Paclitaxel or Docetaxel in Treating Women With Advanced 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: NCT00002662
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel is more effective than docetaxel for breast cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer.

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

Detailed Description:


  • Compare the response rate in women with metastatic or locally advanced, inoperable adenocarcinoma of the breast treated with docetaxel vs paclitaxel.
  • Compare the toxicity of these regimens in these patients.
  • Compare the time to disease progression, duration of response, quality of life, and survival of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after courses 4 and 6.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 1994
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 proven metastatic or locally advanced, inoperable adenocarcinoma of the breast

    • Clinically evident metastases (e.g., clearly malignant lesions on chest x-ray or CT or abdominal CT do not require histologic confirmation)
    • Hot spots on bone scan not shown to be malignant on plain x-rays are not adequate evidence of malignant disease in the absence of other lesions
  • Must meet 1 of the following conditions:

    • Disease progression after 1 prior chemotherapy regimen for locally advanced or metastatic disease (which may or may not have followed a separate adjuvant regimen using chemotherapy or hormonal therapy)
    • Locally advanced or metastatic disease during or after 1 adjuvant or neoadjuvant chemotherapy regimen
    • One of the above chemotherapy regimens must have contained an anthracycline (e.g., doxorubicin, but not mitoxantrone)
    • Single drug substitution (e.g., methotrexate for doxorubicin) during prior combination chemotherapy allowed
  • Bidimensionally measurable
  • No clinical or radiographic evidence of brain or leptomeningeal disease
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 60-100% OR
  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute neutrophil count at least 2,000/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin normal
  • SGOT no greater than 2.5 times upper limit of normal


  • Creatinine no greater than 2.0 mg/dL
  • No uncontrolled hypercalcemia


  • No myocardial infarction within the past 6 months
  • No history of arrhythmia requiring treatment
  • No heart block
  • No clinical evidence of congestive heart failure
  • No unstable angina (e.g., new onset, crescendo, or rest angina)
  • Stable exertional angina allowed


  • No current symptomatic grade 2 or greater peripheral neuropathy
  • No history of hypersensitivity to products containing Cremophor EL (e.g., cyclosporine or teniposide) or Polysorbate 80 (e.g., IV etoposide)
  • No serious infection
  • No significant psychiatric disease that would preclude study
  • No other malignancy within the past 5 years except nonmelanomatous skin cancer or completely excised carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • No prior bone marrow or stem cell transplantation


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (2 weeks for oral cyclophosphamide or 6 weeks for nitrosoureas or mitomycin)
  • No prior high-dose chemotherapy given with ablative intent
  • No prior taxoids
  • No other concurrent antineoplastic therapy

Endocrine therapy:

  • See Disease Characteristics
  • Prior hormonal therapy as adjuvant therapy or for metastatic disease allowed
  • At least 1 week since prior hormonal therapy
  • No concurrent corticosteroids except:

    • Prophylaxis or treatment for acute hypersensitivity reactions
    • Chronic therapy (more than 6 months) at low doses (20 mg/day or less of methylprednisolone or equivalent)


  • At least 4 weeks since prior radiotherapy to major bone marrow areas
  • No prior high-dose radiotherapy given with ablative intent
  • No concurrent radiotherapy except limited palliative radiotherapy (e.g., for a solitary rib fracture) during objective response


  • See Disease Characteristics
  • More than 2 weeks since prior surgery except simple biopsy or placement of venous access device


  • At least 4 weeks since prior investigational drugs
  • Concurrent medications known to alter cardiac conduction (e.g., digoxin, beta blockers, or calcium channel blockers) allowed
  • No concurrent ketoconazole
  • No concurrent bisphosphonates unless initiated more than 3 months before randomization
  • No concurrent experimental drug or therapy

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): NCT00002662

  Show 32 Study Locations
Sponsors and Collaborators
Aventis Pharmaceuticals
Study Chair: Peter M. Ravdin, MD The University of Texas Health Science Center at San Antonio Identifier: NCT00002662     History of Changes
Other Study ID Numbers: AVENTIS-56976-TAX-311
CDR0000064232 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: April 2004

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action