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Breast Cancer clinical trials

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NCT ID: NCT04591431 Active, not recruiting - Breast Cancer Clinical Trials

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

ROME
Start date: October 7, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, prospective, multicenter, Proof of Concept, Phase II clinical trial Study. The main objective of the study is to evaluate the efficacy (meant as overall response rate ORR) of TT (targeted Therapy) vs SoC (standard of Care) in patients with progressive disease (recurrent and/or metastatic) of breast cancer, metastatic gastro-intestinal tumors, non small cell lung cancer (NSCLC) or others. Patients should have completed at least 1 line of treatment and no more than 2 as defined by the current version of the AIOM (Italian Association of Medical Oncology) guidelines. Patients are included if surgery is contraindicated.

NCT ID: NCT04586517 Active, not recruiting - Clinical trials for Breast Cancer Female

Effect of Heavy-load Resistance Training During Chemotherapy on Muscle Cellular Outcomes

Start date: December 5, 2018
Phase: N/A
Study type: Interventional

(Neo-)adjuvant chemotherapy for breast cancer is known to have a negative impact on muscle tissue resulting in reduced aerobic fitness, skeletal muscle mass and strength. Physical exercise during treatment may counteract some of these negative effects. However, the effects of resistance training alone have never been explored. The present study aims to investigate if heavy-load resistance training during (neo-)adjuvant chemotherapy counteracts negative effects on skeletal muscle in women diagnosed with breast cancer. The hypothesis is that (neo-)adjuvant treatment with chemotherapy will reduce muscle fiber size, impair mitochondrial function and increase indicators of cellular stress and that resistance training during treatment will counteract these negative effects. Fifty women recently diagnosed with breast cancer scheduled to start (neo-)adjuvant chemotherapy will be randomized to either an intervention group or a control group. The intervention group will perform supervised heavy-load resistance training twice a week over the course of chemotherapy (approximately 16-weeks) whereas the control group will be encouraged to continue with their usual activities. To increase interest in participation, controls will be invited to a 2-week introduction to the same resistance-training program as the intervention group following completion of chemotherapy. Muscle biopsies from m. vastus lateralis will be collected before the first cycle of chemotherapy, after chemotherapy, and 6 months later (6-month follow-up) for assessment of muscle cellular outcomes. Results from this intervention will provide further knowledge on how chemotherapy affects muscle tissue and how resistance training may counteract immediate and long-term treatment side effects. Results from this intervention will also contribute with knowledge about how to improve exercise programs that are effective for women undergoing chemotherapy against breast cancer.

NCT ID: NCT04582968 Active, not recruiting - Breast Cancer Clinical Trials

Pyrotinib Combined With Brain Radiotherapy in Breast Cancer Patients With Brain Metastases

Start date: January 2, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. Pyrotinib is an irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor (EGFR)/HER1, HER2, and HER4. This study consists of two parts. In a phase Ib part, investigators will explore the safety and tolerance of Pyrotinib Plus Capecitabine combined with brain radiotherapy. After completing the phase Ib part, investigators will review the data and decide whether this patient is included in before the start of a phase II part. In the phase II part, investigators will evaluate the efficacy of Pyrotinib Plus Capecitabine combined with brain radiotherapy in patients with HER2 positive breast cancer patients with brain metastases.

NCT ID: NCT04574609 Active, not recruiting - Breast Cancer Clinical Trials

Evaluation of the Impact of the Use of Hypnotherapy Performed by a Virtual Reality Toolalong the Care Pathway of Patients Undergoing Breast Cancer Treatment.

HYGEE
Start date: September 24, 2020
Phase: N/A
Study type: Interventional

In 2017, it is estimated that nearly 60,000 new cases of breast cancer will be diagnosed in France. Although several treatments are indicated in this context, chemotherapy remains a curability option whose place today extends to small tumors to support its increasingly approved administration contributing to a continuous increase in survival rates. However, diagnostic procedures and anti-cancer treatments are frequently responsible for toxicity that can reach high levels of severity and even generate sequelae. These physical and psychological after-effects of breast cancer treatment have a short and medium-term impact on the quality of life of the patients treated: anxiety, fear, pain, job loss, and the onset of precariousness. In addition, surgical procedures such as PAC and pic-line surgery are often associated with anxiety and pain. Chemotherapy is particularly associated with anxiety, stress, fatigue, nausea and vomiting. Some immediate, delayed or even anticipated side effects are not always effectively controlled by the medication available to us. Anti-nausea medications can lead to drug interactions and/or other adverse effects. The interest of a non-drug approach is to get rid of these adverse effects. However, it is underestimated and therefore currently not integrated into current practice. Its benefits must therefore be explored within the framework of in-depth research protocols that justify our study.

NCT ID: NCT04574063 Active, not recruiting - Breast Cancer Clinical Trials

PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

PIONEER
Start date: September 16, 2020
Phase: N/A
Study type: Interventional

A randomised controlled trial in which women discharged from the symptomatic breast clinic, who are above population risk (according to Tyrer Cuzick) will be asked to create lifestyle related goals. They will be told their estimated risk of developing breast cancer and will be randomised to one of three interventions: - Breast cancer risk leaflet only - lifestyle website - lifestyle website plus group coaching. Fifty per cent of women will also be randomised to have Single Nucleotide Polymorphisms (SNPs) performed, and these will be incorporated into their risk score. The primary end point will be whether or not women achieve their lifestyle goal.

NCT ID: NCT04553133 Active, not recruiting - Breast Cancer Clinical Trials

PF-07104091 as a Single Agent and in Combination Therapy

Start date: September 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers.

NCT ID: NCT04536584 Active, not recruiting - Clinical trials for Breast Cancer Female

Impact of Personalized and Remote Support Centered on Exercise and Physical Activity for Breast Cancer Patients

Start date: December 18, 2020
Phase: N/A
Study type: Interventional

A study that evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.

NCT ID: NCT04534010 Active, not recruiting - Breast Cancer Clinical Trials

Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

Start date: April 28, 2021
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had autologous breast reconstruction for breast cancer. Secondary objectives will be to assess patient satisfaction, patient well-being, patient self-esteem, patient body image, patient psychological well-being, nipple dimensions and sensitivity following NAC reconstruction surgery with the BioAesthetics' dcl-hNAC graft.

NCT ID: NCT04532177 Active, not recruiting - Breast Cancer Clinical Trials

Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery

SBRT BREAST
Start date: August 19, 2020
Phase: Early Phase 1
Study type: Interventional

This is a prospective pilot study investigating the safety and efficacy of stereotactic body radiation therapy (SBRT) as a treatment for breast cancer in patients who do not get surgery. The study will accrue 15 patients who will be treated to a dose of 40 Gy over the course of 5 fractions in the Stony Brook University Hospital Department of Radiation Oncology. The subjects will then have a follow up time of 5 years.

NCT ID: NCT04527510 Active, not recruiting - Breast Cancer Clinical Trials

Remote Breast Cancer Screening Study

Start date: January 1, 2021
Phase:
Study type: Observational

A multi-center, prospective, cohort study to evaluate the efficiency of breast cancer screening based on Automated Breast Ultrasound (AB US) with remote reading mode.