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Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy

Phase 2
65 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy


- Determine the objective response rate in elderly women with stage IV breast cancer
treated with oral vinorelbine.

- Determine the toxicity profile of this drug in these patients.

- Determine the time to progression in patients treated with this drug.

- Determine the quality of life of patients treated with this drug.

- Assess individual variation in responses (toxicity and/or activity), pharmacokinetic
parameters, and/or biologic correlates due to genetic differences in enzymes involved
in the transport, metabolism, and/or mechanism of action of this drug in these

OUTLINE: Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then after completion of the second course.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 7-18

Inclusion Criteria


- Histologically or cytologically confirmed stage IV breast cancer

- Eligible to receive first- or second-line chemotherapy

- At least 1 unidimensionally measurable lesion

- At least 20 mm in longest diameter

- Must be completely outside prior irradiation port unless there is proof of
progressive disease after completion of prior radiotherapy

- No untreated brain metastases

- Current metastatic CNS disease allowed only if previously treated and clinically
stable at study entry

- No meningeal carcinomatosis

- Hormone receptor status:

- Not specified



- 65 and over


- Female

Menopausal status:

- Not specified

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR

- Direct bilirubin normal if total bilirubin elevated or less than 2.5 times ULN
because of Gilbert's syndrome


- Creatinine no greater than 2 times ULN


- No grade 2 or greater peripheral neuropathy

- No other significant medical condition that would preclude study

- No active infection within the past 2 weeks

- No dysphagia or inability to swallow intact capsules


Biologic therapy:

- Not specified


- See Disease Characteristics

- No more than 1 prior chemotherapy regimen for metastatic disease

- No prior vinca alkaloids

- At least 4 weeks since other prior chemotherapy and recovered

Endocrine therapy:

- Prior hormonal therapy allowed

- No concurrent hormonal therapy


- See Disease Characteristics

- No prior radiotherapy to 25% or more of bone marrow

- At least 3 weeks since prior radiotherapy and recovered


- At least 3 weeks since prior major surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Edith A. Perez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

November 2001

Completion Date:

Related Keywords:

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



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
Altru Health Systems Grand Forks, North Dakota  58201
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Medcenter One Health System Bismarck, North Dakota  58501
CentraCare Health Plaza Saint Cloud, Minnesota  56303