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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: 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.

NCT ID: NCT06328738 Recruiting - Colorectal Cancer Clinical Trials

ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer

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

The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab, and chemotherapy in participants with advanced-stage HER2-positive colorectal cancer and breast cancer.

NCT ID: NCT06328465 Recruiting - Clinical trials for Triple Negative Breast Cancer

fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases

fREEDOM
Start date: November 22, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to understand whether DWB-MRI (Diffusion Whole Body-Magnetic Resonance Imaging) is useful for early detection of locoregional or distant recurrence and whether early diagnosis influences the prognosis in high-risk populations thanks to the possibility of being able to use a more effective treatment. The primary objective is to evaluate 5-year overall survival (OS) in patients with Human Epidermal Growth Factor Receptor 2 positive (HER2+) or high-risk Triple Negative (TN) undergoing surveillance with DWB-MRI.

NCT ID: NCT06316531 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Start date: April 2024
Phase: Phase 3
Study type: Interventional

This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had failed previous treatment with taxanes and trastuzumab.

NCT ID: NCT06313086 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer

Start date: March 2024
Phase: Phase 3
Study type: Interventional

A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer

NCT ID: NCT06281210 Recruiting - Breast Cancer Clinical Trials

Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery

BETTY-CRASY
Start date: December 11, 2023
Phase: N/A
Study type: Interventional

This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.

NCT ID: NCT06276868 Not yet recruiting - Breast Cancer Clinical Trials

Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer

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

This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy.

NCT ID: NCT06265428 Recruiting - Clinical trials for HER2-positive Breast Cancer

A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer

Start date: January 29, 2024
Phase: Phase 3
Study type: Interventional

This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.