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Breast Neoplasms clinical trials

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NCT ID: NCT01612910 Withdrawn - Clinical trials for Breast Cancer Female

Oral Microencapsulated Diindolylmethane in Treating Patients With Stage II-III Triple Negative, Androgen Receptor Positive Breast Cancer Who Have Undergone Chemotherapy and Surgery

Start date: June 2012
Phase: Phase 2
Study type: Interventional

This study is being done to find out whether a nutritional supplement, called BioResponse-DIM (BR-DIM [oral microencapsulated diindolylmethane]), improves the survival for women who have residual cancer cells following surgery after chemotherapy for breast cancer. BR-DIM is an active ingredient in cruciferous vegetables (broccoli, brussels sprouts and cauliflower). Consumption of these vegetables has been associated with a decreased risk in several cancers. Researchers also hope to find out whether different biomarkers (also called "markers") in the blood predict the chance of breast cancer returning. BR-DIM is thought to be effective in treating stage II-III breast cancer that is triple negative, AR positive (+), and where there is residual cancer cells in the breast after chemotherapy.

NCT ID: NCT01612871 Completed - Breast Cancer Clinical Trials

Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer

MIRHO
Start date: June 27, 2012
Phase: Phase 4
Study type: Interventional

This is a biomedical and prospective study of interventional type. The trial will include 29 patients over a period of 15 months + 24 months of follow up maximum. The study will be conduct in womens with metastatic invasive breast cancer or locally advanced breast cancer and for which treatment with tamoxifen or anti aromatase (first line hormone therapy for metastatic breast cancer) is indicated. The main objective of this pilot study is to evaluate the feasibility to detect in the circulating blood of patients, before treatment (T0), the presence of the fifteen tissular microRNAs described in preclinical studies as possibly involved in hormone resistance/sensitivity. In parallel of the detection of these specific miRNAs, we will conduct a larger scale analysis of circulating miRNAs in these patients before (T = 0) and after one month of treatment (T28).

NCT ID: NCT01612338 Completed - Breast Cancer Clinical Trials

Interventions to Increase Screening by Breast Cancer Survivors and Their High Risk Female Relatives

Start date: July 2012
Phase: N/A
Study type: Interventional

The University of Michigan (UM) Schools of Nursing, Public Health, and Medicine, the Michigan Department of Community Health (MDCH) and the Michigan Cancer Consortium (MCC) are conducting a multidisciplinary academic/practice three-year project to increase appropriate breast cancer screening for young breast cancer survivors and their cancer-free, female relatives at greatest risk for breast cancer. The aims of this project are to: 1) identify and survey 3000 breast cancer survivors reported to the Michigan Cancer Surveillance Program who were diagnosed between the ages of 20-45 years regarding their breast cancer screening utilization; 2) identify and survey the survivors' female relatives regarding their breast cancer screening utilization; and 3) implement two versions (targeted vs. enhanced tailored) of an evidence-based intervention recommended by the Guide to Community Preventive Services to increase breast cancer screening. A follow-up survey will assess the effectiveness of each intervention on a) breast cancer screening utilization; b) perceived barriers and facilitators to screening; c) self-efficacy in utilizing screening services; d) family support related to screening; e) knowledge of the genetics of breast cancer and personal risk factors; and f) satisfaction with the intervention.

NCT ID: NCT01612247 Recruiting - Breast Cancer Clinical Trials

Low Dose Chemotherapy With Aspirin in Patients With Breast Cancer After Neoadjuvant Chemotherapy

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

Patients with stage II-III breast cancer who do not achieve a pathologic complete response to neoadjuvant chemotherapy at the time of surgery will be treated with oral low dose continuous cyclophosphamide and methotrexate (CM) in combination with aspirin following surgery and radiotherapy. The primary endpoint is to assess toxicity and safety with secondary endpoints of cytokine correlates and relapse free survival (RFS) at 2 years. The investigators design tests the null hypothesis (H0) that the true primary toxicity event rate will be 5% or less, against an alternative hypothesis (HA) event rate of 25% or more.

NCT ID: NCT01611727 Completed - Clinical trials for Metastatic Breast Cancer

Open-Label,Non-Randomized Trial of Cisplatin Chemotherapy in BRCA1-Positive Metastatic Breast Cancer Patients

Cisplatin
Start date: July 2007
Phase: Phase 2
Study type: Interventional

Among women with a BRCA1 mutation and breast cancer, choice of chemotherapy is a critical issue. There are emerging data which suggest that mutation carriers may respond differently than non-carriers to particular agents. BRCA1-associated cancers differ from non-hereditary cancers for a range of pathologic and molecular factors, including tumor grade and histologic appearance. Several studies have shown that the response to treatment for women with a BRCA1-associated breast cancer reflects the underlying tumor biology, in particular, the impairment of the DNA damage response and repair pathways, and that it is possible to exploit the sensitivity of BRCA1-associated cancers to DNA damage. It is equally important that the investigators evaluate the benefit of cisplatin in women with disseminated breast cancer, including those who have previously been treated with one or more chemotherapy regimens. This study is undertaken to evaluate the efficacy of cisplatin chemotherapy in BRCA1 carriers with metastatic breast cancer. The primary objective is to determine the objective response rate of cisplatin in BRCA1 carriers with metastatic breast cancer. The secondary objectives are to determine 3-year survival and to evaluate the toxicities of cisplatin in BRCA1 carriers with metastatic breast cancer.

NCT ID: NCT01611051 Completed - Breast Cancer Clinical Trials

A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy

Start date: March 2012
Phase: Phase 3
Study type: Interventional

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.

NCT ID: NCT01610284 Completed - Breast Cancer Clinical Trials

Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

BELLE-2
Start date: August 7, 2012
Phase: Phase 3
Study type: Interventional

This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

NCT ID: NCT01610050 Completed - Clinical trials for Castration-resistant Prostate Cancer, Advanced Breast Cancer

A Phase I Study of LFA102 in Japanese Patients

Start date: June 2012
Phase: Phase 1
Study type: Interventional

This study will evaluate safety and tolerability to determine the MTD/RD.

NCT ID: NCT01609920 Terminated - Breast Neoplasms Clinical Trials

Nodal Staging in Breast Cancer With MRL

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

The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL). The diagnostic performance of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the golden standard for nodal involvement.

NCT ID: NCT01609127 Recruiting - Clinical trials for Metastatic Breast Cancer

Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer

Start date: May 2012
Phase: Phase 2
Study type: Interventional

This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.