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HER2-negative Breast Cancer clinical trials

View clinical trials related to HER2-negative Breast Cancer.

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NCT ID: NCT06407401 Not yet recruiting - Clinical trials for Musculoskeletal Pain

Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Women With Early Breast Cancer

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

This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+/HER2- early breast cancer with joint, muscle and/or bone pain caused by the endocrine therapy. The purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and/or bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).

NCT ID: NCT06388122 Recruiting - Clinical trials for Metastatic Breast Cancer

DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients

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

The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor.

NCT ID: NCT06382948 Not yet recruiting - Clinical trials for Advanced Breast Cancer

Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

ADELA
Start date: June 2024
Phase: Phase 3
Study type: Interventional

This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer. The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival. Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.

NCT ID: NCT06375798 Recruiting - Breast Cancer Clinical Trials

Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer

Start date: November 19, 2020
Phase:
Study type: Observational [Patient Registry]

A Single-center, open, prospective study,for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery.

NCT ID: NCT06351332 Recruiting - Breast Cancer Clinical Trials

ZAP-IT: ZN-c3 + Carboplatin + Pembrolizumab in mTNBC

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

This research is being done to evaluate the safety and effectiveness of a drug currently known as Azenosertib (ZN-C3) in combination with the drugs carboplatin and pembrolizumab in metastatic triple-negative breast cancer. The names of the study drugs involved in this study are: - Azenosertib (a type of WEE1 inhibitor) - Carboplatin (a type of platinum compound) - Pembrolizumab (a type of monoclonal antibody)

NCT ID: NCT06348654 Not yet recruiting - Breast Cancer Clinical Trials

New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer

InPERSON
Start date: March 30, 2024
Phase:
Study type: Observational

The goal of the InPerson study is to employ all resources in a digital listening platform to benefit the quality of life of patients (QoL) with advanced HER2-negative breast cancer. The care pathway of patients with this type of disease represents an optimal setting for the implementation of an innovative narrative medicine pathway that, aided by integrative therapies, aims to support and accompain them in their treatment journey with a continuum of care. Moreover, the narrative medicine platform will implement the actual "static" way to define QoL with the classic Patient-Reported Outcomes (PROs) questionnaires, that reflect the patient status at a certain time point and not as a dinamic entity. It is on the basis of these assumptions that the present application project on the use of the DNMLAB digital narrative diary in the oncology department of the Fondazione Policlinico Gemelli was born.

NCT ID: NCT06334432 Recruiting - Pancreatic Cancer Clinical Trials

Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors

Start date: March 14, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors.

NCT ID: NCT06253195 Recruiting - Breast Cancer Clinical Trials

BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

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

This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, as monotherapy or in combination with fulvestrant, letrozole, or other combination partners in Chinese participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced or metastatic solid tumors.

NCT ID: NCT06230055 Recruiting - Clinical trials for HER2-negative Breast Cancer

Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis

Start date: January 5, 2024
Phase: Phase 4
Study type: Interventional

This is a prospective, multicenter, randomized controlled, open-label investigator-initiated clinical study to evaluate the clinical efficacy and quality of life of intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy versus systemic chemotherapy alone in patients with Her-2 negative breast cancer with leptomeningeal metastasis.

NCT ID: NCT06176261 Recruiting - Breast Cancer Clinical Trials

DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

Start date: December 26, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain. The name of the study drug used in this research study is: Datopotamab deruxtecan (a type of antibody-drug conjugate)