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Breast Neoplasms clinical trials

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NCT ID: NCT00050167 Completed - Breast Cancer Clinical Trials

Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer

Start date: November 2002
Phase: Phase 1
Study type: Interventional

Primary Objectives: - Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer. - Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel. - Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).

NCT ID: NCT00050141 Completed - Breast Cancer Clinical Trials

Study of Letrozole Plus Tipifarnib or Placebo in the Treatment of Advanced Breast Cancer

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

The purpose of this study is to determine if the addition of tipifarnib to standard letrozole therapy leads to a better response to treatment for your cancer in comparison to letrozole plus a placebo. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.

NCT ID: NCT00050011 Completed - Osteoporosis Clinical Trials

Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy

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

This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive Letrozole 2.5 mg daily as an adjuvant therapy.

NCT ID: NCT00049660 Terminated - Breast Cancer Clinical Trials

Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer

Start date: September 2002
Phase: Phase 2/Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if capecitabine is more effective than vinorelbine in treating metastatic breast cancer. PURPOSE: Randomized phase II/III trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy.

NCT ID: NCT00049452 Completed - Breast Cancer Clinical Trials

Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer

Start date: December 2001
Phase: Phase 3
Study type: Interventional

RATIONALE: It is not yet known whether zoledronate is effective in preventing bone loss in premenopausal women who are receiving adjuvant chemotherapy after undergoing surgery for early stage breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in preventing bone loss in premenopausal women who are receiving chemotherapy after surgery for early stage breast cancer.

NCT ID: NCT00049244 Active, not recruiting - Breast Cancer Clinical Trials

BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer

Start date: September 2002
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline.

NCT ID: NCT00049114 Completed - Clinical trials for Stage IIIA Breast Cancer

Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced Breast Cancer

Start date: February 2003
Phase: Phase 2
Study type: Interventional

Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining tipifarnib with doxorubicin and cyclophosphamide may kill more tumor cells. Phase II trial to study the effectiveness of combining tipifarnib with doxorubicin and cyclophosphamide in treating women who have locally advanced breast cancer.

NCT ID: NCT00049062 Completed - Breast Cancer Clinical Trials

Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer

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

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in treating postmenopausal women who have metastatic breast cancer that has not responded to hormone therapy.

NCT ID: NCT00048893 Terminated - Breast Neoplasms Clinical Trials

Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer

Start date: November 2002
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the effectiveness of chemotherapy and a combination of vaccines to treat metastatic breast cancer (breast cancer that has spread beyond the breast) in patients whose cancer cells have a protein called carcinoembryonic antigen (CEA) on their surface. Patients who require surgery or radiation therapy, or both, will receive these treatments as well. Patients 18 years of age and older with previously untreated metastatic breast cancer may be eligible for this study. Newly diagnosed patients may not have received prior chemotherapy. Patients previously diagnosed with local disease may have received chemotherapy or radiation therapy at least 18 months before entering the current study. Patients may have received hormonal therapy for stage IV disease. Candidates are screened with a medical history and physical examination, blood and urine tests, x-rays, heart and lung tests, and a test to determine the presence of CEA on their tumor cells. Participants undergo the following procedures: 1. Central venous line: Under local or general anesthesia, an intravenous catheter (plastic tube) is inserted into a major vein in the chest. It is used to give chemotherapy and other medications and to withdraw blood samples. 2. Apheresis: Before beginning treatment and at various times before and after chemotherapy, patients undergo apheresis to collect white blood cells for later re-infusion at the time of immunizations and to evaluate the body's response to the vaccines. For this procedure, blood is collected through the central venous catheter and circulated through a machine that separates the white cells from the rest of the blood. The white cells are removed and frozen for later use. The rest of the blood is returned to the patient through the catheter. 3. First vaccine: Before starting chemotherapy, patients receive one subcutaneous (under the skin) injection of a vaccine called rV-CEA-Tricom, along with subcutaneous injections of granulocyte macrophage colony stimulating factor (GM-CSF) (Sargramostim), a drug that stimulates the bone marrow to release white blood cells and white cell precursors into the bloodstream. 4. Chemotherapy: - Taxol (paclitaxel)/Cytoxan (cyclophosphamide): Patients receive three to five cycles of Taxol and Cytoxan. Taxol is given as a continuous 72-hour intravenous (intravenous (IV), through a vein) infusion and Cytoxan is given daily for 3 days, intravenously, over 1 hour. Cycles are 21 to 42 (usually 28) days. After each cycle, patients also receive growth colony stimulating factor (G-CSF) (a drug that helps boost white cells.

NCT ID: NCT00048633 Completed - Breast Neoplasms Clinical Trials

Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer

Start date: November 2001
Phase: Phase 2
Study type: Interventional

The primary objective of this phase II study is to assess if XR9576, a selective MDR-1 inhibitor, is able to reverse primary doxorubicin or taxane resistance in advanced breast cancer. Clinical activity will be measured by objective tumor response rates observed after treatment with XR9576 in combination with taxane or anthracycline containing chemotherapy in patients previously resistant to the same agent(s). The secondary objectives of the study are to assess the biological activity of XR9576 and evaluate MDR-1 expression in these tumors. The MDR-1 inhibitory activity of XR9576 will be evaluated by serial sestamibi scans of the tumor. MDR-1 expression will be detected by immunohistochemistry.