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Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer

2014-08-27 03:15:05 | BioPortfolio

Summary

The purpose of this clinical trial is to test whether treatment of patients with breast cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24 patients may be enrolled in this study at the Mitchell Cancer Institute. All patients enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin, and Cyclophosphamide.

Description

This is a single center, open phase I dose escalation study. This study will assess the highest tolerable dose of nab-paclitaxel (Abraxane) in combination with doxorubicin (Adriamycin) and cyclophosphamide in patients with stages II-III breast cancer in the neoadjuvant setting. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination. Up to 24 patients will be enrolled.

The study will test four dose levels of Abraxane as described in Table 2, with fixed dose of doxorubicin (50 mg/m2 weekly) and cyclophosphamide (500 mg/m2). For each cycle, Abraxane will be administered based on the dose schedule in Table 2. Adriamycin and Cyclophosphamide will be given on day 1 and day 22 of each cycle. Each cycle will be repeated every 6 weeks. The study will enroll patients with stages II-III, Her-2 negative breast cancer with no prior therapy. Patients will be treated for 3 six-week cycles, for a total of 18 weeks.

Study Design

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

Conditions

Stages II-III Breast Cancer

Intervention

Nanoparticle Albumin Bound Paclitaxel, doxorubicin, cyclophosphamide

Location

University of South Alabama Mitchell Cancer Institute
Mobile
Alabama
United States
36604

Status

Recruiting

Source

University of South Alabama

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:05-0400

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Medical and Biotech [MESH] Definitions

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

A condition in which albumin level in blood (SERUM ALBUMIN) is below the normal range. Hypoalbuminemia may be due to decreased hepatic albumin synthesis, increased albumin catabolism, altered albumin distribution, or albumin loss through the urine (ALBUMINURIA).

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.

A topical glucocorticoid used in various DERMATOSES. It is absorbed through the skin, bound to plasma albumin, and may cause adrenal suppression. It is also administered as the valerate.

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