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Breast Neoplasms clinical trials

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NCT ID: NCT01506609 Completed - Clinical trials for Metastatic Breast Cancer

Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

Start date: January 23, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.

NCT ID: NCT01506466 Completed - Breast Cancer Clinical Trials

Weight Variation During Chemotherapy in Breast Cancer Patients

Start date: September 2011
Phase: N/A
Study type: Interventional

Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied. Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.

NCT ID: NCT01504789 Active, not recruiting - Breast Cancer Clinical Trials

Part II: Exercise in Hispanic Breast Cancer Survivors

Start date: February 7, 2012
Phase: N/A
Study type: Interventional

The goal of this research study is to test an exercise program that is designed for Hispanic breast cancer survivors. Researchers want to learn the most effective strategies for promoting exercise.

NCT ID: NCT01503905 Recruiting - Clinical trials for Breast Cancer Nos Premenopausal

Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients

Start date: December 2011
Phase: N/A
Study type: Interventional

The current study is a multicentre, randomized, open (unblended), prospective clinical trial which is sponsored by the researchers. The trial is designed to compare the effectiveness between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant chemotherapies. The investigators will randomly assign 600 premenopausal female patients with operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy. Patients will undergo modified radical mastectomy or breast-conserving surgery after four cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles), radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011) guideline. The follow-up will be ten years after surgeries. The primary aim is to examine whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin, and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival (PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced amenorrhea with outcomes in premenopausal women.

NCT ID: NCT01503697 Not yet recruiting - Breast Cancer Clinical Trials

The Role of the Novel 99mTc-NC100692 Tracer in Patients at High Risk or Known Breast Cancer

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

Technetium-99m NC100692 Injection is under development as a diagnostic radiopharmaceutical for targeting angiogenesis associated with diseases such as primary and metastatic cancer, and for targeting active fibrosis in cardiac diseases such as developing heart failure and developing hypertrophic cardiomyopathy. A principle goal of imaging is identification of disease processes early in their development, at times prior to symptoms. In cancer, angiogenesis is essential for a tumour to exceed approximately 1-2 mm3 in size.As markers of angiogenesis are often expressed early in the growth of a tumour it is postulated that imaging of angiogenesis can assist in early diagnosis of cancer, relapse or spread, and monitoring response to therapy. Technetium-99m NC100692 Injection will be tested on 3 populations of pts: 1.30 patients at high risk For breast cancer 2.30 patients with breast cancer 3.15 patients with locally advanced breast cancer undergoing treatment.

NCT ID: NCT01503190 Recruiting - Breast Cancer Clinical Trials

The Immune System's Response to Young Women's Breast Cancer

Start date: July 21, 2009
Phase:
Study type: Observational

This study plans to learn more about the immune system's response to breast cancer in young women.

NCT ID: NCT01503034 Completed - Breast Cancer Clinical Trials

Pregnant Women With a Breast Cancer Diagnosed Between 2000 and 2014

Start date: December 14, 2010
Phase:
Study type: Observational

This is a non-interventional, retrospective, multicentre study involving women having had a breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and non-pregnant women having had a breast cancer between 2000 and 2009 (controls).

NCT ID: NCT01502592 Completed - Breast Cancer Clinical Trials

Pre-Operative, Single-Dose Ipilimumab and/or Cryoablation in Early Stage/Resectable Breast Cancer

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

This study is being done to evaluate the safety of two strategies called "cryoablation" and "immune therapy" in women with curable early stage breast cancer. "Cryoablation" is a procedure performed by an expert doctor called a radiologist. The radiologist uses (magnetic resonance imaging (MRI) to insert a needle directly into a cancer. Very cold temperatures are then applied through the needle to kill the cancer cells. Some of the killed cancer cells will be broken into pieces that can be recognized by a person's immune system. The "immune therapy" in this study is a drug called ipilimumab. Normally the immune system makes "T cells" that can kill cancer cells when turned on. The cancer-killing T cell activity is controlled by a molecule called CTLA4. Ipilimumab works by turning off CTLA4. Turning off CTLA4 allows the cancer-fighting T cells to remain active Ipilimumab is an antibody drug has been made in a laboratory for patient use and was recently approved by the United States Food and Drug Administration (FDA) for the treatment of patients with a type of skin cancer called melanoma. An antibody is a normal protein that the immune system uses to find and kill germs like bacteria and viruses. This study is being done because the researchers believe that when cryoablation is combined with immune therapy, a person's immune system can be trained to recognize that person's cancer. This may prevent that cancer from coming back in the future. In other words, it is hoped that by adding cryoablation with ipilimumab before the mastectomy, the body will remain cancer free long after the mastectomy is performed. The first step in determining whether cryoablation and immune therapy can be used to cure breast cancer is to evaluate the safety of each strategy alone and then in combination in a small group of patients.

NCT ID: NCT01501669 Recruiting - Clinical trials for Metastatic Breast Cancer

Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer

PROCEED
Start date: June 2011
Phase: Phase 3
Study type: Interventional

This study is a multicenter, randomized study, open-label, phase III study.The efficacy of irinotecan and capecitabine combination will be superior to capecitabine alone in term of progression free survival in metastatic breast cancer patients previously treated with anthracycline and taxane.

NCT ID: NCT01501656 Completed - Breast Cancer Clinical Trials

Epigenetic Testing for Breast Cancer Risk Stratification

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

Promoter region hypermethylation of tumor suppressor genes is one the earliest molecular events in malignant transformation and is readily detectable in apparently normal benign breast epithelium adjacent to breast cancers. The investigators hypothesize that DNA methylation of certain genes occurs as a field change in benign breast tissue that is at high risk for malignant transformation, and as such, can be exploited for tissue-based breast cancer risk stratification. Additional work is required to identify new DNA methylation markers potentially useful for periareolar fine needle aspiration (RP-FNA)-based breast cancer risk stratification, to determine whether these markers are methylated more frequently in benign samples from women who develop breast cancer, to determine whether assessment of these markers is reproducible, to determine whether tamoxifen reduces DNA methylation, and to better understand the pattern of DNA methylation in benign samples from unselected healthy control populations. Each of these objectives contributes to advancement of a clinically useful RP-FNA-based breast cancer risk stratification test. In addition, identification of genes that are preferentially methylated in estrogen receptor (ER) negative breast cancer will provide clues to the underlying biology responsible for this aggressive form of breast cancer. This knowledge may lead to the discovery of the causes of ER negative breast cancer, approaches for recognizing women at increased risk for this type of breast cancer, and approaches for reducing this risk. This study seeks to identify patterns of DNA methylation in benign breast epithelial cells associated with an increased risk for breast cancer with a focus on ER negative breast cancer.