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Breast Neoplasms clinical trials

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NCT ID: NCT02574507 Completed - Breast Cancer Clinical Trials

Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners

Start date: October 2015
Phase: N/A
Study type: Interventional

The objective of the study is to develop and test the feasibility, acceptability, and initial efficacy of a novel couples-based behavioral weight and symptom management intervention for obese breast cancer survivors and their partners. The proposed project consists of two phases. Phase I will include intervention development and refinement. Intervention development will be guided by the research team's prior work, the interdependence model of communal coping and behavior change, and information obtained from couples participating in focus groups. The intervention protocol will then be tested with 5 couples to assist with refinement of intervention content. During phase II, the feasibility, acceptability and initial efficacy of the intervention will be examined. Obese breast cancer survivors in the three years following treatment and their overweight or obese partners will receive 6 weekly and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The intervention will be provided in a couples-based format where each couple will meet separately with the therapist. Couples will be assessed at pre-, post-, and 3-months post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e., insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer survivors and their partners. It is hypothesized that the intervention will be feasible (i.e., completed sessions), and participants will find the intervention acceptable as assessed by a measure of treatment acceptability. It is also hypothesized that participants will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity, and their change in weight will covary with change in symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that participants with greater weight loss will evidence improved functioning in insulin, IL-6, IL-8, TNF-α, adiponectin, and heart rate.

NCT ID: NCT02574455 Completed - Breast Cancer Clinical Trials

Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)

ASCENT
Start date: November 7, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.

NCT ID: NCT02569294 Completed - Breast Cancer Clinical Trials

Feasibility and Impact of Group Interventions on Breast Cancer Patients Well-being

GIBC
Start date: January 2013
Phase: N/A
Study type: Interventional

This is a clinical non-randomized prospective study. This study had two objectives. The fist one was to determine the interest of breast cancer patients in participating in one of three group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate, the reasons for choosing a particular group or decline the offer. The second objective was to evaluate and compare the benefits of these three interventions on emotional distress, QoL, sleep quality and mental adjustment to cancer, at three times after the end of the interventions (just after the end, at a 3-month and at a 9-month follow-up).

NCT ID: NCT02567929 Completed - Breast Cancer Clinical Trials

Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer

Start date: March 2016
Phase: N/A
Study type: Interventional

Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence. The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.

NCT ID: NCT02566408 Completed - Clinical trials for Stage IIIA Breast Cancer

Attitudes, Beliefs, and Preferences of Older Stage I-III Breast Cancer Survivors Towards Physical Activity

Start date: October 14, 2015
Phase: N/A
Study type: Interventional

This clinical trial studies the attitudes, beliefs, and preferences of older stage I-III breast cancer survivors towards physical activity. Studies have shown that older African-American and women of lower socioeconomic status are more likely than their Caucasian counterparts and women of higher socioeconomic status to have functional disability at the time of a new breast cancer diagnosis. Functional disability is the inability to independently complete activities of daily living and increases health care costs and deaths. The poor health status of older African-Americans with breast cancer has been suggested to diminish the long-term benefits from cancer treatment, resulting in older African-American women more likely to die from breast cancer compared to Caucasians. Questionnaires that measure the attitudes, beliefs, and preferences of older breast cancer survivors may lead to the development of an intervention that increases physical activity, improves functional and health status, and improves breast cancer treatment benefits translating to improved survival among older breast cancer survivors in general, and in particular among older African-American and lower socioeconomic status women with breast cancer.

NCT ID: NCT02565758 Completed - Clinical trials for Advanced Solid Tumors

ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

Start date: September 18, 2015
Phase: Phase 1
Study type: Interventional

This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.

NCT ID: NCT02563925 Completed - Clinical trials for Metastatic Breast Cancer

Brain Irradiation and Tremelimumab in Metastatic Breast Cancer

Start date: September 18, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to see if the combination of tremelimumab and durvalumab with brain radiation therapy can help treat this type of breast cancer that has spread to the brain.

NCT ID: NCT02562378 Completed - Breast Cancer Clinical Trials

T-DM1 and Non-pegylated Liposomal Doxorubicin in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

THELMA
Start date: October 2015
Phase: Phase 1
Study type: Interventional

The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and trastuzumab-based therapy. In addition, pharmacokinetic data on the combination of T-DM1 and liposomal doxorubicin will be obtained.

NCT ID: NCT02561468 Completed - Breast Neoplasm Clinical Trials

The Preemptive Analgesic Efficacy of Nefopam

Start date: April 2015
Phase: N/A
Study type: Interventional

Nefopam is administered as a preemptive analgesic drug to the patient undergoing breast cancer surgery. It will be evaluated whether postoperative acute and chronic pain can be reduced.

NCT ID: NCT02560662 Completed - Breast Cancer Clinical Trials

PhysSurg-B : Physical Activity in Relation to Surgical Operations - Breast Cancer

PhysSurg-B
Start date: January 27, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether a training program with intensified physical exercise prior to and after surgery for breast cancer enhances postoperative recovery.