Breast Cancer

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Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant

Trial phase: 
Phase II
Recruitment status: 
Not yet recruiting

RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant. PURPOSE: This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant.

Background information
Trial ID: 
NCT00728585
Other unique IDs: 
CDR0000588622
COG-ACCL0521
Official title: 

A Group-Wide Double-Blind Randomized Placebo-Controlled Trial of Palifermin to Prevent Chemotherapy and/or Radiotherapy Induced Oral Mucositis in Children Undergoing Autologous or Allogeneic Hematopoietic Stem Cell Transplantation

Detailed description: 

OBJECTIVES: Primary

  • To compare whether palifermin versus placebo administered to pediatric patients three days prior to conditioning and three days after autologous or allogeneic hematopoietic stem cell transplantation (HSCT) is associated with a reduction in the incidence of WHO grade 3 or 4 oral mucositis.

Number to be enrolled: 
200 patients

Impact of OncoDoc2 on Guideline Compliance in the Management of Breast Cancer

Recruitment status: 
Recruiting

The objective of the study is to evaluate how the use of OncoDoc2, a computerized guideline-based decision support system, could improve the compliance of multidisciplinary staff meeting decisions with local clinical practice guidelines in the management of non-metastatic breast cancer.

Background information
Trial ID: 
NCT00728442
Other unique IDs: 
K 070603
Official title: 

Impact of the OncoDoc2 Decision Support System on Compliance of Multidisciplinary Staff Meeting Decisions With Clinical Practice Guidelines in the Management of Non-Metastatic Breast Cancer.

Detailed description: 

In France, to promote the quality of cancer care, decisions have currently to be made according to clinical practice guidelines (CPGs) during regularly organized multidisciplinary staff meetings (MSMs). Dissemination of textual CPGs has a poor impact on clinical practice as opposed to the use of clinical decision support systems (CDSSs) known to improve compliance with CPGs.

Number to be enrolled: 
354 patients
Acronym: 
OncoDoc2

The Effect of Aspirin on Angiogenesis Proteins in Women on Tamoxifen Therapy

Trial phase: 
Phase 0
Recruitment status: 
Recruiting

Changes in major angiogenic proteins have been seen following initiation of tamoxifen and aromatase inhibitor therapy in women with breast cancer. One source of these proteins is the circulating platelet pool. The investigators hypothesize that in addition to their anti-platelet properties, agents such as aspirin can be used as targeted anti-angiogenesis therapy. The investigators will determine the influence of aspirin on the release of angiogenic proteins from platelets in 35 patients with breast cancer.

Background information
Trial ID: 
NCT00727948
Other unique IDs: 
V0801
Official title: 

The Impact of the Anti-Platelet Agent Aspirin on Angiogenesis Proteins in Women With Breast Cancer

Detailed description: 

 

Number to be enrolled: 
35 patients

Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients

Recruitment status: 
Completed

Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients

Background information
Trial ID: 
NCT00727883
Other unique IDs: 
NIS-OIT-DUM-2006/1
Official title: 

Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients

Detailed description: 

 

Number to be enrolled: 
190 patients
Acronym: 
SOSTA

A Yoga and Wellness Program for Breast Cancer Survivors With Persistent Fatigue

Recruitment status: 
Recruiting

This randomized controlled trial will compare the effectiveness of an Iyengar Yoga intervention to a Wellness Seminar health education lecture series, for improvements in energy, mood and biological functioning in breast cancer survivors with persistent, post-treatment fatigue. It is anticipated that the Iyengar Yoga intervention will be feasible and acceptable to breast cancer survivors with minimal side effects and that the Yoga intervention will be effective in improving fatigue and physical performance.

Background information
Trial ID: 
NCT00727662
Other unique IDs: 
U01 AT003682
Official title: 

Iyengar Yoga for Breast Cancer Survivors With Persistent Fatigue

Detailed description: 

Fatigue is the most common and distressing side effect of cancer treatment and persists beyond successful treatment completion in approximately 30% of breast cancer survivors, causing serious disruption in quality of life. Behavioral interventions incorporating physical activity or relaxation/stress management have demonstrated beneficial effects on cancer-related fatigue, although research in cancer survivors is limited. Mind-body interventions such as yoga are extremely popular among cancer patients and offer a promising alternative to traditional treatments.

Number to be enrolled: 
72 patients

An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)

This is a multicenter, prospective OCS designed to follow patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts will be included:

  • Patients with HER2-normal disease receiving their first cytotoxic chemotherapy and/or targeted therapy (1500 patients)
  • Patients with HR-positive tumors receiving their first HT for advanced disease (500 patients) Patients who started their first systemic treatment for advanced breast cancer within 1 month prior to enrollment into this OCS will be eligible. A total of approximately 2000 patients will be enrolled. In order to assure that treatment patterns over time are represented in the study, the number of sites activated will be determined by projections to achieve complete enrollment over approximately 18-24 months.

Background information
Other unique IDs: 
AVF4349n

Use of Trastuzumab to Induce Increased ER Expression in ER-Negative/Low, Her-2/Neu Positive Breast Cancer

Trial phase: 
Phase II
Recruitment status: 
Recruiting

The majority pf breast cancers present as ER-positive, many of which are able to be targeted with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has the potential to benefit patients by making hormonal therapies a therapeutic option and possibly improving their overall prognosis.

Background information
Trial ID: 
NCT00726180
Other unique IDs: 
UMCC 2007.130
Official title: 

Evaluation of the Use of Trastuzumab to Induce Increased ER Expression in ER-Negative/Low, Her-2/Neu Positive Breast Cancer

Detailed description: 

 

Number to be enrolled: 
30 patients

Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT

Recruitment status: 
Recruiting

This is a pilot imaging study for women whose tumors express NIS [Na+I- symporter, sodium iodide symporter]. Eligibility is limited to the presence of strong (3+) and/or plasma membrane staining in > 20% of cells as determined by immunohistochemical methods. A total of 10 patients will be imaged with 124I PET/CT (serial scans over 24 hour period) to determine radioiodide uptake and distribution in tumor tissue. Thyroid iodide uptake and retention will be blocked beginning one week prior to 124I PET/CT scan with thyroid hormone (T3) and methimazole (impedes organification). Tumor, organ and whole body dosimetry will be calculated in each patient.

Background information
Trial ID: 
NCT00725946
Other unique IDs: 
SU-03142008-1044
98583
BRS0001
Official title: 

A Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT

Detailed description: 

 

Number to be enrolled: 
10 patients

A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(COMPLETED)

Trial phase: 
Phase III
Recruitment status: 
Completed

The primary purpose of this study is to compare changes in the expression of the proliferation marker Ki-67 in malignant breast tissue after treatment with tibolone or placebo in postmenopausal women who need to undergo surgery for primary breast cancer

Background information
Trial ID: 
NCT00725374
Other unique IDs: 
32971
Official title: 

A Exploratory, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Tissue Specific Effects of 2.5 mg Tibolone on Breast Cancer in Postmenopausal Women, in Particular on Breast Tissue Proliferation.

Detailed description: 

 

Number to be enrolled: 
102 patients
Acronym: 
STEM

Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer

Trial phase: 
Phase I
Recruitment status: 
Completed

The goal of this study is to determine the feasibility based on toxicity and response rate of giving paclitaxel weekly with concomitant every-other week radiotherapy to limit skin toxicity. This study will also seek to determine the maximally tolerated dose of Navelbine added to this combination when followed by Filgrastim and the dose-limiting toxicities of this regimen.

Background information
Trial ID: 
NCT00724386
Other unique IDs: 
UCIRB 9849
Official title: 

A Phase I Study of Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine With Filgrastim Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer

Detailed description: 

 

Number to be enrolled: 
26 patients
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