View clinical trials related to Metastatic Breast Cancer.
Filter by:To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered
The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer.
The course of the disease in female patients with metastatic mammary carcinoma can vary greatly. In this connection, the individual prognosis depends on a complex interaction of tumor- and patient-related factors. To take account of such differences, it is necessary to employ individual methods of treatment which are suited to the course of each patient's disease. Prof. Possinger and Dr. Schmid (Charite Berlin) and Prof. Wischnewsky (University of Bremen) have developed an approach that can help to achieve this goal with the aid of computerized machine learning techniques (MLT). The use of machine learning methods can be beneficial in oncology in two respects. On the one hand, an attempt can be made to individually estimate clinically relevant parameters like, for example, the recurrence probability or expected survival time as precisely as possible based on the established prognostic factors. And on the other hand, it may be possible with the aid of MLT to understand structural relationships between the clinical result and measured or established tumor-/patient-related variables. To analyze the possible benefits of machine learning techniques for patients with metastatic breast cancer, the aim of study FEM-D-2 is to investigate whether it is possible to characterize those patients who either do or do not respond to a specific treatment with a precision of 90%, prospectively estimate the time until worsening of the disease under a given treatment, and classify patients in groups with favorable and poor chances of medium-term survival. The use of inductive learning algorithms with machine learning also makes it possible to very accurately estimate the time until progression of the tumor growth. In patients who respond to letrozole therapy, the time until tumor progression depends on factors like pain, age, body mass index, disease-free interval, main localization of metastatic spread, and response to previous estrogen therapy. Only very minimal differences are found when comparing the actual time until progression of the disease and that calculated by the system (at least for survival times < 1 year). Furthermore, using machine learning techniques it has become possible to use initial data assessed before a letrozole treatment to estimate the survival time and distinguish patients with a high risk of dying soon from other patients with a more favorable prognosis.
The purpose of this study is to determine if acquired hormone therapy resistance can be reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate toxicity of the combination of hormone treatment plus Avastin (Bevacizumab).
Two thirds or more of breast cancers are dependent on estrogen for growth. We use a number of estrogen-blocking medicines for treatment of metastatic breast cancer. The treatment response to these agents is unpredictable, however, and approximately one-third of patients with metastatic breast cancer with receptors for estrogen or progesterone have no benefit from hormonal therapy. Nearly all patients with metastatic breast cancer will eventually become resistant to hormonal therapy despite the fact that the hormone receptors are still present. Some cells make a different class of growth factor receptor called the Epidermal Growth Factor Receptor. There is a growing body of experimental evidence showing that breast cancer cells that make Epidermal Growth Factor Receptors are more resistant to hormonal therapy and have a poorer prognosis. Several investigators have found that the Epidermal Growth Factor Receptor can activate the estrogen receptor, even in the presence of estrogen-blocking drugs. Growth of these cells can be slowed by blockade of both Epidermal Growth Factor Receptor signaling and estrogen-receptor signaling. Lapatinib is a small molecule which can inhibit two different forms of the Epidermal Growth Factor Receptor. It has been studied in people with a number of different cancers, including breast cancer, and a safe dose and its common side effects have been defined. Our hypothesis is that the Epidermal Growth Factor Receptor is the dominant receptor pathway used by breast cancers in our patients with hormone-resistant tumors. Drugs like lapatinib which block several forms of the Epidermal Growth Factor Receptor would best be able to reverse resistance to hormonal agents.
In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.
In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to surrounding normal tissue. Trastuzumab is synergistic in vitro with multiple chemotherapeutic agents including the platinum compounds. Studies have shown the efficacy of trastuzumab combined with chemotherapy in patients with HER2 overexpressing metastatic breast cancer. This trial will investigate the activity of capecitabine and oxaliplatin administered with trastuzumab (CAPOX-T) in patients with HER2 overexpressing in patients with advanced disease.
In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to surrounding normal tissue. This trial will investigate the activity of this novel capecitabine/oxaliplatin (CAPOX) combination in patients with advanced disease. In addition, an exploratory analysis will correlate response with thymidine synthase and thymidine phosphorylase expression in primary tumor samples.
The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.
Patients with locally advanced or metastatic breast cancer and with measurable primary breast tumor will be treated with 70mg docetaxel combined with ketoconazole. Serial tumor biopsies and plasma samples will be taken for gene expression and proteomics studies to identify biomarkers that may predict for treatment response.