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Breast Neoplasms clinical trials

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NCT ID: NCT02400476 Completed - Clinical trials for Early Stage HER2+ Breast Cancer

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

Start date: February 2015
Phase: Phase 2
Study type: Interventional

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.

NCT ID: NCT02395575 Completed - Breast Cancer Clinical Trials

A Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay

Start date: March 2015
Phase: N/A
Study type: Observational

The primary objective of this study is to evaluate the impact of the result of the Prosigna Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone therapy) in patients suffering from early-stage breast cancer.

NCT ID: NCT02393924 Completed - Breast Cancer Clinical Trials

Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study

ESTHER
Start date: February 23, 2015
Phase:
Study type: Observational [Patient Registry]

This disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment regimen measured as progression-free survival.

NCT ID: NCT02393287 Completed - Clinical trials for Metastatic Breast Cancer

Retroprospective Real Life Observatory of Eribulin

ReProLine
Start date: November 2014
Phase:
Study type: Observational

The objective of this observatory is to evaluate the effecacy of Eribulin in patients with metastatic breast cancer on a recent prescription period. Part of the data collection will be retrospective and the other part will be prospective for patients started treatment by Eribulin between November 2014 and September 2015. It will allow a better assessment on the safety profile of this drug.

NCT ID: NCT02392845 Completed - Clinical trials for Metastatic Breast Cancer

A Pilot Dose Escalation Trial of a Densified Chemotherapy Association of Docetaxel and Epirubicin Driven by Mathematical Modeling in Metastatic Breast Cancer Patients: The MODEL1 Study

MODEL1
Start date: June 2005
Phase: Phase 1
Study type: Interventional

To determine the maximum tolerated dose of a densified regimen of the association of docetaxel (DTX) and epirubicin (EPI), supported by the concomitant administration of hematopoietic growth factors in patients with metastatic breast cancer in first-line, optimizing in each patient the administration schedule using a formal procedure based on mathematical models in order to manage the severity of induced neutropenia. The models used in this project allow: - an optimal administration schedule of the planned total dose per cycle (number of infusions and calculating their rates and durations) - an individualization of the administration schedule from the second cycle (based on observations from the first cycle), and - an assessment of the risk of a dose-limiting toxicity event combining several severe non-hematological toxicities (conditioning the decision for dose escalation). Using formal mathematical models the investigators expect controlling the hematological and non-hematological toxicities in order to realize the full series of six cycles of densified DTX+EPI chemotherapy (2 weeks per cycle) for each patient. For each patient, chemotherapy is considered feasible if it is possible, in the absence of tumor progression, to consider 6 cycles of treatment without observing any serious adverse events and without: - patient death that may be related to the treatments; - decision of the patient to interrupt treatment for physical or psychological tolerance reasons; - decision of the investigator to discontinue treatment, in the absence of disease progression.

NCT ID: NCT02391727 Completed - Clinical trials for Colon Cancer, Breast Cancer, Cancer of the Head and Neck

Safety, Immunogenicity and Pharmacokinetics of SYN004 in Patients With Solid Tumors

SYN004_Ph_1
Start date: May 2015
Phase: Phase 1
Study type: Interventional

A first-in-human evaluation of SYN004, a monoclonal antibody that binds to the EGF receptor on cancer cells. Cetuximab, a marketed antibody, has been shown to be effective by inhibiting the growth of cancer cells thereby prolonging the life of patients who have received it. SYN004 is a closely related monoclonal antibody also binds to the EGF receptor in the same way. SYN004 might also inhibit cancer cells and prolong life but has been engineered to avoid some of the hypersensitivity reactions known to provoked by cetuximab.

NCT ID: NCT02391194 Completed - Breast Cancer Clinical Trials

Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery

Start date: April 2015
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.

NCT ID: NCT02387099 Completed - Breast Cancer Clinical Trials

Dose EScalation Induction of EvERolimus

Desiree
Start date: May 2015
Phase: Phase 2
Study type: Interventional

The BOLERO-2 study demonstrated a benefit for patients who received everolimus in addition to exemestane in patients who progressed during/after a non-steroidal aromatase inhibitor; Routine use of everolimus shows an high rate of intolerability due to mucositis/stomatitis especially during the first 12 weeks of treatment leading cause for treatment discontinuation not related to tumor progression; GeparQuinto study (setting III: non-responders): everolimus was given as salvage treatment in combination with paclitaxel for patients without response to 4 cycles epirubicin/cyclophosphamide with/without bevacizumab. A dose-escalation schema was successfully used to improve tolerability of everolimus together with the cytotoxic Agent. Everolimus plus exemestane has improved the prognosis of metastatic breast cancer significantly. Desiree-study aims to improve the tolerability, which is necessary in order to achieve an adequate dose intensity for the patients in Routine care.

NCT ID: NCT02386371 Completed - Breast Carcinoma Clinical Trials

Intraoperative Radiotherapy After Local Recurrence in Breast Cancer

RE-IORT01
Start date: March 2014
Phase: N/A
Study type: Interventional

The investigators propose a prospective, multicenter, single arm Phase II design to evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.

NCT ID: NCT02386176 Completed - Breast Cancer Clinical Trials

Assessment of Automated Breast Ultrasound

Start date: August 2015
Phase:
Study type: Observational

The investigators are interested in assessing the value of and comparing the use of automated breast ultrasound (ABUS) (either as a primary screening approach or as a supplementary procedure) with digital breast tomosynthesis (DBT). The purpose of this project is to perform a preliminary prospective study on women who are most likely to benefit from the use of ABUS and/or DBT (or a combination of both) in the screening environment.