NCT00308178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

6 months

First QC Date

March 28, 2006

Last Update Submit

February 15, 2013

Conditions

Breast Cancer

Keywords

Abraxanedose-dense chemotherapytaxol

Outcome Measures

Primary Outcomes (1)

  • To evaluate the feasibility and toxicity of Abraxane after chemotherapy as part of dose-dense adjuvant chemotherapy for breast cancer.

    2 years

Secondary Outcomes (3)

  • To evaluate the feasibility of administering Abraxane on a dose dense schedule without G-CSF support

    2 years

  • to estimate the percentage of patients with various grades of hematologic toxicity, neurotoxicity, and other non-hematologic toxicity associated with dose-dense Abraxane

    2 years

  • to evaluate quality of life.

    2 years

Interventions

AbraxaneDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massacusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Harold Burstein, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 29, 2006

Study Start

March 1, 2006

Primary Completion

September 1, 2006

Study Completion

June 1, 2008

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

US(3)