View clinical trials related to Breast Neoplasms.
Filter by:This phase I trial studies the side effects and best dose of Akt inhibitor MK2206 and lapatinib ditosylate when given together with trastuzumab in treating patients with locally advanced or metastatic human epidermal growth factor receptor-2 (HER2)-positive breast, gastric, or gastroesophageal cancer that cannot be removed by surgery. Akt inhibitor MK2206 and lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving Akt inhibitor MK2206 and lapatinib ditosylate together with trastuzumab may kill more tumor cells.
This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design, followed by a randomized, open-label Phase 2 part to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in participants with mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, withdrawal of consent, or study end.
This is a therapeutic exploratory Phase 2 study evaluating AEZS-108 compared to standard single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free survival (PFS) in patients with chemotherapy refractory triple negative (ER/PR/HER2-negative) LHRH-R positive metastatic breast cancer.
This phase I/II trial studies the side effects and the best dose of triciribine phosphate when given together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide and to see how well they work in treating patients with stage IIB-IV breast cancer. Triciribine phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving triciribine phosphate with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide may be a better treatment for breast cancer.
The GALADON trial is a diagnostic and interventional study in which different molecular imaging methods as Positon Emission Tomography (PET), different kind of Magnetic Resonance Imaging - methods (MRI, DWI and DCE-MRI) will be compared with common imaging methods (mammography, ultrasound) to see if there can detect an early response to a combined neoadjuvant therapy with bevacizumab and docetaxel in patients with locally advanced breast cancer. Neoadjuvant chemotherapy (this means patients were treated before the tumor was removed by surgery) with a drug like trastuzumab (monoclonal antibody) which is target to the Her2-protein is much more powerful than with chemotherapy alone because it is normalizing the blood supply and improves tumor delivery of conventional chemotherapy like docetaxel. The HER2 protein is only available in about 30 % of breast cancer types. bevacizumab is another humanized monoclonal antibody like trastuzumab but is effective not only in patients with an positive HER2 status and in combination with trastuzumab it may emphasize the effect in reduction of tumor growth. Bevacizumab is approved in advanced disease, but no major neoadjuvant data available so far for primary breast cancer. As the therapy with monoclonal antibody regimes are expensive and may cause severe side effects predictive factors to select patients who will benefit from such highly specific drugs before therapy start would be medically and economically highly valuable. In this study the efficacy of combined neoadjuvant chemotherapy with bevacizumab, trastuzumab and docetaxel in Arm A and bevacizumab and docetaxel in Arm B should be evaluated and the predictive impact of different imaging methods for tumor response should be shown.
This study is investigating the effects of a new hormone treatment for breast cancer called Irosustat. Seventy percent of breast cancers in post-menopausal wome rely on oestrogen to grow therefore are likely to respond to hormone therapy. Irosustat blocks a different pathway of steroid synthesis to Aromatase, reducing in this way oestrogen levels in the body. As less oestrogen reaches the breast cancer, it grows more slowly or stops growing altogether. IPET will recruit postmenopausal women with early, hormone sensitive, treatment naive breast cancer will receive 40mg of Irosustat once daily for 2 weeks. The effects of Irosustat on breast cancer will be evaluated by PET scans (Positron Emission Tomography) using a radioactive substance called FLT as a tracer. The scans will be performed in a PET-CT scanner which combines a PET scan and a CT scan (Computer Tomography) into one scan. This type of scan can show how body tissues are working, as well as what they look like. FLT-PET scans will be performed before and following treatment with Irosustat. As cancer cells grow faster than the normal cells around them, they will take up more of the radioactive substance, and so stand out clearly on the scan. If Irosustat is slowing down the cancer growth, the cancer will take up less of the tracer. Blood samples will be taken at regular intervals to assess what the new drug does to the body and the safety and tolerability of Irosustat will be assessed. The study incorporates translation aspects/endpoints which are based on the collection of tumour biopsies before and after treatment with Irosustat although the later biopsy is not mandatory.
Objectives: Phase I part - Primary Objective: To determine the recommended dose of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer. - Secondary Objectives:To define the safety profile; To observe the response rate and progression free survival Phase II part - Primary Objective :To determined the objective response rate of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer. - Secondary Objectives:To define the safety profile; To determined the progression free survival
Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.
This study is a randomized prospective clinical trial of women with metastatic breast cancer. The purpose of the study is to test if an intervention of regular physical activity review and physical activity goal setting will allow the subjects to achieve a moderate increase in physical activity of 6,000 steps per week. The physical activity review will consist of weekly telephone call to inquire about symptoms and to set physical activity goals. The study will also look to see if the goal setting intervention will affect the time to progression, change in BMI, and quality of life. Quality of life will be measured by answers to questionnaires provided to subjects at regular intervals during the course of the study. Finally, the study will examine the impact of physical activity on expression of tumor molecular molecules, insulin levels, and estradiol levels. Through an intervention of regular physical activity review and goal setting, the investigators hypothesize that a moderate increase in level of physical activity of 6000 steps per week or more can be obtained by patients with metastatic breast cancer who receive a goal setting intervention. The investigators propose that those who are able to achieve and maintain greater than or equal to 22500 steps per week will demonstrate biologic and molecular differences compared to those who are not able to achieve that level of physical activity. The investigators expect that people who are more active will have longer to progression.
This clinical trial studies how well fosaprepitant dimeglumine and granisetron transdermal system work in preventing nausea and vomiting in patients with breast cancer undergoing chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy