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

March 28, 2006
February 15, 2013
March 2006
September 2006   (final data collection date for primary outcome measure)
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 ]
To evaluate the feasibility and toxicity of Abraxane after chemotherapy as part of dose-dense adjuvant chemotherapy for breast cancer.
Complete list of historical versions of study NCT00308178 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To evaluate the feasibility of administering Abraxane on a dose dense schedule without G-CSF support
  • to estimate the percentage of patients with various grades of hematologic toxicity, neurotoxicity, and other non-hematologic toxicity associated with dose-dense Abraxane
  • to evaluate quality of life.
Not Provided
Not Provided
 
Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer
Dose Dense AB1-007 (Abraxane) in Adjuvant Chemotherapy for Breast Cancer: A Feasibility Study

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.

  • 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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
June 2008
September 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00308178
05-249
Not Provided
Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
Harold J. Burstein, MD, PhD
  • Celgene Corporation
  • Beth Israel Deaconess Medical Center
  • Massachusetts General Hospital
Principal Investigator: Harold Burstein, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP