Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Celgene Corporation
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00308178
First received: March 28, 2006
Last updated: February 15, 2013
Last verified: February 2013
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Dense AB1-007 (Abraxane) in Adjuvant Chemotherapy for Breast Cancer: A Feasibility Study

Resource links provided by NLM:


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 ]

Enrollment: 66
Study Start Date: March 2006
Study Completion Date: June 2008
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Harold J. Burstein, MD, PhD
Celgene Corporation
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: Harold J. Burstein, MD, PhD, Associate Professor of Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00308178     History of Changes
Other Study ID Numbers: 05-249
Study First Received: March 28, 2006
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Abraxane
dose-dense chemotherapy
taxol

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014