Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308178
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : February 18, 2013
Celgene Corporation
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Abraxane Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Dense AB1-007 (Abraxane) in Adjuvant Chemotherapy for Breast Cancer: A Feasibility Study
Study Start Date : March 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Intervention Details:
  • Drug: Abraxane
    Following 4 cycles (8 weeks) of adjuvant chemotherapy (adriamycin and cytoxan), abraxane will be give every 2 weeks for 4 cycles(8 weeks)

Primary Outcome Measures :
  1. To evaluate the feasibility and toxicity of Abraxane after chemotherapy as part of dose-dense adjuvant chemotherapy for breast cancer. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To evaluate the feasibility of administering Abraxane on a dose dense schedule without G-CSF support [ Time Frame: 2 years ]
  2. 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 ]
  3. to evaluate quality of life. [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308178

United States, Massachusetts
Massacusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Harold J. Burstein, MD, PhD
Celgene Corporation
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Principal Investigator: Harold Burstein, MD Dana-Farber Cancer Institute

Responsible Party: Harold J. Burstein, MD, PhD, Associate Professor of Medicine, Dana-Farber Cancer Institute Identifier: NCT00308178     History of Changes
Other Study ID Numbers: 05-249
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013

Keywords provided by Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute:
dose-dense chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action