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Breast Neoplasms 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: 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: NCT02400190 Active, not recruiting - Breast Neoplasms Clinical Trials

The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

Start date: May 27, 2015
Phase: N/A
Study type: Interventional

This study will collect rates of local/regional recurrence in select patients who do not receive radiation treatment after lumpectomy surgery. These women must be postmenopausal; have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal to 18; and plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at sufficiently low risk of local/regional recurrence that omission of adjuvant radiation might be a reasonable option.

NCT ID: NCT02398773 Active, not recruiting - HER2/Neu Negative Clinical Trials

FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy

Start date: May 4, 2016
Phase: Phase 2
Study type: Interventional

This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with newly diagnosed breast cancer that has spread to other parts of the body. FES is a radioactive form of the hormone estrogen and may "light up" where cancer is in the body. Diagnostic procedures using FES, such as FES PET/CT, may help measure the FES and help doctors predict how well the cancer will respond to treatment.

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: NCT02390427 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer

Start date: April 20, 2015
Phase: Phase 1
Study type: Interventional

This research study is a way of gaining new knowledge about the combination of Taselisib with other drugs in the treatment of metastatic breast cancer. Taselisib is an investigational drug which works by blocking a protein called PI3K (phosphoinositide 3-kinase) that helps cancer cells grow. This drug has been used in laboratory experiments and information from these studies suggests that this drug may help to prevent or slow the growth of cancer cells. The main purpose of this study is to find the appropriate dose of Taselisib to be used with other drugs in further clinical studies. This is an open-label, 3+3 dose-escalation phase Ib study to identify the Maximum Tolerated Dose(s) (MTD) and to identify the recommended phase 2 dose (RP2D) of Taselisib. This study will be conducted in 4 separate arms. (A-D).

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: NCT02389699 Active, not recruiting - Breast Neoplasms Clinical Trials

Comparison of Intra-operative Radiotherapy With Post-operative Radiotherapy for Women With Ductal Carcinoma in Situ

Start date: June 2014
Phase: N/A
Study type: Interventional

Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to compare the effectiveness of radiation therapy during surgery and whole-breast radiation therapy in treating women who have undergone breast-conversing surgery for Intermediate or high grade ductal carcinoma in situ breast cancer.

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.