Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Abraxis BioScience Inc. Beth Israel Deaconess Medical Center Massachusetts General Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00308178

Purpose

The purpose of this trial is to see if Abraxane, which is a new form of paclitaxel, is safe as a replacement form of paclitaxel in dose-dense chemotherapy. This trial will also determine if using Abraxane will allow patients to receive treatment every two weeks without requiring injects of G-CSF, a white blood cell stimulating growth factor.

Condition	Intervention
Breast Cancer	Drug: Abraxane

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Dose Dense AB1-007 (Abraxane) in Adjuvant Chemotherapy for Breast Cancer: A Feasibility Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To evaluate the feasibility and toxicity of Abraxane after chemotherapy as part of dose-dense adjuvant chemotherapy for breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the feasibility of administering Abraxane on a dose dense schedule without G-CSF support [ Time Frame: 2 years ] [ Designated as safety issue: No ]
to estimate the percentage of patients with various grades of hematologic toxicity, neurotoxicity, and other non-hematologic toxicity associated with dose-dense Abraxane [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
to evaluate quality of life. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	63
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2010
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Following 4 cycles (8 weeks) of adjuvant chemotherapy (adriamycin and cytoxan), abraxane will be give every 2 weeks for 4 cycles(8 weeks)

Detailed Description:

Patients will receive regular chemotherapy every 2 weeks for up to 8 cycles (approximately 16 weeks total)of treatment. During the first four cycles patients will be treated with Adriamycin and Cytoxan, and for the second four cycles they will be treated with Abraxane.
Patients will be taught to give themselves injections with either short or long acting G-CSF as prescribed by their doctor for the first four cycles of chemotherapy. During the last four cycles (while the patient is taking Abraxane) they will not receive G-CSF unless they have low blood counts.
If the patient has HER-2 positive breast cancer, they will also receive 52 weeks of Herceptin as part of standard cancer care and will begin to receive Herceptin at the same time they begin Abraxane (after 4 cycles of adriamycin and cytoxan treatment).
This study involves a series of Quality of Life Questionnaires that will be completed prior to beginning study treatment, then again at 2 months, 4 months, 6 months, and 1 year after starting study treatment.
The following tests and procedures will be performed at the time periods specified. Cycle 1-4 Day 1: Physical exam, vital signs, and blood tests.

Cycle 5 Day 1: Physical exam, vital signs, blood tests, RVG (measurement of heart function) and questionnaire. Cycle 6 & 7 Day 1: Physical exam, vital signs, and blood tests. Cycle 8 Day 1: physical exam, vital signs, blood tests, questionnaire. Follow-up (6 months and 1 year after cycle 1 day

1): questionnaire.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed breast cancer, with clinical stage I, II, or III disease
Must register at the beginning of adjuvant or neoadjuvant chemotherapy
18 years of age or older
ECOG performance status of 0 or 1
Normal organ and marrow function

Exclusion Criteria:

Previous cytotoxic chemotherapy or therapeutic radiation therapy for any reason
Pregnant or nursing
Receiving any other investigational agents
Patients with Stage IV breast cancer
Current grade II or greater peripheral neuropathy or prior history of grade II or greater neuropathy
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Immune deficiency when treated with marrow-suppressive therapy or HIV-positive patients receiving anti-retroviral therapy
Patients with sickle cell disease
Known history of hyperviscosity syndrome
Patients on lithium

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308178

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massacusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Dana-Farber Cancer Institute

Abraxis BioScience Inc.

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Investigators

Principal Investigator:

Harold Burstein, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Harold J. Burstein, MD )
Study ID Numbers:	05-249
Study First Received:	March 28, 2006
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00308178 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Abraxane
dose-dense chemotherapy
taxol

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Tubulin Modulators
Adjuvants, Immunologic
Breast Neoplasms

Antimitotic Agents
Cyclophosphamide
Antineoplastic Agents, Phytogenic
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Antimitotic Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009