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Breast Cancer clinical trials

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NCT ID: NCT00127205 Completed - Breast Cancer Clinical Trials

S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.

Start date: July 2005
Phase: Phase 3
Study type: Interventional

RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.

NCT ID: NCT00124111 Completed - Breast Cancer Clinical Trials

A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast Cancer

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the relative dose intensity (RDI) of intravenous (IV) CMF on a Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with stage I-III breast cancer.

NCT ID: NCT00123929 Completed - Breast Cancer Clinical Trials

Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer

Start date: January 2005
Phase: Phase 2
Study type: Interventional

After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100 mg/m2 e3w). After the fourth cycle, patients are submitted to surgery to ascertain pathological response. They then receive the opposite drug, hormones, Herceptin, and radiation as indicated.

NCT ID: NCT00122369 Completed - Breast Cancer Clinical Trials

Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy

Start date: March 2002
Phase: Phase 2
Study type: Interventional

Percutaneous large core image-guided breast biopsy is a well established tool in diagnosing breast cancer, but the associated anxiety and pain can tax the coping mechanism of even well functioning individuals. Unabated stress during an invasive procedure not only interferes with smooth progression of the ongoing procedure, but can also have deleterious effects when patients need additional procedures and dread recurrent medical traumatization. The long-term objective of this research is to provide patients with a simple coping strategy at the vulnerable time of large core biopsy in the hope that this behavioral intervention will carry over to recovery and future medical procedures. In the largest prospective randomized study of its kind, the researchers showed that a self-hypnotic intervention during percutaneous, image-guided vascular and renal interventions resulted in less pain and anxiety, greater hemodynamic stability, and fewer procedure interruptions. The positive effects of the short initial hypnotic intervention, which was structured in the procedure room, became more pronounced the longer the procedure lasted and carried over into the immediate post-procedure recovery. The investigators therefore challenge the current paradigms that long-lasting effects require intensive presurgical preparation.

NCT ID: NCT00122356 Completed - Breast Cancer Clinical Trials

Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment

BATMAN
Start date: September 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.

NCT ID: NCT00121836 Completed - Breast Cancer Clinical Trials

A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer

Start date: June 2005
Phase: Phase 4
Study type: Interventional

This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was <100 individuals.

NCT ID: NCT00121134 Completed - Breast Cancer Clinical Trials

Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer

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

The purpose of this research study is to study the effects (good and bad) of bevacizumab alone, bevacizumab with low-dose continuous chemotherapy (called metronomic chemotherapy), or bevacizumab with capecitabine, on you and your cancer. The goals of the study will be to: - Examine the safety of these drugs - See how easy or difficult it is to be treated with them - Monitor for any signs of recurrent cancer - Look at blood markers that might indicate how the treatment is working

NCT ID: NCT00120692 Completed - Breast Cancer Clinical Trials

Treatment for Patients Suffering From Anemia Due to Chemotherapy

Start date: October 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in female breast cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.

NCT ID: NCT00120016 Completed - Breast Cancer Clinical Trials

Design and Feasibility of a Mediterranean Diet

Start date: January 2004
Phase: N/A
Study type: Interventional

Epidemiological observations indicate that a Greek-Mediterranean dietary pattern has great potential for cancer prevention, but more definitive data on the preventive effects of this diet are needed. Two distinct aspects of this eating pattern are the type of fat consumed and a high fruit/vegetable intake. If the diet is feasible, it could be used in future clinical trials of breast cancer prevention. In this study, women randomly receive either a control diet or an intervention diet for 6 months. The intervention diet replaces half of the typical American fat intake with foods such as olive oil and nuts. The fruit and vegetable goal is 7-9 servings/day and includes several categories of fruits, vegetables, and herbs. Blood samples are drawn and analyzed for fatty acids derived from fats, micronutrients from fruits and vegetables, and markers of oxidative stress. This dietary trial will provide important data on the ability of women following typical American eating patterns to change their dietary intakes to reflect a Greek-Mediterranean pattern.

NCT ID: NCT00117910 Completed - Breast Cancer Clinical Trials

Treatment for Elderly Patients With High Risk Breast Cancer

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

This open-label, multicenter study explored primary and secondary prophylaxis treatment with a single, fixed-dose, subcutaneous (SC) injection of pegfilgrastim in elderly subjects with high-risk breast cancer receiving myelosuppressive chemotherapy. The primary objective was to provide preliminary information on the incidence of protocol defined neutropenic events in chemotherapy cycle 1.