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Breast Neoplasms clinical trials

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NCT ID: NCT01558258 Completed - Clinical trials for Younger Breast Cancer Survivors

A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

Start date: April 2011
Phase: Phase 2
Study type: Interventional

Younger women with breast cancer experience substantially greater distress and depressive symptoms than older women. These symptoms can hamper recovery and healthy behaviors that can reduce the risk of recurrence and/or other chronic diseases. The primary objective of this study is to evaluate the feasibility and preliminary efficacy of a mindfulness meditation-based intervention for this at-risk group of women. The investigators hypothesize that a structured program of mindfulness meditation will lead to significant improvements in psychological well-being (i.e., depression, stress), with corresponding improvements in health behaviors and biomarkers of cancer risk, in women diagnosed with breast cancer, prior to age 50. The investigators will also examine mechanisms for intervention effects, including increased mindfulness and ability to relax.

NCT ID: NCT01556243 Completed - Breast Cancer Clinical Trials

Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

Start date: July 2012
Phase: Phase 2
Study type: Interventional

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer

NCT ID: NCT01555944 Completed - Clinical trials for Metastatic Breast Cancer

Prospective Observational Study in Patients With Metastatic Breast Cancer Treated With Anthracyclines

Start date: February 2012
Phase: N/A
Study type: Observational

This is an open, multicentre, prospective observational (non-interventional) study, performed in Belgium. Principal objectives: 1. To evaluate the prevalence of cardiovascular risk factors and cardiac function (as routinely evaluated) before treatment with anthracyclines of patients with metastatic breast cancer (MBC) aged > or = 65 years 2. To observe the management of cardiovascular risk during and after anthracycline treatment 3. To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac function, outcome and quality of life (EORTC QLQ-C30) Secondary objectives: 1. To evaluate the efficacy of anthracyclines on progression free survival and tumor response as routinely measured (e.g. recist criteria, tumor markers and other exams) 2. To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection fraction, heart failure and rate according to allocated treatment. 3. To find out how quality of life, e.g. such as described according to EORTC QLQ-C30 criteria or Karnofsky index is achieved in the various patient subgroups 4. To correlate the therapeutic choice and posology of anthracyclines for MBC with Cardiovascular risk at baseline 5. To calculate the cardiovascular risk according to SCORE

NCT ID: NCT01555645 Completed - Breast Cancer Clinical Trials

Stress Management in Breast Cancer Patients

Start date: May 2009
Phase: N/A
Study type: Interventional

The purpose of this study within Caring sciences is to identify women with breast cancer who have stress symptoms and to offer these women appropriate care to reduce stress and increase well-being. This will be achieved by 1. Studying the prevalence of stress related symptoms in female patients with breast cancer 2. Testing the use of two short screening instruments to identify women at risk for developing long-standing stress symptoms 3. Studying the level and intensity of stress management interventions required to achieve increased well-being, using a stepped-care approach. 4. Studying the effects of interventions based on cognitive behavior therapy, delivered individually or in a group format. The hypothesis is that half of the individuals assigned to a low intensity intervention will be significantly improved after treatment. For individuals who continue to have symptoms after low intensity treatment it is hypothesized that continued treatment in a group setting with high intensity interventions will be more cost-effective. In addition the assumption is that reduction of stress symptoms in women with breast cancer will lead to a reduction in socio-economic costs.

NCT ID: NCT01554943 Completed - Breast Cancer Clinical Trials

Late Cardiac Evaluation of the Three Arm Belgian Trial Involving Node-positive Early Breast Cancer Patients

Start date: July 2010
Phase: Phase 2
Study type: Interventional

Late Cardiac Evaluation of the Three Arm Belgian Trial A phase III randomized trial involving node-positive early breast cancer patients with a long median follow-up (~ 15 years) OBJECTIFS Primary: • To compare the incidence of late cardiac events between anthracycline and non-anthracycline chemotherapy given to node-positive breast cancer patients in the Belgian three arm randomized clinical trial Secondary: - To compare the late incidence of cardiac events between higher and lower dose anthracycline treated node-positive breast cancer patients; - To compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy for: - left ventricular diastolic function assessed by Echo - exercise capacity assessed by 6-minute walk test (6MWT) - cardiac morphology (myocardial inflammation or injury, fibrosis, LVEF) assessed by MRI - serum cardiac biomarkers (BNP and TNT) - patient-reported cardiac symptoms - patient-reported cardiac symptoms assessed by QOL questionnaires are associated with subclinical findings on LVEF assessment - cognitive function, functional autonomy, and psychological distress

NCT ID: NCT01554371 Completed - Neuropathy Clinical Trials

Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies

Start date: March 27, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety of eribulin (Halaven™) and cyclophosphamide (Cytoxan®) given together at different doses. This study will look at what effects, good and/or bad, that these drugs have on solid tumors. Eribulin is a drug that has been approved by the FDA for breast cancer that has spread to other parts of the body. Cyclophosphamide has been approved for different types of cancers (including breast cancer). However, the combination of eribulin and cyclophosphamide is considered experimental; that means this combination has not been approved by the FDA. The funding for this study is provided by Eisai Inc., the maker of eribulin.

NCT ID: NCT01553903 Completed - Breast Cancer Clinical Trials

Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not

OXYTAM
Start date: December 2011
Phase: Phase 4
Study type: Interventional

This is a biomedical study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up. Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be enrolled in this study. The main objective of this study is to evaluate the feasibility for the determination of Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of treatment (ie, at D0 before and D28 after beginning of treatment).

NCT ID: NCT01553097 Completed - Breast Cancer Clinical Trials

Examining a Common Complaint of Women Who Receive Chemotherapy for Breast Cancer- Cognitive Difficulty

Start date: March 2012
Phase: N/A
Study type: Observational

This longitudinal project will investigate a common complaint of women who receive chemotherapy for breast cancer- cognitive difficulty. The relationships of fatigue, stress, and depression to cognitive difficulties will be examined. The findings should lead to interventions to decrease the effects of these problematic side effects.

NCT ID: NCT01552655 Completed - Clinical trials for Breast Cancer Recurrent

Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT

BREAC-AUT
Start date: December 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to elucidate the value of dual-time-point PET/CT in the recurrence of breast cancer and to determine whether the method is better than the modalities used in the standard work up. 150 patients with suspected breast cancer recurrence will be included. All patients will undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After completion of the examinations the early and the late PET/CT scan will be compared with each other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained, the presence of recurrence will be verified with additional imaging follow-up to ensure the highest possible confidence. Sensitivity, specificity, accuracy, negative and positive predictive value (NPV/PPV) will be calculated for each modality (incl. early and late PET/CT).

NCT ID: NCT01550848 Completed - Clinical trials for Metastatic Breast Cancer

A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer

Start date: January 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.