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Breast Neoplasms clinical trials

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NCT ID: NCT01840306 Completed - Breast Cancer Clinical Trials

Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer

Start date: October 12, 2012
Phase:
Study type: Observational

Primary Objective: (i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for the existence of RNAs/proteins identified in (i) and (ii). Secondary Objective: To develop a predictive model for use in the HER2 positive population based on the most accurate and sensitive combination of the identified biomarkers.

NCT ID: NCT01840163 Completed - Breast Cancer Clinical Trials

A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool

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

This study examines the impact of an online decision tool for patients with early stage invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas. Participants will be randomized to receive either a basic version of a decision tool (similar to existing website with breast cancer information) or an enhanced version (featuring a knowledge building component, a values clarification exercise, and a patient activation module). Our hypothesis is that patients who use the enhanced version of the tool will have greater knowledge of their test and treatment options, have a higher rate of high quality (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the decision-making process.

NCT ID: NCT01839838 Completed - Clinical trials for Stage IA-IIA Breast Cancer

APBI Proton Feasibility and Phase II Study

Start date: April 22, 2013
Phase: N/A
Study type: Interventional

The overall objectives of the study are to establish feasibility and acute side effects of accelerated partial breast irradiation therapy, along with more long-term side effects and clinical efficacy of treatment.

NCT ID: NCT01837602 Completed - Clinical trials for Metastatic Breast Cancer

cMet CAR RNA T Cells Targeting Breast Cancer

Start date: April 2013
Phase: Phase 1
Study type: Interventional

An open-label, clinical trial of autologous cMet redirected T cells administered intratumorally (IT) in patients with breast cancer. Fifteen evaluable patients will be enrolled in stepwise fashion. Step 1 will enroll patients with metastatic breast cancer refractory to at least 1 standard therapy, step 2 will include newly diagnosed patients with operable triple negative breast cancer.

NCT ID: NCT01837147 Completed - Breast Cancer Clinical Trials

Using Technology to Improve Physical Activity Levels Among Postmenopausal Women (The Active & Aware Study)

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

Women who are overweight or do not exercise are at higher risk for breast cancer after menopause. This study will test a new electronic device that measures the body's movement and works alongside a website to help women increase their physical activity level. If effective, this system could be tested in larger studies aiming to reduce breast cancer risk by reducing or preventing obesity.

NCT ID: NCT01837095 Completed - Clinical trials for Metastatic Breast Cancer

Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer

Start date: June 2013
Phase: Phase 1
Study type: Interventional

POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin. Different doses and dosing frequencies will be investigated

NCT ID: NCT01835236 Completed - Clinical trials for Metastatic Breast Cancer

Trastuzumab & Pertuzumab Followed by T-DM1 in MBC

Start date: March 3, 2013
Phase: Phase 2
Study type: Interventional

In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician's discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer.

NCT ID: NCT01834950 Completed - Clinical trials for Untreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast Cancer

Identification of Early Markers of Response and Resistance to Trastuzumab

HERBIN
Start date: March 27, 2013
Phase: N/A
Study type: Interventional

The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed by breast conserving surgery. The investigators will study the association between the value of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors response (partial and complete response) using a logistic regression (main analysis).

NCT ID: NCT01834521 Completed - Breast Cancer Clinical Trials

Web-based Screening and Tailored Support

ENCOURAGE
Start date: January 2013
Phase: N/A
Study type: Interventional

The ever expanding breast cancer survivor population urges the health care system to develop (cost-)effective screening and management of convalescent care needs that can be easily implemented in conventional follow-up care. Internet-delivered systems may be well-equipped to meet these demands. The aim of the current study is to assess the effectiveness of a web-based support system. Key features of this system are patient self-screening of physical and psychosocial problems, tailored patient education on reported problems and self-referral to professional care. In this era of high internet usage, we expect that internet is a highly suitable medium to provide tailored support for breast cancer patients and will empower the patient to take control over their convalescence.

NCT ID: NCT01832051 Completed - Clinical trials for Metastatic Breast Cancer

Clinical Value of 89Zr-trastuzumab PET

Start date: March 2013
Phase: Phase 2
Study type: Interventional

Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional information, have so far not been able to replace the biopsy. To solve this problem, non-invasive whole body visualization and quantification of HER2 expression by means of the HER2-PET may be a valuable tool. In this prospective multicenter imaging study, eligible patients will receive one HER2-PET and CTC analysis in addition to standard work up for metastatic disease. Subsequent administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three questionnaires, one before HER2-PET and two after HER2-PET.