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Breast Neoplasms clinical trials

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NCT ID: NCT01952717 Completed - Clinical trials for Breast Cancer Diagnosis

PMA Required Pivotal Multi-reader Multi-case Reader Study

Start date: June 2012
Phase: N/A
Study type: Observational

A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the Pre-market Approval (PMA) of KBCT by the US Food and Drug Administration (FDA).

NCT ID: NCT01951976 Completed - Breast Cancer Clinical Trials

Yoga for Aromatase Inhibitor-associated Joint Pain

Start date: September 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether it might be practical and useful to investigate the effectiveness of yoga classes in relieving joint pain associated with the use of a class of medications known as aromatase inhibitors.

NCT ID: NCT01950182 Completed - Breast Cancer Clinical Trials

Trastuzumab Combined With Chemotherapy or Endocrine Therapy to Treat Metastatic Luminal B2 Breast Cancer

SYSUCC-002
Start date: September 16, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare progression-free survival (PFS) of patients with metastatic Luminal B2 breast cancer subtype randomised to treatment with Trastuzumab Combined With Chemotherapy or Endocrine Therapy.

NCT ID: NCT01949376 Completed - Breast Cancer Clinical Trials

Mild Cognitive Impairment in Breast Cancer Patients

HippoPCI
Start date: June 2013
Phase:
Study type: Observational

The purpose of this study is to improve our understanding of potential changes in size, shape and activity in some brain areas that can occur in women receiving different types of Breast Cancer therapy, and how these changes are related to the development of mild cognitive impairment as the result of these treatments.

NCT ID: NCT01948960 Completed - Breast Neoplasms Clinical Trials

Influence of Exceptional Patient Characteristics on Everolimus Exposure

INPRES
Start date: August 2013
Phase: Phase 4
Study type: Interventional

A study to determine whether everolimus pharmacokinetics in elderly and obese patients is different compared to control patients. Furthermore the investigators will investigate the relation between metabolic response assessed with [18F] Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and everolimus exposure and clinical benefit. The investigators will explore whether dose escalation in patients who are hypothetically underexposed will result in an increase in metabolic response.

NCT ID: NCT01948843 Completed - Clinical trials for HER2 Negative Metastatic Breast Cancer

Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer

Start date: April 2014
Phase: Phase 1
Study type: Interventional

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers that require arginine. In this study, ADI will be combined with the well known chemotherapy Doxorubicin and the safety and potential efficacy of this combination will be explored in patients with HER2 Negative Metastatic Breast Cancer.

NCT ID: NCT01948726 Completed - Clinical trials for Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost

Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Start date: December 2013
Phase: N/A
Study type: Interventional

Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies. Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II according NCI-CTCAE amounts maximum 20%.

NCT ID: NCT01948128 Completed - Breast Cancer Clinical Trials

Effects of Vitamin D in Patients With Breast Cancer

OTT 12-06
Start date: October 2013
Phase: Phase 2
Study type: Interventional

This protocol is a randomized, phase 2 "window of opportunity" trial assessing the biological effects of short term oral vitamin D administration on breast cancer clinical and translational markers in patients awaiting surgery at the Ottawa Hospital. It takes advantage of the current wait times (2-8 weeks) for breast cancer surgery as a "window of opportunity" to rapidly assess biological changes with vitamin D intake.

NCT ID: NCT01945775 Completed - Breast Neoplasms Clinical Trials

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)

EMBRACA
Start date: October 14, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.

NCT ID: NCT01945476 Completed - Breast Cancer Clinical Trials

Effect of Midazolam Premedication Before Induction on the Functional Recovery After General Anesthesia in the Patients Undergoing Breast Surgery Due to Breast Cancer

Start date: September 2013
Phase: N/A
Study type: Interventional

Normally, higher levels of preoperational stress or anxiety affect behavior and recovery after the operation. Moreover, patients undergoing mastectomy are usually young women, and this demographic is known to experience higher levels of stress and anxiety than any other. Anesthetizing patients involves more than just anesthesia in operation; it also includes all of the preoperative treatments for optimizing a patient's condition and promoting quick postoperative recovery. Pharmacological premedication for anxiolysis or amnesia before anesthesia has been a common means of sedation that many studies have investigated. However, such studies have focused on alleviating patients' anxiety and on how far patients can obey induction for sedation; there has been no research on post-operational prognoses, the ultimate purpose of reducing anxiety. The well-known effect of pharmacological premedication is to reduce the capacity of the anesthetic. However, it is not confirmed whether this effect leads to better recovery after anesthesia, as this question has not been researched. Furthermore, recently some have argued strongly that premedication actually prolongs recovery and that it does not need to be applied to every patient. Recently, therefore, the use of pharmacological premedication has been left to the discretion of institutes or doctors in many cases. Among types of premedication, midazolam belongs to the class of short-acting benzodiazepines and is frequently used, as it induces meaningful anterograde amnesia and causes fewer aftereffects such as respiratory problems. In addition, its effects have already been demonstrated. However, research on the improvement of functional health after anesthesia—i.e., patients' quick return to normal life—is still poor and needs to be advanced. When measuring the degree of recovery, recent studies tend to focus on measuring how quickly patients are able to return to normal life rather than the recovery of specific symptoms. To this end, the most widely used method is the Quality of Recovery 40 (QoR-40) survey. It has a total of 40 items, which are classified into five categories: emotional state, physical comfort, psychological support, physical independence, and pain. Questions are answered using a 5-point scale, with 1 being worst and 5 being best. It takes 6.3 minutes on average to complete, and its test-retest reliability, internal consistency, and split-half coefficient have led it to be recognized as the most effective survey method. Moreover, it has been used in many studies investigating how the type of operation, method of anesthesia, additional medication, and gender affect anesthesia and the operation. Its validity for such research has been verified. Therefore, investigators can investigate the degree of postoperational functional recovery through the QoR-40 by comparing cases in which an operation is performed with or without midazolam.