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Breast Diseases clinical trials

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NCT ID: NCT03756064 Recruiting - Breast Cancer Clinical Trials

Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

NCT ID: NCT03730051 Recruiting - Breast Diseases Clinical Trials

Dotarem vs Gadobutrol Contrast for Breast MRI

Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

In this randomized clinical trial, the investigators expect to demonstrate that the MRI contrast agent Dotarem is not less effective in contrast enhancement of breast lesions then Gadavist. Participants will be randomized to receive either Dotarem or Gadavist. In all cases, inclusion criteria will require patients having undergone or scheduled or most likely to be scheduled to undergo tissue sampling with histology results available. The patients will be prospectively and consecutively identified such that the majority of patients included will have been diagnosed with breast cancer, while including benign disease in the minority of patients in each arm. Following randomized enrollment, quantitative, semi-quantitative and qualitative image analysis will be performed to objectively assess for differences in image quality and diagnostic value.

NCT ID: NCT03709446 Recruiting - Breast Neoplasms Clinical Trials

Leflunomide in Previously Treated Metastatic Triple Negative Cancers

Start date: April 16, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Triple negative breast cancer (TNBC) represents about 15% of breast cancers and is characterized by the lack of expression of estrogen receptor (ER), progesterone receptor (PR), and HER-2 non-amplification. Women with TNBC tend to be younger, African American, and BRCA-1 germline carriers. The hallmark of this subtype is early metastatic recurrences with a peak frequency 1-2 years. Prognosis for metastatic TNBC is especially poor with median survival of about 1 year as compared to about 2-4 years with other types of metastatic breast cancer. The primary objective of the phase I part of this study is to determine the safety, tolerability and maximum tolerated dose of leflunomide in women with previously treated TNBC (or ER+ , HER2-neg MBC in Phase I). The primary objective of the phase 2 part of this study is to determine the efficacy of leflunomide in patients with TNBC. Leflunomide, which will be taken daily by mouth, is an inhibitor of dihydroorotate dehydrogenase (DHODH). This proposal will test if DHODH is a novel target for a particular subset of women with metastatic TNBC.

NCT ID: NCT03374826 Recruiting - Breast Cancer Clinical Trials

PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients

Start date: February 22, 2018
Phase: N/A
Study type: Interventional

Axillary lymph node status is an important prognostic factor for patients with breast cancer. After breast cancer diagnosis, current nodal staging consists of axillary ultrasound (US) combined with tissue sampling when deemed necessary. In case of positive axillary lymph nodes, patients will undergo axillary lymph node dissection (ALND). In case of no suspicious axillary lymph nodes (i.e. clinically node negative patients), patients will undergo sentinel lymph node biopsy (SLNB). This surgical nodal staging is accompanied by co-morbidity. In theory, if non-invasive imaging can evaluate the lymph node status accurately, a node negative patient would no longer have to undergo axillary surgery. Since MRI is suitable for soft tissue imaging and PET has the advantage of showing increased metabolic uptake in lymph node metastases, a combination of these techniques in hybrid PET/MRI would be highly desirable. If dedicated axillary hybrid PET/MRI is equally accurate to SLNB for the detection of negative axillary lymph nodes, work-up could be more efficient by bypassing SLNB. However, the accuracy of dedicated axillary hybrid PET/MRI needs to be compared with the pathological outcome of SLNB (gold standard) first.

NCT ID: NCT03019445 Recruiting - Disorders of Breast Clinical Trials

Magseed and Sentimag in Surgical Excision of Breast Lesions

Start date: January 2017
Phase: Phase 4
Study type: Interventional

The goal of this clinical research study is to learn more about the safety and effectiveness of a marker called Magseed that is used to help locate lesions during surgery. The Magseed marker is a small metallic marker (smaller than a grain of rice) that is placed in participant's breast close to or inside the lesion by participant's radiologist.

NCT ID: NCT02929420 Recruiting - Clinical trials for Fibrocystic Disease of Breast

A Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule

Start date: October 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.

NCT ID: NCT02928978 Recruiting - Clinical trials for Ductal Carcinoma In Situ

Ruxolitinib for Premalignant Breast Disease

TBCRC042
Start date: May 13, 2018
Phase: Phase 2
Study type: Interventional

This study is evaluating how ruxolitinib affects premalignant breast cells. One half of the study participants will receive ruxolitinib for approximately 15 days, and the other half will receive a placebo (sugar pill) for approximately 15 days. Once study participants have completed their ruxolitinib or placebo, participants will undergo surgery to remove the premalignant breast tissue.

NCT ID: NCT02511301 Recruiting - Clinical trials for Early-Stage Breast Carcinoma

Circadian Thermal Sensing to Detect Breast Disease

Start date: June 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine if Cyrcadia's Circadian Biometric Recorder (CBR™), which is attached to soft biometric patches worn on the body, can improve early breast cancer detection along with mammography or as a stand alone device.

NCT ID: NCT01937039 Recruiting - Breast Cancer Clinical Trials

Johns Hopkins Breast Cancer Program Longitudinal Repository

Start date: April 2009
Phase:
Study type: Observational

The Breast Cancer Program Longitudinal Repository (BCPLR) is being established to fulfill the research mission of the Breast Cancer Program at Johns Hopkins and to serve investigators affiliated with it - to develop a repository of specimens with corresponding characteristics from patients seen in the breast care and cancer clinics.

NCT ID: NCT01917279 Recruiting - Breast Neoplasms Clinical Trials

Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC

CAMELLIA
Start date: October 2013
Phase: Phase 3
Study type: Interventional

It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast cancer(mBC).