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Breast Cancer clinical trials

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NCT ID: NCT02408406 Active, not recruiting - Breast Carcinoma Clinical Trials

PatientCareAnywhere Internet-Based Software in Improving Communication and Education in Patients With Cancer and Their Healthcare Providers

Start date: July 7, 2015
Phase: N/A
Study type: Interventional

This partially randomized pilot clinical trial develops and studies a software program, called PatientCareAnywhere, to see whether it can help patients communicate with their doctors and other healthcare providers, and educate themselves about their cancer and treatment options. A program that can help patients learn about their cancer and treatment options, and allows the patient's healthcare providers to receive their questionnaire results, may help patients identify and get help to treat their symptoms.

NCT ID: NCT02406599 Active, not recruiting - Breast Cancer Clinical Trials

MarginProbe® System U.S. Post-Approval Study

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

The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery. *A positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface

NCT ID: NCT02401685 Active, not recruiting - Breast Cancer Clinical Trials

POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer

POSNOC
Start date: August 1, 2014
Phase: N/A
Study type: Interventional

POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial. Aim For women with early stage breast cancer and one or two sentinel node macrometastases, to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years. Stratification: Institution, Age (<50, ≥50), Breast-conserving surgery (BCS) or mastectomy, Estrogen receptor (ER) status (positive, negative), Number of positive nodes (1, 2), Intra-operative sentinel assessment using OSNA (yes, no). Interventions The study will compare adjuvant therapy alone with adjuvant therapy plus axillary treatment (axillary node clearance (ANC) or axillary radiotherapy (ART)). Sample Size: 1900 participants Follow-up: Participants will be followed up for 5 years. Adjuvant Therapy: All participants will receive adjuvant systemic therapy (chemotherapy and/or endocrine therapy). All participants may receive breast/chest wall radiotherapy. Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant therapy alone.

NCT ID: NCT02400658 Active, not recruiting - Breast Cancer Clinical Trials

Efficacy of IORT With CT-Guided HDR Brachytherapy for Treatment of Breast Cancer

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

The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.

NCT ID: NCT02393794 Active, not recruiting - Breast Cancer Clinical Trials

Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)

Start date: July 17, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Study combination use of cisplatin plus romidepsin and nivolumab in metastatic triple negative breast cancer (TNBC) or BRCA mutation-associated locally recurrent or metastatic breast cancer

NCT ID: NCT02389842 Active, not recruiting - Breast Cancer Clinical Trials

PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib

PIPA
Start date: March 25, 2015
Phase: Phase 1
Study type: Interventional

Part A: This is a phase Ib trial combining the CDK4/6 inhibitor palbociclib with the PI3K inhibitors taselisib, or pictilisib. There are two treatment arms during the dose escalation phase where patients will receive either taselisib OR pictilisib in combination with palbociclib. Palbociclib, taselisib and pictilisib can all be given orally once daily with food, in a 21-days-on and 7-days-off schedule. Once the MTD is reached, the combination with the optimum safety and PK/PD profile will be taken forward to the dose expansion phase (Part B). Part B1: At the MTD dose expansion, fulvestrant will be administered in addition to palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on and 7-days-off schedule in the ER+ve HER2-ve PIK3CA mutant breast cancer cohort. Fulvestrant will be given intramuscularly on Day 1, Day 15 in cycle one followed by Day 1 for all subsequent cycles. Part B2: At the MTD dose expansion, patients with PIK3CA mutant advanced solid tumours will be treated with palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on and 7-days-off schedule.

NCT ID: NCT02370797 Active, not recruiting - Breast Cancer Clinical Trials

Node Negative, Invasive Breast Cancer Single Fraction IOERT

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

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

NCT ID: NCT02339779 Active, not recruiting - Breast Cancer Clinical Trials

Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy

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

This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT (intervention group) or reconstruction with implants (control group). AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness.

NCT ID: NCT02339532 Active, not recruiting - Breast Cancer Clinical Trials

Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According to TOP2A Status

NeoTOP
Start date: January 2015
Phase: Phase 2
Study type: Interventional

The main objective of this multicenter study will therefore be to evaluate pathologic complete response rates of an anthracycline-based regimen [FEC 100 - TAXOTERE® - HERCEPTIN® - PERTUZUMAB] and a non anthracycline-based regimen [TAXOTERE® - CARBOPLATINE - HERCEPTIN® - PERTUZUMAB] according to the presence or not of TOP2A gene amplification in a population of breast cancer patients with HER2 overexpression. A very important objective of the study will be the evaluation of biomarkers that predict response to treatment.

NCT ID: NCT02338310 Active, not recruiting - Breast Cancer Clinical Trials

Trial of Perioperative Endocrine Therapy - Individualising Care

POETIC
Start date: September 2008
Phase: Phase 3
Study type: Interventional

To determine whether perioperative endocrine therapy with an aromatase inhibitor (AI) followed by standard adjuvant therapy improves outcome compared with standard adjuvant therapy alone in postmenopausal women with hormone receptor positive breast cancer. To determine whether the proliferation marker Ki67 as measured by immunohistochemistry (IHC) in the excised cancer around 2 weeks after starting AI therapy will predict for time to recurrence (TTR) in the individual patient more effectively than the pre-treatment Ki67 value. To determine whether molecular profiling 2 weeks after starting endocrine therapy predicts for long-term outcome in postmenopausal women with hormone receptor positive breast cancer better than at diagnosis.