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Neoplasms, Breast clinical trials

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NCT ID: NCT00347919 Completed - Neoplasms, Breast Clinical Trials

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer

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

This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein.

NCT ID: NCT00338247 Approved for marketing - Neoplasms, Breast Clinical Trials

EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

Start date: July 2006
Phase: Phase 4
Study type: Expanded Access

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

NCT ID: NCT00320411 Completed - Neoplasms, Breast Clinical Trials

GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer

Start date: November 28, 2005
Phase: Phase 2
Study type: Interventional

This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with the data from EGF100642 and integrated analysis will be carried out in order to enhance the credibility of the study results.

NCT ID: NCT00320385 Completed - Neoplasms, Breast Clinical Trials

Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

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

This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.

NCT ID: NCT00281658 Completed - Neoplasms, Breast Clinical Trials

Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2

Start date: January 2, 2006
Phase: Phase 3
Study type: Interventional

This was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified metastatic (Stage IV) breast cancer who had not received prior therapy for metastatic disease.

NCT ID: NCT00272987 Terminated - Neoplasms, Breast Clinical Trials

ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

Start date: December 13, 2005
Phase: Phase 3
Study type: Interventional

This study was originally designed as a Phase III randomized, double blind, placebo controlled study to assess the safety and tolerability, and efficacy of paclitaxel plus trastuzumab plus lapatinib compared with paclitaxel plus trastuzumab plus placebo in women with ErbB2 overexpressing metastatic breast cancer. The planned study was a two stage design with an initial open-label safety stage to be conducted in approximately 65 subjects followed by a randomized phase conducted in a further 700 subjects. The open-label part of the study sequentially enrolled three cohorts with patients receiving a different dose combination of paclitaxel, trastuzumab and lapatinib. Following poor recruitment rate in the open label stage, the randomized stage of the study was terminated, thus no subjects were enrolled into the randomization stage.

NCT ID: NCT00263588 Completed - Neoplasms, Breast Clinical Trials

Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Start date: December 2, 2005
Phase: Phase 2
Study type: Interventional

Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.

NCT ID: NCT00258050 Completed - Neoplasms, Breast Clinical Trials

To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients

Start date: November 21, 2005
Phase: Phase 1
Study type: Interventional

To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics of a single oral and single intravenous dose of midazolam in adult cancer patients. Also to assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.

NCT ID: NCT00251433 Terminated - Neoplasms, Breast Clinical Trials

GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

Start date: September 26, 2005
Phase: Phase 1
Study type: Interventional

This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together. Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three drugs compared to patients receiving only docetaxel and trastuzumab.

NCT ID: NCT00169533 Completed - Neoplasms, Breast Clinical Trials

Rollover Study Of Lapatinib In Cancer Patients

Start date: August 19, 2004
Phase: Phase 1
Study type: Interventional

The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending FDA approval.