Advertisement

Topics

Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

2014-08-27 03:14:07 | BioPortfolio

Summary

The purpose of this study is to test the safety and benefit of two new drugs for the treatment of breast cancer. The patient is eligible for the study because their breast cancer has grown in spite of standard treatment. The two drugs tested in the study, Neratinib and Temsirolimus, will be given together. Also, this study will help the investigators learn why therapy directed against HER2 sometimes stops working.

Description

Phase I Design

A standard, 3+3, dose escalation schedule will be used. Between 6 and 12 patients will likely be necessary to determine the MTD of temsirolimus in combination with neratinib. There will be no intrapatient dose escalation. The starting dose of temsirolimus is 8 mg administered intravenously weekly (dose level 1). Three patients will initially be enrolled in each cohort.

Phase II Design

The phase II portion of this trial will be comprised of two cohorts—HER2-amplified and triple negative breast cancer—each of which has a Simon two-stage design to determine the efficacy of temsirolimus when administered in combination with neratinib. Both pathologic subtypes of patients will be studied separately though accrual will be simultaneous. Response (RECIST criteria) will be assessed every 8 weeks (every 2 cycles) after the start of therapy.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

Temsirolimus plus Neratinib

Location

Memorial Sloan-Kettering at Basking Ridge
Basking Ridge
New Jersey
United States
07920

Status

Recruiting

Source

Memorial Sloan-Kettering Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:07-0400

Clinical Trials [4204 Associated Clinical Trials listed on BioPortfolio]

Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer

This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination thera...

Study Evaluating Neratinib in Combination With Temsirolimus in Subjects With Solid Tumors

The primary purpose of this study is to identify the maximum tolerated dose(s) of neratinib in combination with temsirolimus in subjects with solid tumors. This study will also include a ...

Study Evaluating the Effects of Neratinib in Women With Early Stage Breast Cancer

The purpose of this study is to investigate whether neratinib can reduce the risk of previously diagnosed HER-2 positive breast cancer from returning after treatment with trastuzumab.

A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer

This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer . The interventions involved in this study are:...

Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer

This is a phase I study. The purpose of this study is to test the safety of the study drug neratinib in combination with a standard chemotherapy drug called capecitabine at different doses...

PubMed Articles [14087 Associated PubMed Articles listed on BioPortfolio]

Tyrosine kinase inhibitors for brain metastases in HER2-positive breast cancer.

Approximately 30-50% of advanced HER2-positive breast cancer patients will develop central nervous system (CNS) metastases, with an annual risk of around 10%, and a half of them will die from brain pr...

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.

Urinary Phthalate Metabolite Concentrations and Breast Cancer Incidence and Survival following Breast Cancer: The Long Island Breast Cancer Study Project.

Phthalates, known endocrine disruptors, may play a role in breast carcinogenesis. Few studies have examined phthalates in relation to breast cancer (BC), and, to our knowledge, none have considered su...

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 "Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...


Searches Linking to this Trial