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Triple Negative Breast Neoplasms clinical trials

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NCT ID: NCT06409221 Enrolling by invitation - Clinical trials for Triple Negative Breast Cancer

VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study

Start date: May 1, 2024
Phase:
Study type: Observational

Background: Despite improvements in the treatment of Triple Negative Breast Cancer (TNBC), the cancer returns in half of the women and shockingly 40% are dead within 5 years of their initial cancer diagnosis. There is an urgent need to identify reliable biomarkers of response for chemotherapy and immunotherapy. Study Aims: To update Concr's existing predictive algorithms specifically for use in women newly diagnosed with TNBC. The plan is develop technology which will predict which drug the cancer will respond best to, treatment A vs. treatment B AND how the individual's prognosis could change if treatment A is chosen overtreatment B. Study Design: The VISION study is a clinical study looking back in time (retrospective study), specifically focusing on women who were previously diagnosed with early Triple Negative breast cancer and received chemotherapy followed by curative breast surgery. The plan is to collect historical clinical data and previously collected cancer biopsy samples from up to 200 women in order to update Concr's existing treatment prediction algorithms. Hence there are no extra research biopsies needed in order to participate in the Study. Study Sites: UK and Australia Study Funding: This study is funded by the a Techbio company called Concr with support from Innovate UK (UK Government funding).

NCT ID: NCT06407310 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

Neoadjuvant Pembrolizumab, Carboplatin and Paclitaxel in Triple-negative Breast Cancer

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

This is a phase II, single-centered, open-label, single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological complete response (pCR) rate of a non-anthracycline-based chemo-immunotherapy regimen. The trial includes a lead-in cycle of pembrolizumab, then a combination of paclitaxel, carboplatin, and pembrolizumab in the neoadjuvant setting.

NCT ID: NCT06405295 Not yet recruiting - Clinical trials for Early-stage Triple-negative Breast Cancer With BRCA1/2 Mutations

A Multicentre Prospective Cohort Study: Intensive Adjuvant Therapy for TNBC With BRCA Gene Mutation

Start date: May 6, 2024
Phase:
Study type: Observational

Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.

NCT ID: NCT06404736 Not yet recruiting - Neoadjuvant Therapy Clinical Trials

QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer

QUEEN-Dream
Start date: May 7, 2024
Phase: Phase 2
Study type: Interventional

This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel and carboplatin in a neoadjuvant setting, in high-risk, TNBC early breast cancer.

NCT ID: NCT06401005 Not yet recruiting - Breast Cancer Clinical Trials

SBRT, Chemotherapy, and AK112 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

Studies have indicated that the improvement in pathological complete response (pCR) is significantly correlated with triple-negative breast cancer(TNBC)patients' overall survival (OS). Patients with TNBC have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of TNBC patients, increasing it from 45% to approximately 60%. Therefore, how to further improve the pCR rate of luminal-type breast cancer became the main objective of this study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+ T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and efficacious in lung cancer patients. Ivonescimab (AK112) is an anti-PD-1/VEGF-A bispecific antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was proposed to explore the safety and efficacy of SBRT+AK112+chemotherapy, a neoadjuvant treatment modality, in the treatment of TNBC.

NCT ID: NCT06400472 Not yet recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Start date: May 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

NCT ID: NCT06399757 Not yet recruiting - Prostate Cancer Clinical Trials

A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors

Start date: May 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-5125 for the treatment of selected locally advanced or metastatic solid tumors with particular focus on Colorectal carcinoma (CRC).

NCT ID: NCT06396754 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC

AIDOBE
Start date: June 1, 2024
Phase:
Study type: Observational

TILs have been shown to be predictive for response to neo-adjuvant chemotherapy in patients with TNBC in multiple studies (Level-1B evidence for clinical validity as per REMARK criteria). TNBC patients with excellent survival outcome and low incidence of metastasis can be identified using a manual TIL score. Furthermore, a fully end-to-end blinded evaluation of the same algorithm to be used in this study achieved >90% accuracy for predicting disease free survival (DFS) and overall survival (OS) in the pooled analysis of seven adjuvant phase-III TNBC trials.

NCT ID: NCT06393374 Not yet recruiting - Clinical trials for Triple-Negative Breast Cancer

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR

Start date: May 24, 2024
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (sac-TMT; MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sac-TMT plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sac-TMT plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

NCT ID: NCT06387628 Recruiting - Clinical trials for TNBC - Triple-Negative Breast Cancer

LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer

Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of LM108 plus toripalimab plusnab-paclitaxel or eribulin as first-line or post-line treatment in patients with metastatic triple-negative breast cancer.