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Triple Negative Breast Cancer clinical trials

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NCT ID: NCT05134194 Terminated - Clinical trials for Triple Negative Breast Cancer

A Study of Camrelizumab in Combination With Chemotherapy Regimen Comparative Chemotherapy Regimen for Metastatic Triple-negative Breast Cancer

Start date: January 17, 2022
Phase: Phase 3
Study type: Interventional

Approximately 104 subjects with recurrent or metastatic IM triple negative breast cancer were planned to be included in the study, and screened eligible subjects were randomly assigned in a 1:1 ratio to treatment with the combination of Camrelizumab and investigator's choice of chemotherapy (test arm), treatment with investigator's choice of chemotherapy (control arm), and the stratification factor was liver metastasis (with vs without). After enrollment, subjects in the test group were treated with Camrelizumab 200 mg IV every 3 weeks for one cycle. The investigator's choice of single agent chemotherapy regimen (capecitabine, eribulin, gemcitabine, or vinorelbine) was every 3 weeks for one cycle until disease progression, intolerable toxicity, withdrawal of informed consent, or discontinuation at the investigator's discretion.

NCT ID: NCT05115474 Recruiting - Clinical trials for Triple Negative Breast Cancer

Study of Screening Brain MRIs in Stage IV Breast Cancer

Start date: December 21, 2021
Phase:
Study type: Observational

The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.

NCT ID: NCT05113966 Active, not recruiting - Clinical trials for Triple Negative Breast Cancer

Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

Start date: November 22, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label, single arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatments, at least 1 in the metastatic setting.

NCT ID: NCT05112536 Completed - Breast Cancer Clinical Trials

Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer

Start date: March 3, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the mechanism of action, as well as the safety and efficacy of trilaciclib in combination with standard of care treatment in the neoadjuvant setting of early-stage triple negative breast cancer (TNBC). This study will have four phases: 1) Screening Phase, 2) Trilaciclib Lead-In Phase, 3) Treatment Phase, and 4) Surgery and Follow-Up Phase. After a screening phase of up to 21 day, each participant will receive trilaciclib single-dose monotherapy during the lead-in phase, followed by a tumor biopsy. During the treatment phase, each participant will receive trilaciclib with standard of care chemotherapy. Immunotherapy may be included during the treatment phase, per standard of care. 3-5 weeks following conclusion of the treatment phase, each participant will undergo definitive surgery. A 30-day Safety Follow-up Visit will occur 30 days after the last dose of trilaciclib and an End of Study Visit will occur within 14 days after definitive surgery.

NCT ID: NCT05111067 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

Molecular Subtyping of Triple-negative Breast Cancer and African Ancestry-related Immunogenicity

Start date: December 2021
Phase:
Study type: Observational

Triple-negative breast cancer (TNBC) is a heterogeneous disease that is associated with a younger age of onset, worse stage matched-outcomes, and women of African ancestry in North America. A higher incidence of TNBC is also seen in West Africa, despite unique environmental, socioeconomic and modifiable risk factors. Transcriptome analysis of TNBC has delineated four distinct subgroups with therapeutic and prognostic significance. With further characterization, important regional differences have emerged between populations of African vs. European ancestry. These differences may have significant implications for the efficacy of novel TNBC-targeted therapy and need to be further evaluated. Transcriptional data on TNBC in sub-Saharan African also offers the opportunity to evaluate the relationship between breast cancer phenotype and ancestry-linked differences in the tumor-immune microenvironment.

NCT ID: NCT05103917 Enrolling by invitation - Clinical trials for Triple Negative Breast Cancer

A Study to Assess the Safety, Tolerability and Antitumor Activity of X4P-001 in Combination With TNBC

Start date: July 21, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Objectives Phase 1b Primary Objectives: To evaluate the safety and tolerability of X4P-001 combined with toriplimab in patients with locally advanced or metastatic TNBC Secondary Objectives: 1. To characterize the pharmacokinetics (PK) profile of X4P-001 alone or combined with toriplimab 2. To characterize the antitumor activity of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC(according to RECIST 1.1) 3. To characterize the overall survival of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC 4. To characterize the immunogenicity of toriplimab when administrated in combination with X4P-001

NCT ID: NCT05099978 Recruiting - Ovarian Cancer Clinical Trials

Asian Multicenter Prospective Study of ctDNA Sequencing

A-TRAIN
Start date: November 1, 2021
Phase:
Study type: Observational

This study is a genetic analysis of aberrations in circulating tumor DNA (ctDNA) in patients in Asian countries. This study protocol is divided into parts describing several subanalyses that differ in terms of cancer types, analytical methods, participating countries, and participating institutions.

NCT ID: NCT05086692 Recruiting - Ovarian Cancer Clinical Trials

A Beta-only IL-2 ImmunoTherapY Study

ABILITY-1
Start date: August 27, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.

NCT ID: NCT05082610 Recruiting - Cancer Clinical Trials

A Study of HMBD-002, a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab

Start date: January 1, 2022
Phase: Phase 1
Study type: Interventional

This is a phase 1/2, open-label, multi-center, first-in-human, two-stage (Part 1: dose escalation and Part 2: dose expansion) study evaluating multiple doses and schedules of intravenously (IV) administered HMBD-002, with or without pembrolizumab, in patients with advanced solid tumors (i.e., locally advanced and unresectable, or metastatic).

NCT ID: NCT05082259 Recruiting - Cervical Cancer Clinical Trials

ASTEROID: A Trial of ASTX660 in Combination With Pembrolizumab

ASTEROID
Start date: March 2, 2022
Phase: Phase 1
Study type: Interventional

This is a multi-centre Phase I dose finding and proof-of-concept study of the combination of ASTX660 together with Pembrolizumab with expansion cohorts testing preliminary efficacy in immune-refractory cancers, triple negative breast cancer (TNBC), cervical cancer, and glioblastoma. In contrast to the existing studies combining first-generation cIAP1/2 selective Smac mimetics with immune check point inhibitors, the ASTEROID Phase I clinical trial will be the first trial utilising triple cIAP1/2 and XIAP blockade by ASTX660 as a strategy to maximise immunogenic cell death and the generation of an efficient adaptive immune response. ASTX660 is not simply being used to repeat the data already being acquired with other first generation Smac mimetics. In contrast, we will investigate more in depth the mechanisms by which ASTX660 elicits its therapeutic effects both on tumour and on the host immune system. This will be critical to determine the best strategy to pursue in future later stage tumour specific trials of IAP antagonists in combination with immunotherapy, and to ensure appropriate molecular stratification biomarkers for the greatest benefit to patients.