Docetaxel in Treating Patients With Metastatic 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: NCT00008411
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 30, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Phase 3

Detailed Description:


  • Compare the objective tumor response rate, duration of response, time to progression, progression-free survival, and overall survival in women with metastatic breast cancer treated with docetaxel administered weekly vs every three weeks.
  • Compare the safety and toxicity of these regimens in these patients.
  • Evaluate the maintenance of relative dose intensity with each regimen in these patients.
  • Correlate pretreatment serum HER2/neu level and response with docetaxel therapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior taxane use (yes vs no), number of prior chemotherapy regimens for metastatic disease (0 vs 1), and participating center. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
  • Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.

Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks, at 3, 6, 9, and 12 months, and then annually for 4 years.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study Comparing the Use of Docetaxel on a Every Three-Week vs. Weekly Schedule in the Treatment of Patients With Metastatic Breast Cancer
Study Start Date : December 1999
Actual Primary Completion Date : March 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Docetaxel Weekly
Arm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
Drug: Docetaxel
35 mg/m2 IV over 30 minutes on days 1, 8, and 15, for 3 weeks followed by one week of rest repeated every 28 days.
Other Name: Taxotere

Experimental: Docetaxel Every 3 Weeks
Arm II: Docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.
Drug: Docetaxel
Every 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days.
Other Name: Taxotere

Primary Outcome Measures :
  1. Objective Tumor Response Rate [ Time Frame: Weekly ]

Information from the National Library of Medicine

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


  • Histologically confirmed metastatic breast cancer
  • Bidimensionally measurable disease
  • No uncontrolled brain metastases or leptomeningeal disease
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 3 months


  • Platelet count at least 100,000/mm^3
  • Neutrophil count at least 1,000/mm^3
  • Hemoglobin at least 8 g/dL


  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT/SGPT no greater than 1.5 times ULN (2.5 times ULN provided alkaline phosphatase no greater than ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN provided transaminases no greater than ULN)


  • Creatinine no greater than 2.0 mg/dL


  • No peripheral neuropathy grade 2 or greater
  • Neurologic status must be stable 2 weeks after surgery and/or radiotherapy for brain metastasis
  • No psychiatric disorders


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated malignancy
  • No other serious condition or illness, including active infection
  • No history of hypersensitivity to polysorbate 80


Biologic therapy:

  • Not specified


  • Recovered from prior chemotherapy
  • No more than 2 prior chemotherapy regimens (no more than 1 prior regimen for metastatic disease)
  • No prior paclitaxel or docetaxel (except in the adjuvant setting)
  • At least 12 months since prior adjuvant taxane (paclitaxel or docetaxel)
  • Prior anthracycline-based therapy allowed

Endocrine therapy:

  • Not specified


  • At least 2 weeks since prior radiotherapy and recovered


  • At least 2 weeks since prior surgery and recovered

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): NCT00008411

United States, Texas
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Edgardo Rivera, MD M.D. Anderson Cancer Center

Additional Information:
Publications of Results:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00008411     History of Changes
Other Study ID Numbers: ID99-242
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-ID-99242 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000068408 ( Registry Identifier: NCI PDQ )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action