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Breast Neoplasms clinical trials

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NCT ID: NCT03429296 Completed - Breast Cancer Clinical Trials

Autohypnosis and Cancerology

Start date: May 23, 2018
Phase: N/A
Study type: Interventional

Therapeutical hypnosis is proven to be an effective medical support to chemotherapy: it was shown that it can reduce the pain, anxiety, fatigue felt by the patient. Yet, hypnosis requires the presence of an hypnotherapist, which is why auto-hypnosis could be an efficient alternative to handle the side effects of chemotherapy. In this study, colorectal cancer and breast cancer patients are either taught auto-hypnosis or are taken in standard care for their chemotherapy. The life quality score (QLQC30) assessed during and after chemotherapies will determine if auto-hypnosis is a good medical support in chemotherapies' adverse effects management. The proven benefices of auto-hypnosis in the handling of the side effects of chemotherapies could improve the quality of life of cancer affected patients.

NCT ID: NCT03427450 Completed - Healthy Volunteers Clinical Trials

Harvest of CTCs From MBC Patients Using the Parsortix™ PC1 System

HOMING
Start date: March 29, 2018
Phase:
Study type: Observational

The purpose of this clinical study is to demonstrate that the Parsortix™ PC1 system enables the capture and harvest of circulating tumor cells (CTCs) from the peripheral blood of patients with metastatic breast cancer (MBC) and not from healthy volunteers (HVs). The study is also designed to demonstrate that the CTCs harvested by the Parsortix PC1 system from MBC patients can be used effectively for different types of evaluations (e.g. cytopathology, FISH, qPCR, RNAseq, etc.). This is an investigational study. The Parsortix PC1 system is not FDA approved and is currently being used for research purposes only.

NCT ID: NCT03425656 Completed - Clinical trials for Malignant Neoplasm of Breast

Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer

Start date: July 9, 2016
Phase: Phase 3
Study type: Interventional

This is A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study to evaluate efficacy and safety of AryoTrust (Aryogen Trastuzumab in comparison to Herceptin® (Genentech/Roche) in patients with Human Epidermal Growth Factor Receptor 2-Positive breast cancer. The main objective is to verify the non-inferiority of AryoTrust (Aryogen trastuzumab) vs. Herceptin® (Genentech/Roche trastuzumab), both given concomitantly with docetaxel after doxorubicin plus cyclophosphamide in the neoadjuvant setting according to pathological complete response (pCR) as primary objective and objective response (cOR), clinical complete response (cCR), clinical partial response (cPR), clinical stable disease (cSD), clinical progressive disease (cPD), breast conservation rate as Secondary objectives of this study. Evaluating the safety and immunogenicity of AryoTrust vs. Herceptin®, are also the other secondary outcomes. This study has two arms and 108 subjects will participate with a 1:1 allocation and receive mentioned treatment randomly.

NCT ID: NCT03420105 Completed - Breast Cancer Clinical Trials

Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep

PROSOM-K
Start date: January 5, 2018
Phase: N/A
Study type: Interventional

The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.

NCT ID: NCT03419026 Completed - Breast Cancer Clinical Trials

Pregnant Exposure to Persistent Organic Pollutants

Start date: May 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

Breast cancer, the first female cancer, affects one in eight women in her lifetime. The increase and uneven distribution of its prevalence throughout the world cannot be fully explained either by the increase in life expectancy, or by genetic factors present in less than 10% of cases, or by early detection, or by the use of hormone therapy for menopause at certain periods of time. Numerous experimental and epidemiological arguments, as well as the increased risk of breast cancer in women after 50 years of age who were exposed in utero to Distilbene prescribed for their mothers in the 1950s to 75's, suggest the involvement of environmental factors involved in early development (nutrition, alcohol, tobacco, chemical pollutants) that may act as endocrine disruptors, estrogenomimetic or intervening on other nuclear receptors such as the However, the formal demonstration of the deleterious physiopathological role of such exposure comes up against methodological difficulties in epidemiological terms: first of all, the fact that correlation is sought at the time of the discovery of breast cancer when there are critical windows of exposure (fetal, perinatal, peripubertal and pregnant) and that persistent organic products or POPs, most often lipids, are present. The objective of this project is to correlate the per-gravidic exposure to POPs (dioxins, dioxinlike, polychlorinated bisphenyls, organochlorine pesticides and flame-retardant polybrominated derivatives) and the development, within 15 years of delivery, of breast cancer, taking into account the confounding factors of classical breast cancer risk (age, reproductive events, etc.). This project benefits on the one hand from a cord blood bank set up between 2002 and 2005 (6,242 samples) carried out at the Nice University Hospital and the Grasse University Hospital, during a PHRC and on the other hand from the cancer observatory / CRISAP of the PACA Corsica region, exhaustive to more than 92% since 2005, registers which will be cross-referenced and whose cancer cases (N) will be compared to controls. The assays will be carried out after purification, using high-resolution mass spectrometry gas chromatography coupling, the quantification being carried out according to the principle of isotopic dilution. They will be carried out by LABERCA in Nantes, the national reference laboratory of the French Health Agencies ANSES and INVS and also involved in various European projects. Concentrations related to blood lipids will be expressed in quartile and analyzed separately or combined with a cumulative score taking into account confounding risk factors for breast cancer and the geolocation of the initial and final residence in relation to the incinerator of the City of Nice (Department of Public Health CHU of Nice).

NCT ID: NCT03413761 Completed - Clinical trials for Node Positive Breast Cancer

Antioxidant Supplements, Genetics and Chemotherapy Outcomes

Start date: December 18, 2004
Phase:
Study type: Observational

This study will investigate the null hypothesis that use of antioxidant supplements during adjuvant chemotherapy will have no impact on toxicities and disease-free, as well as overall, survival, and also evaluate the role of polymorphisms in genes related to oxidative stress in relation to treatment outcomes.

NCT ID: NCT03411161 Completed - Clinical trials for Metastatic Breast Cancer

S 81694 Plus Paclitaxel in Metastatic Breast Cancer

Start date: January 4, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in metastatic breast cancer (mBC) patients, and to investigate the antitumour activity of the combination in metastatic triple negative breast cancer (mTNBC) patients.

NCT ID: NCT03411070 Completed - Clinical trials for Stage IIIC Breast Cancer AJCC v7

SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer

Start date: April 7, 2019
Phase: Early Phase 1
Study type: Interventional

This pilot clinical trial will evaluate whether the SCOUT reflector can be used to tag abnormal lymph nodes in patients with breast cancer prior to chemotherapy for targeted removal at the time of surgery. The SCOUT localization system with the SAVI reflector is non-radioactive and completely internal so can be placed into an abnormal lymph node prior to chemotherapy treatment, which theoretically will allow easier identification and therefore more reliable targeting of the abnormal lymph node for surgical removal.

NCT ID: NCT03409198 Completed - Breast Cancer Clinical Trials

Phase IIb Study Evaluating Immunogenic Chemotherapy Combined With Ipilimumab and Nivolumab in Breast Cancer

ICON
Start date: January 21, 2018
Phase: Phase 2
Study type: Interventional

Breast cancer is rarely curable after metastasis, and the therapeutic options are limited. Interestingly, the host immune response is strongly predictive for the effect of chemotherapy in subgroups of patients with breast cancer. The aim is to release the brake on the immune response by use of ipilimumab, which blocks CTLA-4 and may deplete regulatory T cells, combined with nivolumab (anti PD1). Importantly, it is possible that non-responders to nivolumab/ipilimumab (nivo/ipi) can be turned responders by use of immunogenic chemotherapy.

NCT ID: NCT03408769 Completed - Clinical trials for Metastatic Breast Carcinoma

Metastatic Breast Carcinoma and Women Sexual Quality of Life

SexoMBC
Start date: March 12, 2018
Phase:
Study type: Observational

Sexual health is one of the relevant parameters for assesing the quality of life. Improvement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase. The purpose of the study is to assess the quality of sexual life of postmenopausal women with metastatic breast cancer in couples and to establish links with overall quality of life and the quality of the relationship.