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Breast Cancer clinical trials

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NCT ID: NCT01375023 Terminated - Breast Cancer Clinical Trials

Allogenic Haematopoietic Cell Transplantation for Patients With Refractory "Triple Negative" Breast Cancer

Start date: June 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the engraftment, toxicity and anti-tumour activity of allogeneic peripheral blood progenitor cell (PBPC) transplantation using TLI/ATG conditioning regimen in patients with refractory "Triple Negative" breast cancer.

NCT ID: NCT01374685 Terminated - Breast Cancer Clinical Trials

Family Communication of Hereditary Breast and Ovarian Cancer Risk Among African Americans

Start date: June 7, 2011
Phase:
Study type: Observational

Background: - Certain genetic mutations are linked to higher rates of cancer. It is important for people with these mutations to tell their families about it. This is because others in the family may also be at greater risk for developing these cancers. They can also pass these genes to their own children. But not much is known about how African Americans tell their family members about the results of their genetic testing. The information from this study can be used to improve genetic counseling services. These services will then be more effective in early cancer detection and prevention in the African American community. Objectives: - To learn more about how African Americans who have tested positive for BRCA1/2 mutations tell their families about their genetic risk. Eligibility: - African American (or of African descent) women who recently received positive test results for BRCA1/2 mutations. Design: - Participants will be screened with a basic medical history. - They will be asked general questions about their personal and family history. These include questions on marital and health insurance status, education, and income. - Those in the study will have a 45- to 60-minute phone interview. They will answer questions about how they told their family members about their genetic test results. They will also be asked what that experience was like.

NCT ID: NCT01370239 Terminated - Breast Cancer Clinical Trials

HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy

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

The humanized monoclonal antibody against Lewis Y antigen (Hu3S193) has been demonstrated to be safe in previous studies and has also been indicated as potential intervention in breast cancer. The study of this new agent in advanced breast cancer may contribute to the development of new strategies for patients that progressed after hormonal treatment.

NCT ID: NCT01363986 Terminated - Breast Cancer Clinical Trials

A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer

Start date: September 2011
Phase: Phase 2
Study type: Interventional

This single-arm, multicenter, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in patients with HER-2 positive breast cancer. The patients will receive Herceptin 4 mg/kg (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. The anticipated time on study treatment is 18 weeks.

NCT ID: NCT01362712 Terminated - Breast Cancer Clinical Trials

Exploratory, Phase I,Open Label,Non-randomized Study of [F18]CP-18 PET in Normal and Breast Cancer Subjects

Start date: May 2011
Phase: Phase 1
Study type: Interventional

This trial will be the first trial for the IP, [F-18]CP-18, and will be conducted as an exploratory Phase I trial designed to collect information as this IP is administered and evaluated for the first time in humans. The trial will evaluate safety, biodistribution and dosimetry data in normal subjects and the trial will evaluate safety, biodistribution and tumor to background imaging data, and correlate image data with caspase 3 activity level on a surgical specimen analyzed by immunohistochemistry in the cancer subjects. All study results will be evaluated and analyzed in order to consider the design for future clinical trials. The information collected under this exploratory, Phase I study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.

NCT ID: NCT01355523 Terminated - Breast Cancer Clinical Trials

The Effect of Melatonin on Depression, Anxiety, Cognitive Function and Sleep Disturbances in Breast Cancer Patients

MELODY
Start date: July 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of 6 mg melatonin daily for 1 week preoperatively to 12 weeks postoperatively on depressive symptoms, anxiety, cognitive function and sleep disturbances in breast cancer patients. Furthermore the investigators will examine whether a specific clock-gene (HPER3) is correlated with an increased risk of depression, sleep disturbances or cognitive dysfunction.

NCT ID: NCT01351844 Terminated - Breast Cancer Clinical Trials

The CEASE Study: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer

CEASE
Start date: May 2011
Phase: N/A
Study type: Interventional

Patients have been asked to participate in the CEASE study because their treating oncologist has recommended that they start an aromatase inhibitor medication. These medications are associated with joint complaints. The purpose of this study is to see whether a computer-based educational module is a feasible intervention to help address these symptoms. If the patients agree to participate, a research coordinator will test their grip strength and give them a computer log-on code. They will be shown how to log-on to complete the educational module and a few simple questionnaires. Patients have the option to do this from home if they wish. In 3 months time, the investigators will ask patients to return to the clinic and have another grip strength evaluation and complete some additional questionnaires. The computer module and the follow up visit will each take about 30 minutes of time.

NCT ID: NCT01346579 Terminated - Breast Cancer Clinical Trials

Biomarkers in Tissue Samples From Older Women With Breast Cancer

Start date: April 2011
Phase: N/A
Study type: Observational

This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast cancer. Studying samples of tissue from patients with stage I breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

NCT ID: NCT01339000 Terminated - Breast Cancer Clinical Trials

Improving the Immune System With Human IL-7 Vaccine in Older Subjects Who Have Had Chemotherapy

Start date: April 2011
Phase: Phase 2
Study type: Interventional

Background: Drugs given to treat cancer (chemotherapy) can weaken the human immune system. But it can also become weaker because of aging. Interleukin (IL)-7, a molecule produced naturally in the body, can help improve the function of the immune system. Researchers want to study the effects of IL-7 on immune system function in two different groups of older people. One group will be people who have received vaccines before IL-7. The other group will be people who have received Vaccines after IL-7. Objectives: To evaluate the effect of IL-7 on the immune system responses to vaccines in older people following chemotherapy. Eligibility: People at least 60 years of age who have recently finished chemotherapy for breast, colon, or bladder cancer. Design: - People in the study will be screened with a physical examination, medical history, and blood tests. Other screening tests, such as tumor imaging, may also need to be performed. - Everyone will receive a series of five different vaccines commonly used to prevent diseases. We will compare the responses of people in Sequence 1 who will receive vaccines before IL-7 with the responses of people in Sequence 2 who received the same vaccines after IL-7. - The vaccines will be given randomly in two Arms at different times. - Arm 1: diphtheria and tetanus, polio, pneumonia (with two booster shots), hepatitis B (with two booster shots), and hepatitis A (with one booster shot), - Arm 2: hepatitis A (with one booster shot), hepatitis B (with two booster shots), pneumococcal (with two booster shots), diphtheria and tetanus, polio, pneumonia (with two booster shots) - There are 5 vaccines to be given to each subject, following one of two randomly assigned sequences of vaccine administration ( Sequence 1 or Sequence 2 ). - The first vaccine arm contains the two diphtheria protein containing vaccines (Td and PCV13) and polio. The second vaccine arm contains the Hepatitis A and Hepatitis B vaccines. Subjects will either get tetanus, diphtheria, polio, and pneumonia vaccines before IL-7 therapy ( Sequence 1 ) or hepatitis A and hepatitis B vaccines before IL-7 therapy ( Sequence 2 ). The response to vaccines will be evaluated 4 weeks after vaccination. This will be followed by IL-7 therapy, then administration of the other group of vaccines. Therefore, subjects on both arms will receive the same set of vaccines, just at different times with respect to IL-7 therapy.

NCT ID: NCT01333137 Terminated - Breast Cancer Clinical Trials

A Clinical Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin

Start date: August 2011
Phase: Phase 1
Study type: Interventional

P276-00 is a novel, potent, small-molecule, flavone-derived Cdk 4 D1, Cdk1 B, and Cdk9 T inhibitor, with potent cytotoxic effects against chemosensitive and chemoresistant cancer cell lines.This study is planned to compare efficacy of the standard chemotherapy regimen of gemcitabine and carboplatin when administered with or without P276-00 in subjects with advanced triple negative breast cancer.