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Triple Negative Breast Cancer clinical trials

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NCT ID: NCT05633654 Recruiting - Clinical trials for Triple Negative Breast Cancer

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63)

Start date: December 12, 2022
Phase: Phase 3
Study type: Interventional

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

NCT ID: NCT05632848 Recruiting - Clinical trials for Triple Negative Breast Cancer

Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients

Start date: June 15, 2022
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy.

NCT ID: NCT05627960 Recruiting - Clinical trials for Non Small Cell Lung Cancer

First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies

Start date: February 14, 2022
Phase: Phase 1
Study type: Interventional

This is a first in human phase 1 study of AG01 an anti-Progranulin/Glycoprotein88 (PGRN/GP88) antibody in patients with advanced solid tumors. AG01 is a recombinant monoclonal antibody expressed in a CHO production cell line. The antibody AG01 binds to human PGRN/GP88, expressed on cancer cells. This study will have a dose escalation portion (1A) to evaluate maximum tolerated dose (MTD) and/or maximum administered dose (MAD), the safety and tolerability of AG01treatment before the dose expansion portion (1B) of the study is initiated. The dose escalation portion of this study (1A) will also be used to determine the recommended phase 2 dose (RP2D) of AG01 antibody to be evaluated in the cohort expansion portion (1B).

NCT ID: NCT05620134 Recruiting - Cancer Clinical Trials

Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer

Start date: October 17, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of subcutaneously administered JK08 in patients with unresectable locally, advanced or metastatic cancer.

NCT ID: NCT05579366 Recruiting - Ovarian Cancer Clinical Trials

PRO1184 for Advanced Solid Tumors

PRO1184-001
Start date: December 7, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1184 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

NCT ID: NCT05565417 Recruiting - Colorectal Cancer Clinical Trials

Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

Start date: November 28, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2a open-label, multicenter, dose escalation and dose expansion trial in which IMT-009 will be administered by the intravenous (IV) route to participants with solid tumors or lymphomas. The main goals of this study are to: - Find the recommended dose of IMT-009 that can be safely given to participants - Learn more about the side effects of IMT-009 - Learn more about pharmacokinetics of IMT-009 - Learn more about the effectiveness of IMT-009 - Learn more about different pharmacokinetic biomarkers and how they might change in the presence of IMT-009

NCT ID: NCT05556200 Recruiting - Breast Cancer Clinical Trials

A Phase II Trial of Camrelizumab in Combination With Apatinib for Neoadjuvant Treatment of Early-stage TNBC With a High Proportion of TILs

Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

This is a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with apatinib (a VEGFR2 TKI) for neoadjuvant treatment of patients with triple-negative breast cancer and >10% tumor-infiltrating lymphocytes (TILs) in baseline breast tumors. We will enroll 58 subjects (Simon's two stage design). The study is designed to evaluate the efficacy and safety of camrelizumab in combination with apatinib in the neoadjuvant treatment of TNBC with a high proportion of TILs.

NCT ID: NCT05552001 Recruiting - Clinical trials for Metastatic Breast Cancer

Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer

ISIdE
Start date: October 5, 2023
Phase: Phase 3
Study type: Interventional

ISIdE is an European, multicentric study that aims to assess the efficacy of Sacituzumab Govitecan (SG) in locally advanced or metastatic triple-negative breast cancer where the disease has progressed despite chemotherapy or within 6 months after the end of curative treatments in order to: 1. evaluate the treatment efficacy in less pretreated patients. 2. identify biomarkers that could predict response or resistance to the drug. 100 patients will be included in this trial.

NCT ID: NCT05550415 Recruiting - Clinical trials for Triple Negative Breast Cancer

The Role of Simvastatin in The Epithelial-Mesenchymal Transition Process of Breast Cancer

Start date: August 19, 2022
Phase: Phase 2
Study type: Interventional

Introduction: Most cases of Triple Negative Breast Cancer (TNBC) have a high proliferation rate. TNBC is associated with a poor prognosis, a high recurrence rate, and a high incidence of distant metastases. The Epithelial-Mesenchymal Transition process (EMT) plays an essential role in the metastatic process. EMT markers were also more abundant in TNBC and contributed to a poorer TNBC prognosis. As an important EMT marker, the increased expression of vimentin also contributed to the increase in TNBC aggressiveness and resistance to chemotherapeutic agents. Through the mechanism of action in inhibiting the mevalonate pathway, statins can help inhibit the EMT process in metastases. Notably, simvastatin promotes the down-regulation of vimentin in breast cancer cells. The combination of statins and neoadjuvant chemotherapy (NAC) improves the cancer patient's response. This study is expected to evaluate the role of a combination between NAC and simvastatin on therapeutic response in TNBC patients through vimentin expression. Methods: This study is a double-blind, randomized, placebo-controlled trial conducted in Dr. Cipto Mangunkusumo National Central General Hospital. An expected total of 26 TNBC patients will be assessed for eligibility and asked for informed consent. Patients with the plan to have ACT (Doxorubicin hydrochloride, Cyclophosphamide, Paclitaxel) chemotherapy regimen will receive either a combination of ACT-Simvastatin (40 mg/day) or ACT-Placebo. The biopsy will be taken pre-NAC to make the histopathological diagnosis and examine the expression of vimentin. Patients will be evaluated for adverse effects reaction every cycle and the clinical response after 8 cycles. The post-intervention biopsy will be conducted after the cycle finish. The pathological response and vimentin expression will be reviewed from the obtained samples.

NCT ID: NCT05546255 Recruiting - Clinical trials for Triple Negative Breast Cancer

Eribulin Mesylate Combined With Lobaplatin in the Treatment of Recurrent or Metastatic Triple-negative Breast Cancer

Start date: June 1, 2020
Phase: Phase 2
Study type: Interventional

A prospective phase II study conducted at the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of eribulin combined with lobaplatin in the treatment of recurrent or metastatic triple-negative breast cancer