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Breast Cancer clinical trials

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NCT ID: NCT02225470 Completed - Breast Cancer Clinical Trials

Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

Start date: September 26, 2013
Phase: Phase 3
Study type: Interventional

This study is designed as an open-label randomized parallel two-arm multicenter efficacy, pharmacokinetics and safety study of intravenously administered eribulin versus intravenously administered vinorelbine in Chinese population. Eligible female subjects will have measurable disease according to RECIST 1.1 with the modification that chest x-ray cannot be used for assessment of disease.

NCT ID: NCT02224807 Completed - Breast Cancer Clinical Trials

Effects of Diet and Exercise on Ductal Carcinoma in Situ

DCIS
Start date: July 2014
Phase: N/A
Study type: Interventional

This pilot/feasibility trial seeks to explore whether an acute bout of negative energy balance prior to surgery affects biomarkers of neoplasia. Forty overweight or obese postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage breast cancer (Stage I or II) who elect mastectomy or lumpectomy will be randomly assigned to 1-of-2 study arms: 1) an Attention Control Group that receives instruction on dietary approaches to correct nutritional deficiencies and progressive resistance training (PRT) that targets the arm ipsilateral to the affected breast; or 2) an Experimental Group that will receive PRT and guidance to correct nutritional deficiencies plus an intensive intervention to promote a 1.5-2 pound/week weight loss through diet, exercise, and behavior modification. This study will explore and contrast changes in body mass index (BMI) observed from enrollment to the time of surgery in the experimental vs. attention control arms, and also monitor changes in energy intake and physical activity. These changes will be studied in relation to the following endpoints: a) changes in select circulating biomarkers and gene expression related to cancer progression, hormonal status, inflammation and other energy-related factors; b) rates of tumor proliferation and apoptosis; c) tumor markers, e.g., insulin receptor, Vascular Epithelial Growth Factor (VEGF), Nuclear Factor kappa beta (NFkB), and phosphoproteins associated with the Convergence of Hormones, Inflammation and Energy-Rated Factors (CHIEF) pathway; and d) functional and health-related outcomes. Because both tumor tissue and blood will be examined from pre-to-post-intervention, this study will provide exciting new data that can elucidate pathways by which energy balance affects breast cancer progression. Although longer term weight loss is recommended for overweight and obese breast cancer survivors, it is not known whether placing the body in a state of negative energy balance will have a favorable impact on the tumor. If beneficial changes in tumor biology and the host environment occur with short-term, pre-surgical weight loss, this study provides proof of concept that weight loss may offer an acceptable and complementary treatment option that could be combined with standard therapies.

NCT ID: NCT02223091 Completed - Breast-cancer Clinical Trials

KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study

KOKON-AS
Start date: September 2014
Phase: N/A
Study type: Interventional

The aim of the study is to investigate the effect of a consultation training program for physicians on the quality of their consultations of breast cancer patients regarding complementary medicine. We assume that the training program might enhance the communication of relevant information, empathy of the physicians or satisfaction with the consultation.

NCT ID: NCT02223052 Completed - Breast Cancer Clinical Trials

Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

Start date: October 27, 2014
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy. Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate in this study.

NCT ID: NCT02222337 Completed - Breast Cancer Clinical Trials

Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers

Start date: May 2013
Phase: N/A
Study type: Interventional

Latina breast cancer survivors report lower quality of life (QOL) than non-Latina survivors. Lower QOL can lead to poorer functional and cancer-related survival outcomes. The friends and family of Latina cancer patients are also impacted by a loved one's diagnosis of breast cancer. Through strong community-academic partnerships, the investigators seek to improve the QOL of Latina survivors and their caregivers with a culturally-relevant intervention. In this project, the investigators plan to further develop and refine the intervention and then test it through a randomized controlled trial. First, the investigators will conduct in-depth qualitative interviews with 10 survivor-caregiver dyads (pairs) to see if the intervention fits for survivors and caregivers in different parts of the country. Then, the investigators will revise the intervention. Finally, the investigators will test the intervention in a randomized controlled trial. The investigators will invite 125 survivor-caregiver dyads to be a part of our study. Half will be asked to complete the intervention and half will be offered the usual services, such as support groups. The information learned from this study could help improve the quality of life in Latina breast cancer survivors and their caregivers. Physicians, survivors, and community groups can also benefit from this study because they will have more information about the needs of Latina breast cancer survivors. The investigators hope to use the information to help other types of survivors and caregivers in the future.

NCT ID: NCT02222259 Completed - Breast Cancer Clinical Trials

A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients

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

The purpose of this study is to determine the feasibility of implementing a randomized controlled study of the intervention (Geriatric Assessment followed by an integrated care plan carried out by the multidisciplinary geriatric oncology team) designed to maintain/improve quality of life and functional status in older adults with advanced gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy. Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer treatment decision of the cancer specialist.

NCT ID: NCT02217891 Completed - Breast Cancer Clinical Trials

IFACT: Incidental Findings in Advanced Cancer Therapy

IFACT
Start date: August 2014
Phase:
Study type: Observational

The proposed study, IFACT - Incidental Findings in Advanced Cancer Therapy, will address this research gap by examining MSK patients' attitudes, preferences, and information needs regarding incidental findings arising from tumor genomic profiling.

NCT ID: NCT02216162 Completed - Breast Cancer Clinical Trials

PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program

PROACTIVE
Start date: April 11, 2014
Phase: N/A
Study type: Interventional

PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric intervention on treatment compliance, measured regularly by blood dosing of drug metabolites. Patients in the intervention group will be proposed: - A regular geriatric follow up including an attentive screening of joint symptoms and functionality, - An adapted treatment of join pain, - Weekly sessions of adapted physical activity (Taï Chi), - And a systematic correction of vitamin D deficits.

NCT ID: NCT02216136 Completed - Breast Cancer Clinical Trials

Tumor: Breast Ratio Study

T:B
Start date: April 14, 2014
Phase:
Study type: Observational

This is an observational study of 3 arms: breast conservation therapy, mastectomy and reconstruction, and mastectomy only.

NCT ID: NCT02212834 Completed - Breast Cancer Clinical Trials

Surveillance Imaging Modalities for Breast Cancer Assessment

SIMBA
Start date: October 2013
Phase:
Study type: Observational

The purpose of this study is to determine the effectiveness of surveillance breast MRI compared to mammography alone in women with a personal history of breast cancer