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Breast Neoplasms clinical trials

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NCT ID: NCT02677857 Terminated - Breast Cancer Clinical Trials

Developing a Healthy Lifestyle in Breast Cancer Survivors

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

At this time, no study has examined the effect of a lifestyle intervention with a reduced Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with University of Tennessee Medical Center's (UTMC) Cancer Institute, investigators propose to randomize 30 female breast cancer survivors (history of breast cancer stages I [> 1 cm], II, or III) with a body mass index (BMI) between 25 and 45 kg/m2 who are sedentary (engage in > 8 hours a day of SB) and inactive (engage in < 100 min/wk MVPA) to one of three, 3-month conditions: 1. lifestyle intervention (Lifestyle) (increase MVPA to > 200 min/wk); 2. lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to > 200 min/wk and reduce SB by 2 hrs/day); or 3. weight management education materials provided via mailed newsletter (Newsletter). Lifestyle and Lifestyle+SB will receive a standard dietary (low-calorie [1200-1500 kcal/day], low-fat [<30% calories from fat]) prescription that emphasizes intake of fruits, vegetables, and whole grains, and a cognitive behavioral intervention to assist with meeting activity and diet goals. Dependent variables, measured at 0 and 3 months, include objectively measured SB, LPA, MVPA, and total activity via accelerometry; self-reported SB; percent weight loss; insulin and glucose, and leptin and C-reactive protein (CRP) (biomarkers of cancer prognosis that have been found to be positively related to SB and/or adiposity); diet; body composition; and fitness.

NCT ID: NCT02677714 Terminated - Breast Cancer Clinical Trials

99mTc-rhAnnexin V-128 Imaging and Cardiotoxicity in Patients With Early Breast Cancer

Start date: November 2, 2016
Phase: Phase 2
Study type: Interventional

This was a single center, proof-of-concept (PoC), Phase II study. Patients with histologically confirmed early stage (Stage I, II or III) HER-2 negative breast cancer and scheduled to receive doxorubicin-based (neo)adjuvant therapy to be followed by paclitaxel or docetaxel as per clinical practice. The planned doxorubicin-based chemotherapy treatment consisted of doxorubicin 60 mg/m2 in combination with cyclophosphamide 600 mg/m2 (AC) intravenous (IV) every 2 or 3 weeks for 4 cycles. Patients were scheduled for CMRI and 99mTc-rhAnnexin V-128 imaging (planar and SPECT / CT) at the following visits: 1. Screening/baseline, i.e. 2 weeks prior to initiating AC treatment (Visit 1) 2. After the 2nd and before the 3rd cycle of AC treatment (Visit 2) 3. After the 4th cycle of AC treatment and within 2 weeks (Visit 3) 4. At 12 weeks after the 4th cycle of AC treatment (Visit 4). The imaging procedures were conducted and analyzed. Bloodwork for cardiotoxicity biomarkers (troponin, N terminal pro B-type natriuretic peptide [NT-proBNP]) was performed at each visit.

NCT ID: NCT02677389 Completed - Clinical trials for Stage IIIA Breast Cancer

Survivorship Care Plan in Promoting Physical Activity in Breast or Colorectal Cancer Survivors in Wisconsin

Start date: July 1, 2016
Phase: N/A
Study type: Interventional

This randomized pilot clinical trial studies how well survivorship care plan works in promoting technology-based physical activity in breast or colorectal cancer survivors in Wisconsin. A survivorship care plan may help doctors to better understand how they can help people who have been diagnosed with cancer to become more physically active. It is not yet known whether a standardized cancer survivor plan used as part of routine care or a technology-based physical activity intervention is better in promoting physical activity in breast or colorectal cancer survivors.

NCT ID: NCT02676986 Active, not recruiting - Clinical trials for Primary Breast Cancer ER+ve

Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer

ARB
Start date: August 2015
Phase: Phase 2
Study type: Interventional

Open-label, international, multicentre window of opportunity phase II trial to evaluate the effects of short-term preoperative therapy with enzalutamide (alone or in combination with exemestane) in women with newly diagnosed invasive primary breast cancer. The study has two cohorts: - ER+ve breast cancer - AR+ve, Triple-negative (i.e. ER-negative, PR-negative and HER2-negative) breast cancer Study treatment is planned for a minimum of 15 days and a maximum of 29 days unless there is evidence of unacceptable toxicity or the patient requests to be withdrawn from the trial. Thereafter, patients will either be considered for definitive surgery or primary medical treatment (e.g. neoadjuvant chemotherapy) at the discretion of the treating physician. The effects of enzalutamide (alone or in combination with exemestane) will be assessed on tumour tissue specimens taken at baseline and on the last day of study treatment.

NCT ID: NCT02676531 Completed - Breast Cancer Clinical Trials

Walking Meditation Exercise in Breast Cancer Patients

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

This study is to evaluate the effects of Walking Meditation on vascular function in breast cancer patients receiving Anthracyclines chemotherapy

NCT ID: NCT02675231 Completed - Clinical trials for HER-2 Positive Breast Cancer

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

monarcHER
Start date: May 23, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

NCT ID: NCT02674204 Terminated - Breast Cancer Clinical Trials

STOP Heart Disease in Breast Cancer Survivors Trial

STOP
Start date: May 5, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients.

NCT ID: NCT02673918 Completed - Breast Cancer Clinical Trials

The Breast Cancer Online Rehabilitation Program

BRECOR
Start date: February 2016
Phase: N/A
Study type: Interventional

The investigators have developed an online rehabilitation platform to guide women in their home-based upper-body exercises after breast cancer surgery. The platform includes rehabilitation videos that will guide the women in performing home-based early post-surgery upper-body rehabilitation tailored for each individual. The primary objective is to assess the feasibility and acceptability of a home-based rehabilitation program supported by a supplemental online platform for women after breast cancer surgery before conducting a larger pragmatic trial in the future. The feasibility of the platform will be tested in 11 municipalities in Denmark.

NCT ID: NCT02673398 Completed - Clinical trials for Stage IV Breast Cancer AJCC v6 and v7

Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer

Start date: December 2, 2016
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects of and how well neratinib works in treating older patients with stage IV HER2-positive breast cancer. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT02672475 Completed - Clinical trials for Stage IV Breast Cancer

Galunisertib and Paclitaxel in Treating Patients With Metastatic Androgen Receptor Negative (AR-) Triple Negative Breast Cancer

Start date: March 2016
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of Galunisertib when given together with paclitaxel in treating patients with androgen receptor negative or triple negative breast cancer that has spread to other places in the body. Some tumors need growth factors, which are made by the body's white blood cells, to keep growing. Galunisertib may interfere with growth factors and help cause tumor cells to die. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Galunisertib together with paclitaxel may kill more tumor cells.