View clinical trials related to Breast Neoplasms.
Filter by:RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment. PURPOSE: This research study is studying biomarkers in blood samples from older women with stage I, stage II, or stage III breast cancer who have finished primary therapy or breast cancer survivors.
This is an open-label, non-randomized, multi-center study of lapatinib plus paclitaxel to evaluate safety, tolerability and efficacy in Japanese patients with ErbB2 over expressing advanced or metastatic breast cancer. Lapatinib 1500mg/day will be administered in combination with paclitaxel 80mg/m2/week. Lapatinib and paclitaxel will be administered until disease progression or withdrawal from the study due to unacceptable toxicity. The study will proceed in two phases. The first phase (Phase I part) will lead to evaluate safety and tolerability of lapatinib taken together with paclitaxel in the first 6 subjects. Pharmacokinetic profile also will be evaluated as the secondary objects. Then the study will move to the next treatment phase (Phase II part) to evaluate further safety and clinical activity, if no major safety concerns are raised during Phase I part. The primary objective of the study is to evaluate overall survival (OS), and the secondary objectives are Objective tumour response rate (ORR), Duration of response, Time to response, Clinical benefit and Progression-free survival (PFS) in 12 subjects.
This is a Phase II, randomized, open-label, multi-center study evaluating the efficacy and safety of lapatinib in combination with chemotherapy versus trastuzumab in combination with chemotherapy in women with HER2-positive and p95HER2-positive metastatic breast cancer (MBC). Eligible subjects will have newly diagnosed metastatic breast cancer (Stage IV) either as a primary diagnosis or as a recurrence following treatment of curative intent; not have received systemic or local treatment for MBC and have breast cancer that is positive for HER2 and p95HER2. The primary objective is to compare progression-free survival (PFS) of lapatinib plus chemotherapy versus trastuzumab plus chemotherapy as first-line treatment in subjects with MBC exhibiting concurrent HER2 overexpression (and/or gene amplification) and expression of carboxy-terminal fragments of HER2 (p95HER2). The secondary objectives are to evaluate overall survival, overall response rate, clinical benefit response rate and the safety as well as tolerability of lapatinib plus chemotherapy and trastuzumab plus chemotherapy.
The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to permanent section Hematoxylin and Eosin (H&E) and IHC staining.
To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast cancer patients with positive lymph nodes
In this "randomised Phase II trial" all patients will receive carboplatin, with half randomly selected to receive ZD4054. The other half to also receive a dummy pill or placebo, this is so that we can accurately assess how much extra benefit ZD4054 may give. The trial will recruit 132 patients with metastatic breast cancer from across the UK and assess whether adding ZD4054 to carboplatin delays progression of their disease. It will also show whether the side effects of adding ZD4054 to carboplatin chemotherapy are acceptable. Because ZD4054 has not previously been given with carboplatin to this population, in Stage 1 of the study 6 patients will receive ZD4054 with carboplatin. If there are no untoward side effects with carboplatin and ZD4054 then the trial will proceed to Stage 2 and a further 126 patients will be randomised to receive carboplatin with either ZD4054 or the placebo; neither the patient nor their doctor will know whether she is receiving ZD4054 or placebo.
The purpose of this study is to learn more about how being treated for breast cancer affects patients' employment, financial situation, and quality of life on a short-term basis and on a long term basis. Most studies of employment after breast cancer have focused on Caucasian women.This study will evaluate the impact of breast cancer on the lives of women from different ethnic groups.
Primary objectives : 1. To evaluate the recommended dose of the combination of paclitaxel, gemcitabine, and lapatinib (Tykerb®) (PGT) as preoperative chemotherapy in patients with HER2 positive operable breast cancer Secondary objectives : 1. To evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of PGT 2. To determine the safety profile 3. To assess pCR in primary tumor and axillary LN 4. To evaluate clinical response rate, disease free survival (DFS), and overall survival (OS) 5. To assess breast conserving rate after preoperative PGT
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab. The study will further assess the safety and preliminary efficacy of BKM120 in combination with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast cancer and brain metastases (BM) who have previously failed trastuzumab.
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from patients with ductal breast carcinoma in situ.