Advertisement

Topics

Efficacy of RAD001 in Breast Cancer Patients With Bone Metastases

2014-08-27 03:38:51 | BioPortfolio

Summary

The purpose of this study is to determine wether RAD001 can inhibit growth of tumour cells and/or stop the formation and activity of bone degrading osteoclasts.

Description

RAD001 is an orally bioavailable and well tolerated rapamycin ester analogue, which acts by selectively inhibiting mTOR (mammalian target of rapamycin). mTor is an intracellular protein kinase implicated in the control of cellular proliferation in neoplastic cells. Treatment with RAD001 has been shown to inhibit these signalling events and leads to growth retardation of tumour cells. In addition RAD001 in vitro stops the formation and activity of osteoclasts. Therefore a therapy of advanced breast cancer with progressive bone metastases seems to be reasonable with RAD001.

Comparison:

All patients receive RAD001 in an 8 week run in phase. Patients who show a response after 8 weeks will continue receiving RAD001. All patients with stable disease after the run in phase will be randomised to receive either RAD001 or placebo and will be followed up until progression of disease. Patients with progressive disease after the 8 week run in phase will be withdrawn from the trial.

Study Design

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

Conditions

Breast Cancer

Intervention

RAD001, Placebo

Location

Dr. med. Christoph Mundhenke
Kiel
Schleswig-Holstein
Germany
24105

Status

Recruiting

Source

German Breast Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:51-0400

Clinical Trials [4366 Associated Clinical Trials listed on BioPortfolio]

Trial of RAD001 in Triple Negative Metastatic Breast Cancer

The hypothesis of this clinical research study is to discover if the study drug RAD001 can shrink or slow the growth of ER/PR negative or Her2 Neu negative breast cancer. The safety of RA...

Phase I Oral mTOR Inhibitor RAD001 in Combo w/ Capecitabine for Metastatic Breast

In order to improve the survival of metastatic breast patients, it is important to investigate the use of novel therapeutic agents combined with known active agents in the treatment of bre...

RAD001 Plus Carboplatin in Breast Cancer Patients

This study will investigate the effectiveness of combination of carboplatin and investigational agent RAD001 in triple-negative breast cancer.

Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer

The purpose of this research study is to determine the safety of RAD001 and the highest dose of this drug that can be given to people with HER2-positive metastatic breast cancer safely in ...

Study of Combined Fulvestrant and RAD001 in Advanced/Metastatic Breast Cancer After Aromatase Inhibitor Failure

The primary objective of this study is to determine if estrogen receptor-targeted therapy with fulvestrant used in combination with RAD001 (Everolimus) is an effective and safe therapy for...

PubMed Articles [14980 Associated PubMed Articles listed on BioPortfolio]

Combination treatment of RAD001 and BEZ235 exhibits synergistic antitumor activity via down-regulation of p-4E-BP1/Mcl-1 in small cell lung cancer.

Small cell lung cancer (SCLC) is a highly malignant cancer with few targeted therapies. In the study, by mining the Cancer Cell Line Encyclopedia (CCLE) database, we found that PI3K/AKT/mTOR pathway w...

Attenuation of everolimus-induced cytotoxicity by a protective autophagic pathway involving ERK activation in renal cell carcinoma cells.

The mammalian target of rapamycin (mTOR) pathway is a critical target for cancer treatment and the mTOR inhibitor everolimus (RAD001) has been approved for treatment of renal cell carcinoma (RCC). How...

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...

Breast cancer in octogenarian. Are we doing our best? A population-registry based study.

The number of old people with breast cancer is estimated to increase during the next years in developed countries. However, management of breast cancer in octogenarians is not well established. The ma...

Multiple primary non-breast tumors in breast cancer survivors.

The aim of this study was to assess the frequency of second primary non-breast cancer after breast cancer diagnosis and treatment, and its correlation with clinicopathological features.

Medical and Biotech [MESH] Definitions

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

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.

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)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

More From BioPortfolio on "Efficacy of RAD001 in Breast Cancer Patients With Bone Metastases"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Osteoporosis
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...

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...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial