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HER2-positive Breast Cancer clinical trials

View clinical trials related to HER2-positive Breast Cancer.

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NCT ID: NCT06450314 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests.

HEROES
Start date: November 15, 2024
Phase: Phase 2
Study type: Interventional

Heroes is a multicentre, national, non-randomized, open-label, phase 2 study. The goal of this clinical trial is to evaluate the feasibility of therapeutic de-escalation in HER2-positive metastatic breast cancer with disease controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND ctDNA negative testing. The main question it aims to answer is : • Is it possible to identify patients for whom temporary or permanent discontinuation of treatment is possible without impacting prognosis?

NCT ID: NCT06446882 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

Diagnostic HER2DX-guided Treatment for patIents wIth Early-stage HER2-positive Breast Cancer

DEFINITIVE
Start date: July 2024
Phase: N/A
Study type: Interventional

The primary goal of the DEFINITIVE trial is to demonstrate the effectiveness of the HER2DX diagnostic assay in enhancing the management of patients with early-stage HER2- positive breast cancer. Patients randomized to arm A will receive adjuvant treatment by physician´s choice, blinded to the diagnostic HER2DX test results. Patients randomized to Arm B will receive personalized treatment according to HER2DX results.

NCT ID: NCT06445400 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

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

This study is a phase II clinical trial to evaluate the safety and efficacy of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as first-line treatment in patients with unresectable locally advanced or metastatic HER2-positive breast cancer.

NCT ID: NCT06441890 Recruiting - Breast Cancer Clinical Trials

BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer

BRE-10
Start date: June 2024
Phase: Phase 2
Study type: Interventional

Adult men and women with early-stage, IHC/FISH-defined HER2-positive breast cancer will have a MammaPrint®/BluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care

NCT ID: NCT06439693 Not yet recruiting - Breast Cancer Clinical Trials

The SAPPHO Study: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

Start date: November 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants. The names of the study drugs involved in this study are: - Paclitaxel (a type of anti-microtubule agent) - Docetaxel (a type of anti-microtubule agent) - Nab-Paclitaxel (a type of anti-microtubule agent) - Trastuzumab (a type of IgG1 kappa monoclonal antibody) - Pertuzumab (a type of monoclonal antibody) - Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate) - Tucatinib (Tyrosine Kinase HER2 Inhibitor) - Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)

NCT ID: NCT06414733 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

Vaccine Therapy in Treating Patients With Metastatic Solid Tumors

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

This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.

NCT ID: NCT06386263 Recruiting - Clinical trials for Metastatic Breast Cancer

HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada

HER-TEMPO
Start date: April 22, 2024
Phase:
Study type: Observational

Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively. Multiple stakeholders, including clinicians, patients, regulators, and healthcare decision makers, are interested in real-world treatment-related outcomes in order to better represent the effectiveness of therapies in routine care settings.

NCT ID: NCT06358625 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer

CRANIUM
Start date: April 30, 2024
Phase:
Study type: Observational

HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease. At the time of diagnosis of metastatic disease, 7-11% of patients have brain metastases, with (70% of cases) or without symptoms (30% of cases). In the absence of brain metastases, 30% to 50% of patients will develop brain metastases within the first two years of treatment, depending on whether the disease is hormone receptor positive (HR+) or negative (HR-). The presence of brain metastases is the most important prognostic factor. The neurological symptoms caused by the presence of these lesions, but also by the local treatments offered, affect patients' quality of life, although improvements in surgical and radiotherapy techniques have significantly reduced the need for particularly toxic whole brain radiotherapy. International guidelines do not recommend systematic brain MRI in the absence of neurological symptoms, either in the adjuvant or metastatic stages of this disease. However, there may be a role for more systematic and earlier screening for cerebral recurrence, as single cerebral recurrences without extracranial involvement are common and the new anti-HER2 agents (i.e. tucatinib, an anti-HER2 tyrosine kinase inhibitor, and T-Dxd) have shown significant objective response rates in cerebral metastases. To date, no clinical or histological prognostic factor (proliferation index, HR expression, etc.) has been used to identify a population of patients at high risk of cerebral relapse, allowing monitoring and treatment to be personalised. New tools for these indications would significantly modify our clinical practice, allowing the identification of a subpopulation at high risk of cerebral recurrence, suitable for increased monitoring and therapeutic adjustment.

NCT ID: NCT06348134 Not yet recruiting - Breast Cancer Clinical Trials

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

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

Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

NCT ID: NCT06330012 Recruiting - Clinical trials for HER2-positive Breast Cancer

The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.

Start date: March 18, 2024
Phase: N/A
Study type: Interventional

This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.