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Breast Neoplasms clinical trials

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NCT ID: NCT01843725 Completed - Clinical trials for Metastatic Breast Cancers

Phase 1 Study Testing the Combination of Aflibercept and Capecitabine in Metastatic Digestive and Breast Cancers

MOMENTUM1
Start date: September 2013
Phase: Phase 1
Study type: Interventional

Prospective non randomized, non-comparative, dose escalation, two arms open phase I trial to assess the safety and tolerability of capecitabine given in combination with aflibercept in patients with measurable or evaluable, chemorefractory digestive tumors or breast tumors in terms of the Maximum Tolerated Dose (MTD) and the Dose-Limiting Toxicities (DLTs), To establish the Recommended Phase II Dose (RP2D) of capecitabine in combination with Aflibercept.

NCT ID: NCT01843608 Unknown status - Depression Clinical Trials

Effect of Combined Exercise Post-treatment Intervention in Lean Mass Recovery in Breast Cancer Survival.

WIM1
Start date: February 2013
Phase: N/A
Study type: Interventional

Breast cancer survival it is affected by the side effects related to the illness, the treatments or even the behavioral factors (e.g. inadequate diet, sedentary behavior) that create in this women an important quantity of psychological and physical disorders. Prior systematic reviews and meta-analyses have demonstrate that supervised aerobic training is a safe, feasible, and effective adjunct therapy to improve a broad range of physiological and psychological outcomes in women with early breast cancer. However the vast majority of studies to date have focused on the efficacy of exercise to improve symptom control outcomes in breast cancer patients either during or following the completion of adjuvant therapy. Most relevant consequences are found in women that have to undergo surgery as 16% to 43% of women with breast cancer suffer functional limitation in the shoulder, inflammation, pain or strength and flexibility reduction in upper body limbs one year after surgery with a high prevalence which is rising. Weight gain is associated with decreased quality of life and increased risk for several comorbid conditions, such as cardiovascular disease and diabetes. The most of the cardiopulmonary problems are induced by chemotherapy or radiotherapy, because of the treatments effect in the heart and its consequences in cardiorespiratory fitness of these women. These side effects become in important limitations to allow women return their normal life style. These limitations have a severe effect in decreasing of physical activity practice, which have visible consequences in increasing general fatigue and calcium deficiency in bones due to the age and some adjuvant treatments. Previous studies found that patients with breast cancer who gained modest amounts of weight were significantly more likely to experience disease recurrence and die from breast cancer and other causes that those who were weight stable. In addition, two thirds of the studies that have assessed body composition change in relation to weight gain in this patient population observe no net gain in muscle mass or loss in muscle mass as body weight and adipose tissue increase. These changes are defined as sarcopenic obesity. This kind of obesity is characterized by weight gain in the presence of lean tissue loss or absence of lean tissue gain. In addition fat tissue gain is related with other health disorders such as diabetes, functional limitations and poor survival levels. Treatment for this unique pattern of weight gain is an exercise intervention, especially strength training. Psychological effects have to be took account as cancer produce important aftermath. Large scientific evidence shows the psycho-emotional alterations in women diagnosed with breast cancer at some point in their life. World Health Organization (WHO) defines quality of life as "individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by the person's physical health, psychological state, level of independence, social relationships, personal beliefs and their relationship to salient features of their environment." Following this definition numbered of researches have been developed, presenting interest in both physiological and psychological changes and improvements, as show different studies. HYPOTHESIS The primary hypothesis of this study is that group exercise intervention, combining aerobic and strength training, will reduce lean mass and body fat tissue in breast cancer post treatment survival. Secondary hypothesis of this clinical trial are follows: 1. Combined exercise intervention will increase maximal strength level of chest press and leg press. 2. Combined exercise intervention will increase maximal cardiopulmonary capacity, assessed by Peak Oxygen Consumption(VO2peak), which has been confirmed as an important value in survivals. In addition, ACSM propose this value as the Gold Standard to assess fitness level. 3. Combined exercise intervention will increase global Isometric Strength Index, assessed by Grip Strength Dynamometer. 4. Combined exercise intervention will improve range motion in upper-limbs. 5. Patients Reported Outcomes (PROs), such as quality of life (QoL), Health perception and depression.

NCT ID: NCT01842321 Completed - Breast Cancer Clinical Trials

Abiraterone Acetate in Molecular Apocrine Breast Cancer

AMA
Start date: July 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to estimate antitumour activity of abiraterone acetate in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer.

NCT ID: NCT01840488 Completed - Breast Cancer Clinical Trials

BN83495 Phase I in Post-menopausal Women

Start date: April 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the optimal biological dose (OBD) of Irosustat (BN83495) in postmenopausal women with oestrogen receptor (ER) positive locally advanced or metastatic breast cancer with disease progression after prior hormonal therapy. This study is designed to provide necessary information on safety and dose response of BN83495, when given by repeated once daily oral administration, while achieving a maximal STS inhibition and a maximal reduction in plasma oestradiol (E2) and adiol levels. The data obtained will be used to plan further clinical studies.

NCT ID: NCT01840306 Completed - Breast Cancer Clinical Trials

Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer

Start date: October 12, 2012
Phase:
Study type: Observational

Primary Objective: (i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for the existence of RNAs/proteins identified in (i) and (ii). Secondary Objective: To develop a predictive model for use in the HER2 positive population based on the most accurate and sensitive combination of the identified biomarkers.

NCT ID: NCT01840293 Recruiting - Clinical trials for Primary Breast Cancer

Breast Cancer Proteomics and Molecular Heterogeneity

Start date: February 2013
Phase:
Study type: Observational

Primary objective: The primary objective is to define the proteomic and molecular characteristics of primary and recurrent/ metastatic breast tumours with special focus on the expression of S100 protein and the estrogen receptor (ER), progesterone receptor (PR) and epidermal growth factor receptor 2 (HER2) genes Secondary objective: - To expand our understanding of the complex molecular pathways dictating the progression of breast cancer and their response to different treatment regimes. - To relate proteomic findings to survival data - To identify potential serum markers of breast cancer progression

NCT ID: NCT01840163 Completed - Breast Cancer Clinical Trials

A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool

Start date: February 2014
Phase: N/A
Study type: Interventional

This study examines the impact of an online decision tool for patients with early stage invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas. Participants will be randomized to receive either a basic version of a decision tool (similar to existing website with breast cancer information) or an enhanced version (featuring a knowledge building component, a values clarification exercise, and a patient activation module). Our hypothesis is that patients who use the enhanced version of the tool will have greater knowledge of their test and treatment options, have a higher rate of high quality (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the decision-making process.

NCT ID: NCT01839838 Completed - Clinical trials for Stage IA-IIA Breast Cancer

APBI Proton Feasibility and Phase II Study

Start date: April 22, 2013
Phase: N/A
Study type: Interventional

The overall objectives of the study are to establish feasibility and acute side effects of accelerated partial breast irradiation therapy, along with more long-term side effects and clinical efficacy of treatment.

NCT ID: NCT01839045 Active, not recruiting - Breast Cancer Clinical Trials

Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification

Start date: March 2013
Phase: N/A
Study type: Observational [Patient Registry]

The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins in your blood samples. The biomarker results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.

NCT ID: NCT01837602 Completed - Clinical trials for Metastatic Breast Cancer

cMet CAR RNA T Cells Targeting Breast Cancer

Start date: April 2013
Phase: Phase 1
Study type: Interventional

An open-label, clinical trial of autologous cMet redirected T cells administered intratumorally (IT) in patients with breast cancer. Fifteen evaluable patients will be enrolled in stepwise fashion. Step 1 will enroll patients with metastatic breast cancer refractory to at least 1 standard therapy, step 2 will include newly diagnosed patients with operable triple negative breast cancer.