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Breast Neoplasms clinical trials

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NCT ID: NCT00355316 Completed - Breast Neoplasms Clinical Trials

A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients

Start date: November 2005
Phase: N/A
Study type: Interventional

This study is designed to determine whether molecular detection of breast cancer cells in the peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of progression-free and overall survival. Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment. Multi-marker real-time RT-PCR analysis will be performed on peripheral blood specimens from 92 breast cancer patients and 120 healthy volunteers. Peripheral blood specimens from breast cancer patients will be obtained at the time of study entry (prior to initiation of systemic therapy) and at serial time points during follow-up. Subjects will be followed longitudinally until death, although the study has been powered so that the primary objective can be addressed after 12 months of follow-up. Healthy volunteers will be asked to provide a blood sample at time of enrollment but will not be followed.

NCT ID: NCT00354900 Terminated - Clinical trials for Metastatic Breast Cancer

Phase I Study of Aprotinin in Advanced Breast Cancer

Start date: July 2006
Phase: Phase 1
Study type: Interventional

There is an intimate relationship between processes which promote growth, invasion, and metastasis of cancers, and processes which regulate blood clotting. The enzymes uPA and PAI-1 are key regulators of the remodeling of recently formed blood clots, and there is substantial information linking greater levels of uPA and PAI-1 in breast cancers with a greater likelihood of breast cancer recurrence and death. As uPA and PAI-1 are excellent markers for a cancer's aggressive clinical behavior, uPA and PAI-1 may be potential targets for anticancer therapy. Aprotinin is an inhibitor of uPA activation, and has been approved by the FDA to reduce blood loss in patients undergoing cardiopulmonary bypass surgery. Studies in animals and limited studies in patients have shown that Aprotinin slows the growth of tumors. Our hypothesis is that uPA is chronically activated in malignancies, and that inhibition of uPA by Aprotinin would slow the rate of progression of breast cancer.

NCT ID: NCT00354640 Completed - Breast Cancer Clinical Trials

Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer

Start date: June 2006
Phase: Phase 2
Study type: Interventional

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin and anastrozole may stop cancer from forming, growing, or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer. PURPOSE: This phase II trial is studying how well giving simvastatin together with anastrozole works in treating postmenopausal women with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.

NCT ID: NCT00354302 Completed - Breast Cancer Clinical Trials

Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial

Start date: April 24, 2006
Phase: Phase 3
Study type: Interventional

RATIONALE: Learning about the effect of exemestane and anastrozole on bone mineral density in postmenopausal women with primary breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably. PURPOSE: This phase III trial is studying bone mineral density in postmenopausal women with primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27.

NCT ID: NCT00353717 Recruiting - Breast Neoplasms Clinical Trials

Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

Start date: November 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Basal like breast carcinoma is a Her2, estrogen receptor (ER) progesterone receptor (PR) negative breast cancer. It is notable for the high level of epidermal growth factor receptor (EGFR) expression in this tumor subtype . Thus the investigators wanted to combine the use of anti EGFR therapy in the form of Erbitux (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of these women. This is a small phase I/II study.

NCT ID: NCT00353483 Recruiting - Breast Neoplasms Clinical Trials

Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

Start date: September 14, 2005
Phase:
Study type: Observational

The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.

NCT ID: NCT00352872 Terminated - Breast Cancer Clinical Trials

Pharmacogenetics as a Predictor of Toxicity in Pre-Menopausal Women Receiving Doxorubicin and Cyclophosphamide in Early Breast Cancer

Start date: February 2005
Phase: N/A
Study type: Observational

The goal of this pilot study is to delineate the role of genetic variations in premature menopause, hot flashes, and other toxicities in a cohort of premenopausal women with early breast cancer. Primary Objective- To ascertain the effect of common variant alleles of CYP450 2B6, 2C19, 2C9, and 3A5 in pre-menopausal women with breast cancer receiving anthracycline and cyclophosphamide based chemotherapy as it relates to occurrence of premature menopause (defined as more than 12 months of amenorrhea and serum estradiol and FSH levels consistent with post-menopausal status) Secondary Objective #1- To obtain pilot data on the effect of common variant alleles of CYP450 2B6, 2C19, 2C9, and 3A5 in pre-menopausal women with breast cancer receiving anthracycline and cyclophosphamide based chemotherapy as it relates to occurrence of hot flash frequency, and other common toxicities of therapy requiring dose delay or reduction. Secondary Objective #2- To obtain pilot data on the correlation of hot flashes with serum levels of serotonin, tryptophan, and their metabolites and with polymorphisms of the serotonin transporter and receptor genes.

NCT ID: NCT00352378 Completed - Breast Cancer Clinical Trials

Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer

Start date: June 2002
Phase: Phase 3
Study type: Interventional

This is an open labeled phase III randomized trial. The patients with clinical stage II and III will undergo mammotome biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor(ER), progesterone receptor(PR), HER-2/neu and others. PET results will determine the positivity of lymph node metastasis.

NCT ID: NCT00351858 Terminated - Breast Cancer Clinical Trials

Safety and Efficacy Study of the Trifunctional Antibody Ertumaxomab to Treat Patients With Advanced or Metastatic Breast Cancer

IV REXBC 02
Start date: July 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of the investigational trifunctional anti-Her-2/neu x anti-CD3 antibody ertumaxomab as treatment for hormone therapy refractory Her-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer

NCT ID: NCT00349934 Completed - Clinical trials for Metastatic Breast Cancer

IMP321 Plus First-line Paclitaxel in Metastatic Breast Carcinoma

Start date: July 2006
Phase: Phase 1
Study type: Interventional

Open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting in patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of weekly paclitaxel (80 mg/m² at D1, D8 and D15 of a 4-week cycle). Three IMP321 doses (0.25, 1.25 and 6.25 mg) will be tested and given at D2 and D16 of this 4-week cycle, for 6 courses.