Docetaxel in Treating Older Women With Metastatic Breast Cancer

This study has been terminated.
(Toxicity issues)
Information provided by (Responsible Party):
UNICANCER Identifier:
First received: March 3, 2005
Last updated: September 2, 2013
Last verified: September 2013

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 Intervention Phase
Breast Cancer
Drug: docetaxel
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:

Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Mood status as measured by the Geriatric Depression Scale [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 53
Study Start Date: May 2005
Study Completion Date: July 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   70 Years and older
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: UNICANCER Identifier: NCT00104624     History of Changes
Other Study ID Numbers: CDR0000417747, FRE-FNCLCC-GERICO-04/0406, EU-20504
Study First Received: March 3, 2005
Last Updated: September 2, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UNICANCER:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on November 30, 2015