Advertisement

Topics

A Study to Look at the Combination of Chemotherapy, Trastuzumab and RAD001 in HER2 Positive Breast Cancer

2014-08-27 03:12:10 | BioPortfolio

Summary

The primary objective of this study is to assess whether a combination of chemotherapy, Trastuzumab and RAD001 will result in no evidence of microscopic disease at the time of surgery in 50% of enrolled patients.

Description

This is an open-label Phase 2 neoadjuvant study for patients with histologically confirmed, HER-2 positive operable breast cancer. All patients will receive 18 weeks of neoadjuvant treatment.

The trial has an initial 2 week "biomarker lead in" phase. During this two week phase patients will either receive Trastuzumab alone or Trastuzumab + Everolimus. This two week lead in phase will be randomized open label. The rest of the 16 weeks of the neoadjuvant trial treatment is non randomized open label.

For the first two weeks of neoadjuvant treatment the eligible subjects will be randomly assigned to either receive or not receive Everolimus. This assignment will be accomplished by a previously prepared schedule (maintained by the investigational pharmacy), such that investigators are unaware of assignment until after the subject has been enrolled on the study and received assignment of Everolimus or not.

Study Design

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

Conditions

Breast Cancer

Intervention

paclitaxel

Location

University of Kansas Medical Center
Kansas City
Kansas
United States
66160

Status

Recruiting

Source

University of Kansas

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:10-0400

Clinical Trials [5417 Associated Clinical Trials listed on BioPortfolio]

A Randomized Trial Comparing Epirubicin/Cyclophosphamide Followed by Weekly Paclitaxel Versus Epirubicin/Paclitaxel Followed by Weekly Paclitaxel as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old

Manifold data revealed that young breast cancer patients are characterized by aggressive clinical history. The purpose of this study is to evaluate the efficacy and safety of different str...

Cyclosporine A in Combination With Nab-Paclitaxel in Patients With Metastatic Breast Cancer

The purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer cells as...

Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel is more effective than doceta...

Improved Breast Cancer Therapy (I-BCT-1) in the Neoadjuvant and Metastatic Setting

The purpose of the study is to investigate the molecular biology of the tumor in relation to treatment response to chemotherapy, in particular paclitaxel compared to the combination paclit...

A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer

PubMed Articles [14112 Associated PubMed Articles listed on BioPortfolio]

Low doses of Paclitaxel repress breast cancer invasion through DJ-1/KLF17 signaling pathway.

Paclitaxel (taxol) is an important agent against many tumors, including breast cancer. Ample data documents that paclitaxel inhibits breast cancer metastasis while others prove that paclitaxel enhance...

Isobavachalcone sensitizes cells to E2-induced paclitaxel resistance by down-regulating CD44 expression in ER+ breast cancer cells.

Oestrogen receptor (ER) is expressed in approximately 60%-70% of human breast cancer. Clinical trials and retrospective analyses have shown that ER-positive (ER+) tumours are more tolerant to chemothe...

Significant Association Between Low Baseline Neutrophil-to-Lymphocyte Ratio and Improved Progression-free Survival of Patients With Locally Advanced or Metastatic Breast Cancer Treated With Eribulin But Not With Nab-Paclitaxel.

Although eribulin and nab-paclitaxel are chemotherapy agents widely used for locally advanced or metastatic breast cancer (MBC), their predictive factors remain unknown. Because the absolute neutrophi...

Mesenchymal stem cells drive paclitaxel resistance in ErbB2/ErbB3-coexpressing breast cancer cells via paracrine of neuregulin 1.

We had previously demonstrated that increased expression of ErbB3 is required for ErbB2-mediated paclitaxel resistance in breast cancer cells. In the present study, we have explored the possible role ...

Knockdown of lncRNA H19 restores chemo-sensitivity in paclitaxel-resistant triple-negative breast cancer through triggering apoptosis and regulating Akt signaling pathway.

Triple negative breast cancer (TNBC) is associated with poor prognosis and systemic chemotherapy is the only treatment for TNBC. However, development of chemo-resistance remains a major obstacle for T...

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 "A Study to Look at the Combination of Chemotherapy, Trastuzumab and RAD001 in HER2 Positive Breast Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Searches Linking to this Trial