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Breast Neoplasms clinical trials

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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: NCT02389764 Terminated - Breast Cancer Clinical Trials

Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC)

Start date: June 22, 2015
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if Ofev® (nintedanib, also called BIBF1120) can help to control IBC. The safety of this drug will also be studied. This is an investigational study. Nintedanib is commercially available and FDA approved for the treatment of certain types of lung disease. Its use in this study is investigational. The study doctor can explain how the study drug is designed to work. Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.

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: NCT02389686 Recruiting - Breast Neoplasms Clinical Trials

Intra-operative Radiotherapy For Breast Cancer Women After NSM

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

The role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to assess the value of the INTRABEAM system for breast cancer.

NCT ID: NCT02389673 Recruiting - Breast Neoplasms Clinical Trials

Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer

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

Whether the patients with low grade ductal carcinoma in situ breast cancer should accept radiationtherapy is uncertain.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 find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

NCT ID: NCT02387099 Completed - Breast Cancer Clinical Trials

Dose EScalation Induction of EvERolimus

Desiree
Start date: May 2015
Phase: Phase 2
Study type: Interventional

The BOLERO-2 study demonstrated a benefit for patients who received everolimus in addition to exemestane in patients who progressed during/after a non-steroidal aromatase inhibitor; Routine use of everolimus shows an high rate of intolerability due to mucositis/stomatitis especially during the first 12 weeks of treatment leading cause for treatment discontinuation not related to tumor progression; GeparQuinto study (setting III: non-responders): everolimus was given as salvage treatment in combination with paclitaxel for patients without response to 4 cycles epirubicin/cyclophosphamide with/without bevacizumab. A dose-escalation schema was successfully used to improve tolerability of everolimus together with the cytotoxic Agent. Everolimus plus exemestane has improved the prognosis of metastatic breast cancer significantly. Desiree-study aims to improve the tolerability, which is necessary in order to achieve an adequate dose intensity for the patients in Routine care.

NCT ID: NCT02386371 Completed - Breast Carcinoma Clinical Trials

Intraoperative Radiotherapy After Local Recurrence in Breast Cancer

RE-IORT01
Start date: March 2014
Phase: N/A
Study type: Interventional

The investigators propose a prospective, multicenter, single arm Phase II design to evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.

NCT ID: NCT02386176 Completed - Breast Cancer Clinical Trials

Assessment of Automated Breast Ultrasound

Start date: August 2015
Phase:
Study type: Observational

The investigators are interested in assessing the value of and comparing the use of automated breast ultrasound (ABUS) (either as a primary screening approach or as a supplementary procedure) with digital breast tomosynthesis (DBT). The purpose of this project is to perform a preliminary prospective study on women who are most likely to benefit from the use of ABUS and/or DBT (or a combination of both) in the screening environment.

NCT ID: NCT02384746 Terminated - Breast Cancer Clinical Trials

Phase I Study of the Combination of MLN9708 and Fulvestrant

Millennium
Start date: June 2, 2015
Phase: Phase 1
Study type: Interventional

Participants in this study will have been diagnosed with advanced breast cancer that has become worse while being treated with fulvestrant. Participants will have estrogen-receptor positive disease, and have completed menopause. There is information from research labs which suggests that drugs that work like MLN9708 help kill breast cancer cells that have been treated with fulvestrant. The purpose of the study is to determine the proper dose as well as the good and bad effects of MLN9708 when it is given in combination with fulvestrant. The Investigators also want to learn more about how the drug combination affects tumor cells. The amount of MLN9708 participants receive will be determined by when they enter this study. Three different doses will be given to different participants. The Investigators expect to enroll a total of 12-18 people.

NCT ID: NCT02384239 Completed - Clinical trials for Metastatic Breast Cancer

A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

Start date: October 19, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant or tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving palbociclib together with fulvestrant or tamoxifen citrate may work better in treating hormone receptor positive breast cancer.