss of medical assistance, or unacceptable toxicity during Stage 1 may be eligible to receive hospitalization with a new treatment regimen, provided Stage 2 is open for enrollment.

Source link: https://clinicaltrials.gov/ct2/show/NCT03424005

* 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