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Breast Cancer clinical trials

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NCT ID: NCT03404752 Recruiting - Breast Cancer Clinical Trials

Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.

Start date: August 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.

NCT ID: NCT03402997 Recruiting - Breast Cancer Clinical Trials

Tissue Resistivity in Breast Cancer Patients

Start date: December 15, 2017
Phase: N/A
Study type: Observational

The resistivity measurements will be done by introducing a needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues.

NCT ID: NCT03402529 Recruiting - Breast Cancer Clinical Trials

Added Value of Contrast Enhanced Spectral Mammography, CESM. A Pilot Study.

Start date: November 28, 2017
Phase: N/A
Study type: Interventional

Introduction: To avoid unnecessary mastectomies and reoperations a correct size assessment of malignant lesions in breast is required. Sometimes a supplementary MRI is therefore recommended. However, at our unit MRI is not easily available. Contrast enhanced spectral mammography (CESM) has in smaller studies been shown to be equal to MRI regarding sensitivity and specificity. Size assessment using contrast-based modalities as CESM has also been shown to be significantly more accurate than using mammography. Prospective randomized studies using CESM are lacking. Aim: The aim of the study is to evaluate the added value of CESM in diagnostics of breast cancer and choice of operation; partial mastectomy or mastectomy. A pilot study of 50 patients will be conducted to prepare for a larger prospective randomized study. Method: Patients found with breast cancer after diagnostics with mammography, ultrasound and core biopsy, and whom are recommended primary surgery, will be enrolled in the study. A supplementary examination with CESM will be performed. Preoperative extent of the malignant lesions are estimated with each modality and is later compared with the extent measured in post-operative PAD. Data on weight, length, age at menopaus, use of contraceptive pills, HRT or endocrine therapy, breast volume and density is collected, as well as data of diagnosis (ductal or lobular carcinoma), surrounding DCIS, histological grade, ER, PgR, Her2 expression and Ki67 index. In this pilot study sensitivity and specificity for each modality is calculated. Multivariate analysis will be performed regarding influential factors. Pearson correlation coefficient will be calculated for each modality regarding size assessment of the malignant lesions in comparison with definitive PAD.

NCT ID: NCT03395899 Recruiting - Breast Cancer Clinical Trials

Pre-operative Immunotherapy Combination Strategies in Breast Cancer

ECLIPSE
Start date: December 21, 2017
Phase: Phase 2
Study type: Interventional

International, open label, window of opportunity phase II trial that aims to evaluate the effects of immunotherapy based treatment combinations in women with untreated, histologically confirmed, operable, ER+, HER2-negative breast cancer.

NCT ID: NCT03394287 Recruiting - Breast Cancer Clinical Trials

A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With Advanced TNBC

Start date: January 10, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase Ib/II, Open-labeled Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib (VEGFR2 inhibitor) in Subjects with Advanced Triple Negative Breast Cancer. Subjects with Triple Negative Breast Cancer will be recruited. The first part of the study is the Dose-finding Phase designed to establish the safety of SHR-1210 Combination With Apatinib at different dose levels(375mg QD or 250mg QD ). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses for each of the 2 cohorts (first cohort for aptinib daily dosing and second cohort for aptinib intermittent dosing ). This study aims to evaluate the efficacy and safety of SHR-1210 combination with apatinib in the treatment of advanced TNBC.

NCT ID: NCT03392233 Recruiting - Breast Cancer Clinical Trials

Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

Start date: August 18, 2017
Phase: Phase 2
Study type: Interventional

Stereotactic Body Radiation Therapy(SBRT) for spinal metastases has been proved a good results in pain relieve and local control, However,the longterm of efficacy and safety of this regimen is unclear.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years.

NCT ID: NCT03391271 Recruiting - Breast Cancer Clinical Trials

PBMT for the Prevention of CIPN

Start date: November 13, 2017
Phase: N/A
Study type: Interventional

ne of the most common cancers in women worldwide is breast cancer. A common used therapy in early-stage and metastatic breast cancer involves chemotherapy. Taxanes, microtubule-targeting agents (MTAs), are one of the most used chemotherapeutic agents in breast cancer patients. Unfortunately, this treatment comes with many unfortunate side effects. Chemotherapy-induced peripheral neuropathy (CIPN) is one of these common side effects. This condition involves paresthesia, numbness and/or burning pain in distal limbs. Eventually, loss of temperature sensation, loss of tendon reflexes and pain sensation can occur. Yet, no therapies have been developed to treat CIPN. At the moment, only symptom management is possible. Not only will this condition affect the patients' daily activities, but a chemotherapy dose reduction could also be necessary, influencing the outcome and overall survival rate of the patient. A new and emerging treatment for CIPN is photobiomodulation therapy (PBMT) or low-level laser therapy. During PBMT, visible and/or (near)-infrared laser light is used at the affected area to improve tissue repair and thereby promote functional recovery of peripheral nerves. Studies have shown positive results for patients with diabetic neuropathy. However, no studies have been undertaken specifically for taxane-induced neuropathy (TIN). We hypothesize that PBMT is an effective treatment strategy to prevent sensory symptoms associated with TIN. This can lead to an improved quality of life for the patient and no need for a chemotherapy dose reduction.

NCT ID: NCT03384511 Recruiting - Breast Cancer Clinical Trials

The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.

Start date: September 30, 2016
Phase: Phase 4
Study type: Interventional

This is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 PET/CT scan can predict the efficacy and adverse events of apatinib in patients with malignancies. Integrin αvβ3 has been shown to play an important role in angiogenesis and up-regulated obviously in various types of tumor cells and activated endothelial cells. The arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high affinity and specificity. The 18F-ALF-NOTA-PRGD2 will highly combine with αvβ3, and thus will monitor the antiangiogenic status.In the current study, investigators propose to evaluate the feasibility of 18F-RGD PET/CT in monitoring efficacy and adverse events of apatinib in malignancies.

NCT ID: NCT03377387 Recruiting - Breast Cancer Clinical Trials

Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer

Start date: December 13, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I study. The purpose of this study is to test the safety of the study drug neratinib in combination with a standard chemotherapy drug called capecitabine at different doses to find out what effects, if any, it has on people. Capecitabine (Xeloda®) is approved by the Food and Drug Administration (FDA) for advanced breast cancer treatment. Neratinib is an investigational drug, meaning the FDA has not approved the use of this drug for advanced breast cancer. The combination of capecitabine and neratinib has been studied before in another study where capecitabine was administered using the standard dosing schedule. In this study, the investigators want to find out if a different dosing schedule of capecitabine combined with neratinib is safer. This different dosing schedule is experimental, meaning the administration schedule of capecitabine and neratinib is not FDA approved for treatment for HER2 positive advanced breast cancer.

NCT ID: NCT03375801 Recruiting - Breast Cancer Clinical Trials

Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment: A Pre- and Post-intervention Study.

BRASA
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

This is a pre-and post intervention study on the effect and implementation of an personalized decision aid for woman with breast cancer who face a decision on their radiation treatment.