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A Randomized, Phase II Trial of Weekly Taxol (Paclitaxel) Versus Weekly Taxol Plus Paraplatin (Carboplatin) as First-Line Chemotherapy in Patients Age 65 Years or Older With Metastatic Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

A Randomized, Phase II Trial of Weekly Taxol (Paclitaxel) Versus Weekly Taxol Plus Paraplatin (Carboplatin) as First-Line Chemotherapy in Patients Age 65 Years or Older With Metastatic Breast Cancer


- Compare the objective response rate in women treated with paclitaxel with or without
carboplatin as first-line chemotherapy for metastatic breast cancer.

- Compare the overall survival, time to disease progression, and duration of response in
these patients treated with these regimens.

- Compare the safety of these regimens in this patient population.

- Compare the quality of life of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
adjuvant chemotherapy (yes vs no) and ECOG performance status (0-1 vs 2). Patients are
randomized to one of two treatment arms.

- Arm I: Patients receive paclitaxel IV over 1 hour weekly for 3 weeks.

- Arm II:Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes
weekly for 3 weeks.

Treatment in both arms continues every 4 weeks in the absence of disease progression or
unacceptable toxicity.

Quality of life is assessed at baseline, before each course during study, and then after
completion of study.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed breast cancer

- Must have clinical evidence of stage IV (M1) disease

- HER-2/neu negative (0, 1+, or 2+ by immunohistochemistry or fluorescent in situ
hybridization) OR status unknown

- At least 1 measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Patients with bone-only disease are not eligible

- Ineligible if currently experiencing a complete or partial response to prior hormonal

- Patients with disease progression after prior response to hormonal therapy are

- Disease progression without prior hormonal therapy is allowed

- Stable or asymptomatic brain metastasis allowed if:

- Other measurable disease exists

- Cranial irradiation completed and brain metastasis stable for at least 4 weeks
before study

- Hormone receptor status:

- Not specified



- 18 and over


- Female

Menopausal status:

- Pre- or post-menopausal

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months


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

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


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 2 times ULN


- Creatinine no greater than 2 times ULN

- Corrected calcium less than 12 mg/dL


- No New York Heart Association class III or IV heart disease

- No documented myocardial infarction within the past 6 months

- No congestive heart failure

- No unstable angina

- No clinically significant pericardial effusion or arrhythmia


- No active serious infection

- No prior significant allergic reactions to drugs containing Cremophor, such as
teniposide, cyclosporine, or vitamin K

- No clinically significant (greater than grade 1) peripheral neuropathy

- No other serious underlying medical condition that would preclude study participation


Biologic therapy:

- More than 6 months since prior adjuvant bone marrow or peripheral blood stem cell

- More than 6 months since prior adjuvant monoclonal antibody therapy

- More than 6 months since prior adjuvant vaccine therapy

- No prior trastuzumab (Herceptin)

- No concurrent anticancer immunotherapy


- No prior chemotherapy for metastatic breast cancer

- More than 6 months since prior adjuvant high-dose chemotherapy

- More than 6 months since prior adjuvant taxanes or any other adjuvant chemotherapy

- Prior adjuvant taxanes allowed only if administered every 3 weeks

Endocrine therapy:

- See Disease Characteristics

- Any number of prior hormonal therapies for metastatic breast cancer allowed

- Patients with definite signs of progression may begin study therapy immediately
after stopping hormonal therapy

- No concurrent anticancer hormonal agents (including megestrol)


- At least 3 weeks since prior radiotherapy (4 weeks for cranial irradiation)

- No prior radiotherapy to 30% or more of bone marrow

- No concurrent radiotherapy except for palliation of painful bone metastasis or
pathologic fractures to the area of known lytic disease


- At least 3 weeks since prior major surgery


- More than 6 months since prior neoadjuvant therapy

- No other concurrent anticancer drugs

Type of Study:


Study Design:

Allocation: Randomized, 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:

January 2001

Completion Date:

Related Keywords:

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



St. Barnabas Medical Center Livingston, New Jersey  07039
University of California Davis Cancer Center Sacramento, California  95817
New Britain General Hospital New Britain, Connecticut  06050
Scott and White Clinic Temple, Texas  76508
Mayo Clinic Jacksonville, Florida  32224
Wilshire Oncology Medical Group, Inc. Rancho Cucamonga, California  91730
Oncology Consultants Houston, Texas  77024
Maine Center for Cancer Medicine and Blood Disorders Scarborough, Maine  04074
Scranton Hematology-Oncology Scranton, Pennsylvania  18510
Dean Medical Center Madison, Wisconsin  53715
Seattle Cancer Care Alliance Seattle, Washington  98109
St. John's Mercy Medical Center Saint Louis, Missouri  63141
Highlands Oncology Group Springdale, Arkansas  72764
Texas Cancer Care Fort Worth, Texas  76104
Cancer Research Network, Inc. Plantation, Florida  33324
Northern Virginia Oncology Group, P.C. Fairfax, Virginia  22031
West Clinic Memphis, Tennessee  38117
Monterey Bay Oncology Monterey, California  93940
Center for Hematology and Oncology Boca Raton, Florida  33486
MacNeal Cancer Center Berwyn, Illinois  60402
Oncology Specialists, SC Park Ridge, Illinois  60068
Maryland Hematology/Oncology Associates Baltimore, Maryland  21236
Finger Lakes Community Cancer Center Clifton Springs, New York  14432
Clinical Hematology & Oncology Service, Inc. Akron, Ohio  44302
East Tennessee Oncology/Hematology, P.C. Knoxville, Tennessee  37920