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Breast Neoplasms clinical trials

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NCT ID: NCT04368468 Completed - Clinical trials for Triple Negative Breast Cancer

Modifications of Immune Microenvironment Induced by Neoadjuvant Chemotherapy in Triple-negative BC

MIMOSA
Start date: June 15, 2020
Phase:
Study type: Observational

The prescription of neoadjuvant chemotherapy becomes a standard in women with HER2-positive or triple-negative breast cancer and allows a complete histological response (pCR) which represents a prognostic factor for survival. . The problem for patients who are not pCR is that they are currently receiving non-personalized adjuvant systemic treatment. The identification of biomarkers present in the residual disease would be a criterion to guide the choice of post-neoadjuvant adjuvant systemic treatment, in order to personalize it. At the present time, there is no published study describing extensively the immune micro-environment (ME) in breast cancer, whether before or after chemotherapy, nor its modification induced by chemotherapy. The team therefore propose to study in a retrospective and monocentric series, the modifications of the immune ME induced by a "standard" neo-adjuvant chemotherapy in patients with triple-negative CS, whether they are in complete histological response or not (n = twice 50). The main objective of this project is to describe the changes in the immune ME of triple-negative breast cancers induced by neoadjuvant chemotherapy for all patients (in pCR or not): - Quantification of TILs and subtypes of TILs (CD4 and CD8) - Expression of the three immune checkpoints that are PDL1, TIM3 and LAG3 - Describe the organization of the immune system (immunostaining on the same slide of the PDL1, TIM3 and LAG3 immune checkpoints)

NCT ID: NCT04368442 Recruiting - Clinical trials for Breast Cancer Metastatic

Cohort Study of Patients With HER2-negative MBC and BRCA 1/2 Pathogenic Mutation

BRCAm
Start date: October 17, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to investigate the prevalence germline pathogenic BRCA1/2 mutation in a large group of potential candidate of PARP inhibitors, among the unselected patients with HER2-negative unresectable locally advanced or metastatic breast cancer.

NCT ID: NCT04367090 Completed - Clinical trials for Metastatic Breast Cancer

Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer

Start date: May 28, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC. The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.

NCT ID: NCT04366713 Completed - Clinical trials for HER2 Amplified Breast Cancer

A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib

Start date: June 30, 2020
Phase: Phase 2
Study type: Interventional

This study will investigate colon pathology in patients with HER2-positive breast cancer treated with neratinib. Colonoscopy will be performed after eligibility has been confirmed, prior to administration of the first dose of neratinib, and after 28 days of neratinib treatment.

NCT ID: NCT04365803 Active, not recruiting - Breast Cancer Clinical Trials

Histology VABB-Histology Post Surgery Pilot Project (BETTY Trial)

BETTY
Start date: June 1, 2018
Phase:
Study type: Observational

Pilot study on patients with invasive ductal breast cancer triple negative or receptor tyrosine-protein kinase erbB-2 (HER2) overexpressed, any axillary lymphnodes status (any cN), candidates to neoadjuvant chemotherapy. The principal endpoint of the study will be the accuracy of the result of the histological examination of the Vacuum- Assisted Breast Biopsy (VABB) performed pre-surgery in comparison to the result of the histological examination of the definitive surgical intervention in patients with radiological complete response at Magnetic resonance imaging (MRI) done after the end of neoadjuvant chemotherapy.

NCT ID: NCT04365790 Active, not recruiting - Breast Cancer Clinical Trials

Investigation of Gene Mutations in Patients With Triple-negative and Patients With HER2+ Breast Cancer Adenocarcinoma

Start date: April 18, 2013
Phase:
Study type: Observational

The present study is a transnational study in patients with high risk recurrent breast cancer who receive adjuvant chemotherapy with epirubicin and cyclophosphamide followed by docetaxel or paclitaxel.

NCT ID: NCT04365569 Recruiting - Breast Cancer Clinical Trials

Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program

Start date: January 6, 2021
Phase: N/A
Study type: Interventional

More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.

NCT ID: NCT04364672 Recruiting - Breast Cancer Clinical Trials

Molecular Neuroimaging to Assess the Link Between Neuroinflammation and Cognitive Impairment in Breast Cancer

Start date: June 1, 2025
Phase: Phase 1
Study type: Interventional

This clinical study will use the small molecule translocator protein (TSPO) ligand, 18F-labeled DPA-714, to visualize and quantify neuroinflammation in treatment naive women with stage II-III newly diagnosed breast cancer (without brain metastases) prior to starting neoadjuvant chemotherapy treatment (baseline) and within 4 weeks after finishing neoadjuvant chemotherapy (NACT) with at least 2 cycles administered and before surgery. . The TSPO PET and MRI data acquired through this study will be correlated with cognitive test data, clinical data, and genetic testing collected in this study. We will enroll 20 participants in this study (20 participants with breast cancer). Study Aim 1: To examine the association between neuroinflammation and cancer related cognitive impairment (CRCI) in women with breast cancer before and after undergoing chemotherapy treatment. (Hypothesis 1): Treatment-naïve women with Stage II-III breast cancer (without known brain metastases) will experience increased amount of neuroinflammation and greater cognitive decline after completing neodjuvant Chemotherapy Treatment (NACT). (Hypothesis 2): Greater levels of neuroinflammation as measured by the amount and distribution of [18F]DPA-714 in the brain using PET/MRI after completing NACT will be associated with lower levels of cognitive functioning as measured by self-report and/or objective cognitive impairment/change. Neuroinflammation will be measured using PET with tracer [18F]DPA-714 using a simultaneous PET/MRI system, and cognitive functioning will be measured with self-report and objective neuropsychological measures. Exploratory Aim 2: To investigate the relationships between CRCI and quality of life (QOL) and everyday functioning in breast cancer survivors after completing chemotherapy treatment. For this Aim, we will assess QOL using self-report measures.

NCT ID: NCT04364347 Recruiting - Breast Neoplasms Clinical Trials

Chemotherapy-induced Circadian Rhythm Disruption

Start date: December 14, 2019
Phase:
Study type: Observational

The purpose of this study is to investigate chemotherapy-induced circadian rhythm disruption through biomarkers, and the relationship between chemotherapy-induced circadian rhythm disruptions and side effects of chemotherapy.

NCT ID: NCT04362826 Not yet recruiting - Breast Cancer Clinical Trials

Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effect of probiotics on the breast tumor microbiome and gut microbiome in breast cancer. Microorganisms that make up the microbiome (such as viruses, bacteria, and fungi) may have an important role in breast cancer development. Understanding the association of microorganisms with breast cancer may enable new ways to prevent, diagnose, and treat breast cancer. The probiotic, BIOHM, which is owned and distributed by BIOHM Health LLC, will be used in this study. BIOHM is a food supplement that is believed to balance bacteria and fungi in the body and has received the designation as Generally Recognized as Safe (GRAS) by the Food and Drug Administration (FDA). This study is being done to determine the effectiveness of BIOHM in breast cancer.