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Malignant Neoplasm of Breast clinical trials

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NCT ID: NCT03435952 Active, not recruiting - Clinical trials for Malignant Neoplasm of Breast

Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT

Start date: July 10, 2018
Phase: Phase 1
Study type: Interventional

Some tumors are difficult to treat with chemotherapy or radiation. One of the reasons is that areas of the tumor do not have many blood vessels, which makes it difficult for drugs to reach those areas. One way that researchers have recently tried to overcome this problem is by injecting special kinds of bacteria into the tumors. These bacteria have been genetically changed to remove the chemicals that are poisonous to humans, but are still able to cause tumor cells to break down and die. The idea is that these bacteria may be able to assist chemotherapy drugs in fighting cancer. The goal of this clinical research study is to find the highest tolerable dose of one of these bacterial therapies (Clostridium novyi-NT spores) that can be given in combination with pembrolizumab to patients with advanced solid tumors. The safety of this drug will also be studied, as well as whether it can help to control the disease. This is an investigational study. Clostridium novyi-NT is not FDA approved or commercially available. It is currently being used for research purposes only. Pembrolizumab is FDA approved for the treatment of melanoma and different types of head and neck and non-small cell lung cancers. It is investigational to use these drugs in combination with each other in various types of advanced cancers. The study doctor can describe how the study drugs are designed to work. Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.

NCT ID: NCT03429907 Active, not recruiting - Clinical trials for Malignant Neoplasm of Breast

An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer

Start date: December 5, 2017
Phase: N/A
Study type: Interventional

The goal of this research study is to learn if starting a stress-reduction program before treatment can affect your stress, mood, and physical symptoms during and after treatment for cancer. This is an investigational study. Up to 140 participants will be enrolled in this study. All participants will be recruited at MD Anderson.

NCT ID: NCT03425656 Completed - Clinical trials for Malignant Neoplasm of Breast

Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer

Start date: July 9, 2016
Phase: Phase 3
Study type: Interventional

This is A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study to evaluate efficacy and safety of AryoTrust (Aryogen Trastuzumab in comparison to Herceptin® (Genentech/Roche) in patients with Human Epidermal Growth Factor Receptor 2-Positive breast cancer. The main objective is to verify the non-inferiority of AryoTrust (Aryogen trastuzumab) vs. Herceptin® (Genentech/Roche trastuzumab), both given concomitantly with docetaxel after doxorubicin plus cyclophosphamide in the neoadjuvant setting according to pathological complete response (pCR) as primary objective and objective response (cOR), clinical complete response (cCR), clinical partial response (cPR), clinical stable disease (cSD), clinical progressive disease (cPD), breast conservation rate as Secondary objectives of this study. Evaluating the safety and immunogenicity of AryoTrust vs. Herceptin®, are also the other secondary outcomes. This study has two arms and 108 subjects will participate with a 1:1 allocation and receive mentioned treatment randomly.

NCT ID: NCT03379428 Active, not recruiting - Breast Neoplasms Clinical Trials

Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer

Start date: November 29, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II, open-label dose-escalation study designed to evaluate the maximum tolerated dose (MTD) and dose-limiting side effects of ibrutinib (560 or 840 or 420 mg daily oral dose), given in combination with trastuzumab administered through the vein, in patients with HER2-amplified Metastatic Breast Cancer that has gotten worse after prior therapy with ado-trastuzumab emtansine (T-DM1).

NCT ID: NCT03366428 Completed - Clinical trials for Malignant Neoplasm of Breast

Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer

Start date: December 26, 2017
Phase: Phase 1
Study type: Interventional

This study will look at the effect on the QTc interval and pharmacokinetics after multiple dosing in subjects with HER2-expressing metastatic and/or unresectable breast cancer.

NCT ID: NCT03289819 Completed - Clinical trials for Malignant Neoplasm of Breast

Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC

NIB
Start date: March 23, 2018
Phase: Phase 2
Study type: Interventional

Despite its aggressiveness and high incidence, to date, no targeted therapies exist for the treatment of triple negative breast cancer (TNBC). Emerging evidence suggests a crucial role of tumor immunology on outcome for this entity. Checkpoint inhibitors like pembrolizumab, which target immune cells within the tumor, might therefore have an important impact on therapy response and outcome in these high risk patients. We propose a phase II study exploring pathological complete response and the safety of the combination of pembrolizumab and nab-paclitaxel as well as the combination of pembrolizumab with epirubicin and cyclophosphamide in the neoadjuvant setting for women with early TNBC. After completion of this study an extension will be determined.

NCT ID: NCT03261323 Withdrawn - Breast Cancer Clinical Trials

Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Start date: May 31, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to: 1. Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs 2. Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications

NCT ID: NCT03162627 Active, not recruiting - Clinical trials for Malignant Neoplasm of Breast

Selumetinib and Olaparib in Solid Tumors

Start date: August 4, 2017
Phase: Phase 1
Study type: Interventional

This study has 2 phases: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 of this clinical research study is to find the highest tolerable dose combination of selumetinib and olaparib that can be given to patients who have solid tumors that are advanced or recurrent (has returned after treatment). The goal of Phase 2 is to learn if the highest tolerable dose combination found in Phase 1 can help to control advanced or recurrent solid tumors. The safety of the study drug combination will also be studied in both parts. This is an investigational study. Selumetinib is not FDA approved or commercially available. It is currently being used for research purposes only. Olaparib is FDA approved and commercially available for the treatment of ovarian cancer that has a certain type of genetic mutation (change). It is considered investigational to use selumetinib in combination with olaparib to treat advanced or recurrent cancer. The study doctor can explain how the study drugs are designed to work. Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.

NCT ID: NCT03159195 Completed - Clinical trials for Malignant Neoplasm of Breast

Ibrance Real World Insights

IRIS
Start date: June 12, 2017
Phase:
Study type: Observational

To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries.

NCT ID: NCT02915172 Withdrawn - Advanced Cancer Clinical Trials

Lenvatinib and Capecitabine in Patients With Advanced Malignancies

Start date: December 2016
Phase: Phase 1
Study type: Interventional

There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of lenvatinib and Xeloda (capecitabine) that can be given to patients with advanced cancer. The goal of Phase 2 of this study is to learn if the dose of lenvatinib and capecitabine found in Phase 1 can help to control advanced cancer. The safety of this drug combination will be studied in both phases of the study.