We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00104624
Recruitment Status : Terminated (Toxicity issues)
First Posted : March 4, 2005
Last Update Posted : September 4, 2013
Information provided by (Responsible Party):

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel Procedure: quality-of-life assessment Phase 2

Detailed Description:



  • Determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by Lawton's Instrumental Activities of Daily Living Scale, in older women with metastatic adenocarcinoma of the breast treated with docetaxel.


  • Determine the response rate in patients treated with this drug.
  • Determine overall and progression-free survival of patients treated with this drug.
  • Determine the degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale, in patients treated with this drug.
  • Determine mood status, as measured by the Geriatric Depression Scale, of patients treated with this drug.
  • Determine toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV on days 1 and 15. Treatment repeats every 28 days for 6 courses.

Ability to perform daily activities is assessed periodically.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70
Study Start Date : May 2005
Primary Completion Date : July 2007
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months

Secondary Outcome Measures :
  1. Response rate
  2. Overall survival
  3. Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale
  4. Progression-free survival
  5. Mood status as measured by the Geriatric Depression Scale
  6. Toxicity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the breast

    • Metastatic disease
  • Measurable disease by CT scan or MRI
  • Requires first-line chemotherapy for metastatic disease
  • Hormone receptor status:

    • Not specified



  • 70 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • Meets both of the following criteria:

    • Lawton's Instrumental Activities of Daily Living score ≥ 4
    • Katz's Activities of Daily Living score ≥ 4

Life expectancy

  • More than 3 months


  • Hemoglobin > 10 g/dL
  • Neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3


  • ALT and AST < 1.5 times normal
  • Bilirubin normal
  • Alkaline phosphatase < 2.5 times normal


  • Creatinine clearance > 30 mL/min


  • No congestive heart failure
  • No unstable angina pectoris
  • No myocardial infarction within the past year
  • No uncontrolled hypertension
  • No high-risk uncontrolled arrhythmias


  • Geriatric Depression Score < 12
  • No active uncontrolled infection
  • No active peptic ulcer
  • No uncontrolled diabetes mellitus
  • No inflammatory bowel disease
  • No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80
  • No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent
  • No familial, social, geographical, or psychological condition that would preclude study follow-up
  • No definite contraindication to corticosteroids
  • No other serious illness or medical condition
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix


Biologic therapy

  • No prior or concurrent trastuzumab (Herceptin^®)


  • Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed
  • More than 2 years since prior docetaxel or paclitaxel
  • No other concurrent chemotherapy

Endocrine therapy

  • No more than 1 prior hormonal therapy regimen for metastatic disease
  • At least 10 days since prior hormonal therapy
  • No concurrent hormonal therapy
  • No concurrent chronic corticosteroids

    • Concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or equivalent) allowed provided treatment was initiated > 6 months before study entry


  • Not specified


  • Not specified


  • More than 30 days since prior active treatment on another clinical trial
  • Concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia
  • No other concurrent anticancer therapy
  • No other concurrent investigational drugs

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 ClinicalTrials.gov identifier (NCT number): NCT00104624

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Institut Curie Hopital
Paris, France, 75248
Centre Henri Becquerel
Rouen, France, 76038
C.H. Senlis
Senlis, France, 60309
Institut Gustave Roussy
Villejuif, France, F-94805
Istituto Nazionale Di Riposo e Cura per Anziani
Rome, Italy, 00189
Clinique De Genolier
Genolier, Switzerland, Ch-1272
Sponsors and Collaborators
Study Chair: Suzette Delaloge Gustave Roussy, Cancer Campus, Grand Paris

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00104624     History of Changes
Other Study ID Numbers: CDR0000417747
First Posted: March 4, 2005    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013

Keywords provided by UNICANCER:
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