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Neoplasms, Breast clinical trials

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NCT ID: NCT00148902 Completed - Neoplasms, Breast Clinical Trials

Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

Start date: April 28, 2003
Phase: Phase 1
Study type: Interventional

This is a safety and tolerability study of GW572016 given with docetaxel (TAXOTERE).

NCT ID: NCT00140738 Completed - Neoplasms, Breast Clinical Trials

Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer

Start date: March 10, 2005
Phase: Phase 1
Study type: Interventional

Patients will receive a maximum of 18 injections of dHER2 vaccine in a treatment schedule that will last for up to about a year, and thereafter there will be a follow-up period of about one more year.

NCT ID: NCT00111787 Completed - Neoplasms, Breast Clinical Trials

Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer

Start date: April 11, 2005
Phase: Phase 2
Study type: Interventional

This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.

NCT ID: NCT00105950 Completed - Neoplasms, Breast Clinical Trials

Study Of Lapatinib In Patients With Relapsed Or Refractory Inflammatory Breast Cancer

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

This study was designed to determine how effective and safe a new investigational drug, lapatinib, is in treating patients with treatment refractory or relapsed inflammatory breast cancer. Tumor tissue collected pre-treatment and at Day 28 will be examined for biologic activity by IHC (immunohistochemistry). Treatment will consist of daily oral therapy with lapatinib. A patient may continue treatment as long as they are receiving benefit. Blood samples for hematology and chemistry panels, MUGA/ECHO (multigated acquisition/echocardiogram) exams and physical exams will be performed throughout the study to monitor safety.

NCT ID: NCT00089999 Completed - Neoplasms, Breast Clinical Trials

Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

Start date: June 2004
Phase: Phase 2
Study type: Interventional

This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.

NCT ID: NCT00089973 Completed - Neoplasms, Breast Clinical Trials

Study Of Ispinesib In Subjects With Breast Cancer

Start date: June 30, 2004
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to find how breast cancer responds to the investigational drug, Ispinesib. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. In particular, this study will try is to find the answers to the following research questions: 1. Does breast cancer respond to Ispinesib? 2. What are the side effects of Ispinesib? 3. How much Ispinesib is in the blood at specific times after it is taken?

NCT ID: NCT00075270 Completed - Neoplasms, Breast Clinical Trials

Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Start date: January 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.

NCT ID: NCT00062686 Completed - Neoplasms, Breast Clinical Trials

GW572016 For Treatment Of Refractory Metastatic Breast Cancer

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

This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.

NCT ID: NCT00058526 Completed - Neoplasms, Breast Clinical Trials

A Dose-escalation Vaccine Trial in HER2-overexpressing Patients With High-risk Breast Cancer

Start date: March 20, 2003
Phase: Phase 1
Study type: Interventional

Treatment phase: The purpose of this study is to evaluate the safety and the immune response elicited by a new anti-cancer therapy in patients with breast cancer in remission but who are at high risk of relapse. The study product is an immunotherapeutic consisting of the recombinant dHER2 protein combined with an immunostimulant called AS15. The study aims to determine the optimal of three different dose levels of dHER2 combined with the same fixed dose of AS15 by assessing the safety and the immune response elicited after a series of injections of the study product. Five-year follow-up phase: This part of the study aims to assess any late onset toxicity of the study treatment through yearly follow-up visits and to monitor the patients' survival and disease status up to five years after the last administration of the study treatment. The patients' immune response is also measured to assess the robustness of the immune response elicited by the study treatment.

NCT ID: NCT00051103 Completed - Clinical trials for Metastatic Breast Cancer

Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.

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

The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.