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Management of Metastatic Breast Cancer in Frail Patients

Phase 2
65 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Management of Metastatic Breast Cancer in Frail Patients

OBJECTIVES: I. Determine the safety and efficacy of gemcitabine in the treatment of elderly
women with metastatic breast cancer. II. Evaluate the quality of life in these patients.

OUTLINE: Patients receive gemcitabine IV over 1 hour weekly for 7 consecutive weeks in an 8
week course. Treatment then continues weekly for 3 consecutive weeks in 4 week courses in
the absence of disease progression or unacceptable toxicity. Quality of life is assessed
prior to treatment and then every 12 weeks. Patients are followed every 3 months for 2
years, then every 6 months until year 5, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Metastatic breast cancer Measurable disease No progression after
3 or more different forms of chemotherapy Hormone receptor positive breast cancer must be
refractory to at least two forms of hormonal treatment (including antiestrogen, aromatase
inhibitor, and/or progestin) unless there is life threatening metastases (e.g.,
lymphangitic metastases to the lung or liver metastases) Must meet at least one of the
following characteristics for frailty: ECOG 2-4 Dependence in at least one activity of
daily living 85 and over History of three or more falls in the past 6 months Mild dementia
(must be oriented in time, space, and location) Three or more comorbid conditions Hormone
receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 65 and over Sex: Female Menopausal status: Not specified
Performance status: See Disease Characteristics Life expectancy: Greater than 12 weeks
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Neutropenia or thrombocytopenia secondary to myelophthisis from breast cancer
allowed Hepatic: Increased bilirubin allowed Renal: Renal insufficiency allowed
Cardiovascular: Congestive heart failure allowed Other: No known allergy to gemcitabine

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4
weeks since prior radiotherapy to bony areas or CNS metastases Surgery: Not specified
Other: Concurrent bisphosphonates allowed No concurrent participation in other
investigational studies

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (ORR)

Outcome Description:

Investigators planned to determine efficacy (objective response rate [ORR] by Response Evaluation Criteria In Solid Tumors [RECIST]).

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lodovico Balducci, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Federal Government

Study ID:




Start Date:

August 1999

Completion Date:

June 2000

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms