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Breast Neoplasms clinical trials

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NCT ID: NCT05293964 Recruiting - Breast Cancer Clinical Trials

Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer

Start date: May 18, 2022
Phase: Phase 1
Study type: Interventional

This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen receptor (ER) -positive, human epidermal growth factor receptor (HER-2) -negative locally advanced or metastatic breast cancer.

NCT ID: NCT05293470 Recruiting - Breast Cancer Clinical Trials

A Post Marketing Surveillance on Piqray in Korea

Start date: June 29, 2022
Phase:
Study type: Observational

This is a prospective, multicenter, open-label, non-comparative, non-interventional, observational study to assess te safety and effectiveness of Piqray in the real-world setting

NCT ID: NCT05292742 Recruiting - Breast Cancer Clinical Trials

Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer

Start date: July 2, 2021
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor (primary breast tumor/axillary lymph nodes) who did not achieve pCR after neoadjuvant therapy

NCT ID: NCT05289258 Recruiting - Cancer, Breast Clinical Trials

Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments

Start date: January 25, 2021
Phase: N/A
Study type: Interventional

Background: Cognitive impairment appears frequently in cancer survivors, negatively affecting the quality of life and emotional well-being of patients. This study compares the effectiveness of a well-established treatment (cognitive rehabilitation) with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) to alleviate these cognitive deficits and evaluate its effect on anxiety-depressive symptoms and the quality of life of survivors. Methods: A three-arm randomized superiority clinical trial, with a pre-post and follow-up repeated measures and intergroup design with a 1:1:1 allocation ratio will be carried out. A hundred and twenty-three breast cancer survivors with mild to moderate cognitive impairment will be randomly assigned to one of the interventions of the study: cognitive rehabilitation intervention group, an intervention group with UP intervention, or a control group on the waiting list. The primary outcome is to observe a significant improvement in cognitive function and quality of life in both intervention groups and a significant decrease in emotional impairments in comparison with the waitlist group. These results will be maintained at six months of follow-up. Discussion: The aim of this work is to test the efficacy of the Unified Barlow Protocol in reducing cognitive deficits in breast cancer survivors. The results of this trial may be useful in reducing the presence of cognitive problems in survivors and improving their emotional state and quality of life.

NCT ID: NCT05288777 Recruiting - Breast Cancer Clinical Trials

Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer

Breast53
Start date: July 11, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and/or mastectomy and were found to have residual disease. As well as examine the effects of this treatment combination on the immune system.

NCT ID: NCT05288127 Recruiting - Clinical trials for Triple Negative Breast Cancer

Efficacy of Talazoparib in Asian Metastatic Breast Cancer Patients With a Homologous Recombinant Deficiency (HRD) Signature

Start date: March 8, 2022
Phase: Phase 2
Study type: Interventional

This is an open label, non randomised, investigator-initiated Phase II study of single agent talazoparib (Talzenna®) in metastatic triple negative breast cancer patients with enriched HRD signature. Approximately 55 subjects will be enrolled in this study to examine the efficacy of talazoparib when given orally 1mg daily for days 1 to 28 for up to 28 months. The study will be conducted using the Simon two-stage phase II design, whereby this study will initially enroll 19 patients with RECIST v1.1 measurable disease with enriched HRD signature (stage I). There will be one interim analysis at the end of stage I and if 3 of the 19 have a response, then no further patient will be accrued. If 4 or more of the 19 patients have a response, then accrual would continue to stage II until a total of 55 patients have been enrolled. This study will be conducted in conformance with Good Clinical Practices. Specific procedures to be performed during the trial, as well as their prescribed times and associated visit windows, are outlined in the Trial Flow Chart.

NCT ID: NCT05286684 Recruiting - Breast Cancer Clinical Trials

Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis (Exo-LCR)

Exo-LCR
Start date: January 4, 2023
Phase: N/A
Study type: Interventional

The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis.

NCT ID: NCT05286437 Recruiting - Clinical trials for Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer

Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole

LaPemERLA
Start date: February 15, 2023
Phase: Phase 2
Study type: Interventional

This is a phase II study testing the combination of pembrolizumab with lenvatinib, a multi-kinase inhibitor that has activity against vascular endothelial growth factor receptors 1-3 (VEGFR1-3), fibroblast growth factor receptors 1-4 (FGFR1-4), ret protooncogene (RET), platelet-derived growth factor receptor-alpha (PDGFR-alpha) and KIT (a stem cell factor receptor), and letrozole, a non-steroidal aromatase inhibitor, in advanced hormone receptor (HR) positive human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC) that has progressed on/after standard endocrine therapy.

NCT ID: NCT05280067 Recruiting - Clinical trials for Metastatic Breast Cancer in the Spine

ZetaFuse™ Bone Graft in the Repair of Bone Defects From Metastatic Breast Cancer in the Spinal Vertebral Body

ZGMBC
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The ZetaFuse™ Bone Graft is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites, with at least one metastatic lesion located in a vertebral body of the spine, and a Spinal Instability Neoplastic Score (SINS) ≥3 and ≤9. The ZetaFuse™ Bone Graft is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. The ZetaFuse™ Bone Graft is only for implantation into the vertebral body.

NCT ID: NCT05278741 Recruiting - Breast Cancer Clinical Trials

Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.

BREAST
Start date: November 25, 2022
Phase: N/A
Study type: Interventional

This study will quantify the muscle function after breast reconstruction using a minimally invasive latissimus dorsi flap. The proposed measures (clinical, isokinetic, electrophysiology, function and quality of life questionnaires) allow a precise, multidisciplinary, objective evaluation of the capacity of the latissimus dorsi muscle before surgery, 3 months and 6 months after surgery. A function deficit is expected (decreased moment of adduction and internal rotation) 3 months after surgery and a return to the preoperative state 6 months after surgery.