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Breast Neoplasms clinical trials

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NCT ID: NCT02792101 Not yet recruiting - Breast Neoplasms Clinical Trials

RISAS Procedure in Node Positive Breast Cancer Following NAC

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

Chemotherapy in clinically node positive breast cancer patients is increasingly administrated in a neoadjuvant setting. The standard treatment regimen in these cases is then: neoadjuvant chemotherapy (NAC) followed by breast surgery and an axillary lymph node dissection (ALND). NAC results in axillary pathologic complete response (pCR) in 1 out of 3 patients, indicating a complete absence of axillary metastases after completion of NAC. In such events, ALND can be regarded as overtreatment that creates unnecessary morbidity. Less invasive axillary surgery which can accurately assess axillary pCR is therefore preferred over standard ALND in all patients. In case of detection of remaining axillary lymph node metastases by this less invasive axillary surgical procedure, completion axillary treatment is standard of care. The novel RISAS procedure is introduced as a possible less invasive axillary staging procedure. RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure. The iodine seed in the axillary lymph node metastasis will be placed prior to start of NAC.

NCT ID: NCT02686918 Not yet recruiting - Breast Neoplasms Clinical Trials

Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse

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

The main of this study is to assess the feasibility of a patients follow-up visit receiving trastuzumab subcutaneous by Advanced Practice Nurse.

NCT ID: NCT02685657 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

Neoadjuvant Chemotherapy Docetaxel With or Without SELUMETINIB in Patients With Triple Negative Breast Cancer

Start date: September 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to increase survival of patients with early and locally advanced triple-negative breast cancer adding selumatinib to standard preoperative chemotherapy regimen.

NCT ID: NCT02679638 Not yet recruiting - Breast Cancer Clinical Trials

Factors and Perceptions Affecting Treatment Choices of Breast Cancer Patients

Start date: February 2016
Phase: N/A
Study type: Observational

A Multi-center Cross-sectional quantitative study with a preliminary qualitative study part aiming to identify and analyze demand factors, supply factors and perceptions affecting Breast Cancer patients' treatment choices of Breast Cancer patients in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice. 25 patients and caregivers will participate in the qualitative part and 425 Israeli Breast Cancer patients will participate in the quantitative study.

NCT ID: NCT02670668 Not yet recruiting - Breast Cancer Clinical Trials

Mutation of BRCA1/2 and Other Potential Genes in Triple-negative Breast Cancer

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

The study is to determine the prevalence of potential chemo-response related genes mutation in TNBC patients between pCR and SD/PD group, which achieved after NAC; and to evaluate potential relationship between these gene mutations and NAC-response in TNBC patients.Based on the results,we can further characterize TNBC from a phenotypical and molecular perspective, in order to identify potential new target agents and to individualize the treatment.

NCT ID: NCT02627313 Not yet recruiting - Breast Neoplasms Clinical Trials

Tumor Bed Dose Delivery Using A Breast Specific Radiosurgery Device, The Gammapod: (A Clinical Feasibility Study)

Start date: January 2021
Phase: N/A
Study type: Interventional

Conventional breast radiotherapy is delivered to the entirety of the breast in fractionated treatments given over several weeks. While these techniques are effective, there is a risk of late adverse events from irradiation of surrounding normal tissues and the protracted nature of the treatments is inconvenient to patients and resource-intensive for health care systems. There is an unmet need for novel treatments that can be delivered more quickly, with reduced normal tissue exposure, and without compromising efficacy. The GammaPod is a breast-specific radiotherapy delivery device that holds the promise in addressing these needs. Employing the engineering and physics principles from stereotactic radiotherapy, it allows delivery of a highly-localized radiation dose to a very limited volume of breast. The Ottawa Hospital is the only Canadian member of a consortium of five academic institutions that have acquired the GammaPod in order to rigorously evaluate its use in clinical trials. The aim of the current project is to complete a mandatory clinical feasibility study of the GammaPod as part of the application for Investigational Testing of Medical Devices from Health Canada. The study will focus on the use of the GammaPod to deliver a radiotherapy boost, that is, a localized dose of radiation just around the surgical bed, in a single treatment.

NCT ID: NCT02617264 Not yet recruiting - Breast Cancer Clinical Trials

Spot tm Tattooing of Biopsied Axillary Lymph Nodes With Ultrasound Guided in Breast Cancer Patients Prior to Surgery

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

To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot at time of biopsy.

NCT ID: NCT02612870 Not yet recruiting - Breast Neoplasms Clinical Trials

Sienna+® Injection Time Study 4 Arms

Sentimag02
Start date: February 2016
Phase: Phase 4
Study type: Interventional

Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1 day before surgery, which enables the surgeon to localize the sentinel lymph node during surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes either 1 or 4-6 days before surgery to investigate the concordance with the standard technique.

NCT ID: NCT02583204 Not yet recruiting - Breast Cancer Clinical Trials

Taxane Chemotherapy and Nail Toxicity in Women With Breast Cancer; Stage Two: Evaluation of Interventions

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

The study compares three strategies to prevent/minimise nail problems occuring in women, with breast cancer, undergoing Taxane chemotherapy. The strategies are: application of nail polish and normal care; application of Onicolife drops and normal care and; normal care only.

NCT ID: NCT02544243 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

Start date: September 2015
Phase: Phase 2
Study type: Interventional

Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective. Study Design: Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks