Advertisement

Topics

Evaluation of the Safety and Efficacy of THL-P in Metastatic Breast Cancer

2014-08-27 03:19:23 | BioPortfolio

Summary

The purpose of this study is to obtain evidence from test article with efficacy in Metastatic Breast Cancer patients. The average of all changes from baseline to post-treatment evaluations in global health/quality of life (QoL) subscale assessed by self-administered European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30).

Description

The test article is extracted from many natural herbals, in which most or their components have been shown to have anti-tumor activity. A study in 2004 showed the test article could have strong immunomodulatory effect on the antigen-stimulated proliferation response (PR) of peripheral blood mononuclear cells (PBMC) and T-cells from recurrent aphthous ulcerations (RAU) patients and suggested that it might be a potential immunoceutical agent for treatment of RAU. Subsequent study in 2005 also suggested the test article as a potential immunoceutical agent for treatment of RAU because the result showed it could modulate the antigen-stimulated cytokine production by T-cells isolated from RAU patients. Another study in 2005 showed the test article also had a broad-range tumor killing function and provided a molecular basis underlying therapeutic activity. It was also suggested in this study will could be a potential and promising cancer therapeutic or preventive agent.

The aim of this current study is to explore the safety and efficacy of the investigational product with 20 ml, 3 times per day (daily dose: 60 ml) for a total of 24 weeks in the patients with metastatic breast cancer refractory to conventional treatment modalities.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Metastatic Breast Cancer

Intervention

THL-P

Location

National Taiwan University Hospital
Taipei City
Taiwan
110

Status

Recruiting

Source

Taiwan THL Co.LTd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:23-0400

Clinical Trials [6228 Associated Clinical Trials listed on BioPortfolio]

Advanced Breast Cancer and Lifestyle Exercise Study

About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer become secondarily metastatic.Thanks to recent therapeutic advances, the median survival ranges...

Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer

RATIONALE: Studying samples of blood from patients with metastatic breast cancer in the laboratory may help doctors identify biomarkers related to breast cancer and learn more about how br...

First Line Metastatic Breast Cancer Treatment (ESMERALDA)

The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra tox...

Understanding Value in Metastatic Breast Cancer

The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this obje...

A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

BZL 101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family. Preclinical studies suggest that this herb has antitumor activity for breast cancer and prelimi...

PubMed Articles [14673 Associated PubMed Articles listed on BioPortfolio]

Morbidity of local therapy for locally advanced metastatic breast cancer: an analysis of the Surveillance, Epidemiology, and End Results (SEER)-Medicare Registry.

Limited data exist to guide the management of in-breast tumors that can produce physical and emotional discomfort in the setting of metastatic disease. We evaluated the morbidity of local therapy (LT)...

Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial.

The investigation of exercise training in metastatic breast cancer has received minimal attention. This study determined the feasibility and safety of aerobic training in metastatic breast cancer.

Variation in guideline-concordant care for elderly patients with metastatic breast cancer in the United States.

Prior studies have identified shortcomings in the quality of care for early-stage breast cancer. Guidelines recommend systemic therapy for metastatic breast cancer (MBC), but few studies have examined...

Score for the Survival Probability in Metastasis Breast Cancer: A Nomogram-Based Risk Assessment Model.

Survival of metastatic breast cancer patient remains unknown and varies greatly from person to person. Thus, we aimed to construct a nomogram to quantify the survival probability of patients with meta...

The Significance of the Stromal Response in Breast Cancer: An Immunohistochemical Study of Myofibroblasts in Primary and Metastatic Breast Cancer.

Gene expression profiling of breast cancer has demonstrated the importance of stromal response in determining the prognosis of invasive breast cancer. The host response to breast cancer is of increasi...

Medical and Biotech [MESH] Definitions

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

An estrogen responsive cell line derived from a patient with metastatic human breast ADENOCARCINOMA (at the Michigan Cancer Foundation.)

A synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE. Goserelin is used in treatments of malignant NEOPLASMS of the prostate, uterine fibromas, and metastatic breast cancer.

A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)

More From BioPortfolio on "Evaluation of the Safety and Efficacy of THL-P in Metastatic Breast Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...


Searches Linking to this Trial