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S0029 Docetaxel in Treating Older Women 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: NCT00025493
Recruitment Status : Terminated (poor accrual)
First Posted : January 27, 2003
Last Update Posted : January 24, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

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

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating older women who have metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel Phase 2

Detailed Description:


  • Determine the feasibility of treating elderly women with metastatic breast cancer with docetaxel.
  • Determine the overall survival, 2-year survival, and response (confirmed and unconfirmed complete and partial) in patients treated with this drug.
  • Determine the toxicity and tolerability of this drug in these patients.
  • Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in elderly cancer patients.
  • Determine the parameters of clinical pharmacology of this drug in elderly patients and in patients under 60 years of age.
  • Determine, preliminarily, the genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance in patients treated with this drug.

OUTLINE: Patients are stratified according to age (70 and over vs under 60).

Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 3 years.

PROJECTED ACCRUAL: Approximately 80 patients (60 patients age 70 and over and 20 patients under age 60) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger Than 60 Years)
Study Start Date : October 2001
Primary Completion Date : June 2007
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: docetaxel
Drug: docetaxel

Primary Outcome Measures :
  1. Study treatment feasibility [ Time Frame: monthly for duration of accrual ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: at weeks 10 and 19, then every 3 months for 3 years ]
  2. Survival at 2 years [ Time Frame: at weeks 10 and 19, then every 3 months for 2 years ]
  3. Response rate (confirmed and unconfirmed complete and partial response) [ Time Frame: at weeks 10 and 19, then every 3 months for 3 years ]
  4. Toxicity and tolerability [ Time Frame: at week 1, then every 3 weeks ]
  5. Feasibility of standardized self-report measures of comorbidity, depression, and functional status [ Time Frame: upon completion of patient accrual ]
  6. Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age [ Time Frame: upon completion of patient accrual ]

Information from the National Library of Medicine

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


  • Histologically confirmed breast cancer

    • Distant metastatic disease confirmed by histology, cytology, or strong clinical evidence
  • Measurable disease
  • No known brain or CNS metastases
  • Hormone receptor status:

    • Not specified



  • 70 and over OR
  • Under 60


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


  • Absolute granulocyte count at least 1,500/mm^3
  • Hemoglobin at least 9 g/dL
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT or SGPT no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present)
  • Alkaline phosphatase no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present)


  • Creatinine no greater than ULN


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission


Biologic therapy:

  • No concurrent immunotherapy for breast cancer


  • Prior adjuvant or neoadjuvant chemotherapy allowed
  • Prior adjuvant taxanes allowed
  • No other concurrent chemotherapy for breast cancer

Endocrine therapy:

  • Prior hormonal therapy in the adjuvant setting or for metastatic disease allowed
  • No concurrent hormonal therapy for breast cancer


  • No concurrent radiotherapy for breast cancer


  • Not specified


  • No more than 1 prior regimen for advanced, recurrent, or metastatic disease

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): NCT00025493

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Silvana Martino, DO John Wayne Cancer Institute

Responsible Party: Southwest Oncology Group Identifier: NCT00025493     History of Changes
Other Study ID Numbers: CDR0000068966
U10CA032102 ( U.S. NIH Grant/Contract )
S0029 ( Other Identifier: SWOG )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Southwest Oncology Group:
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