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Treatment of Refractory Stage IV Metastatic Breast Cancer With Weekly Paclitaxel or Weekly Paclitaxel and Herceptin Following Autologous/Syngeneic Stem Cell Transplant


Phase 2
N/A
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

Treatment of Refractory Stage IV Metastatic Breast Cancer With Weekly Paclitaxel or Weekly Paclitaxel and Herceptin Following Autologous/Syngeneic Stem Cell Transplant


OBJECTIVES: I. Determine the toxicity of paclitaxel with or without trastuzumab following
high dose chemotherapy with autologous or syngeneic peripheral blood stem cell
transplantation in patients with stage IV breast cancer. II. Assess the overall survival of
these patients.

OUTLINE: Patients begin study treatment within 50-150 days after autologous or syngeneic
peripheral blood stem cell transplantation. Patients are stratified according to
overexpression of HER2-Neu (yes vs no), which determines the type of therapy. Arm I
(overexpression of HER2-Neu): Patients receive paclitaxel IV over 60 minutes followed by the
initial loading dose of trastuzumab IV over 90 minutes. If the loading dose is tolerated
well, then patients receive maintenance trastuzumab IV over 30 minutes. Treatment with
paclitaxel followed by maintenance trastuzumab repeats once every week for 12 weeks in the
absence of disease progression or unacceptable toxicity. Arm II (no overexpression of
Her2-Neu): Patients receive paclitaxel IV over 60 minutes once every week for 12 weeks.
Patients with hormone receptor positive disease also receive antihormonal therapy (tamoxifen
or anastrozole) as clinically indicated. Patients with isolated metastasis such as a single
bone lesion may receive radiotherapy to that site after completion of study treatment.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study over
2-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Refractory stage IV breast cancer Received high dose chemotherapy
(HDC) with autologous or syngeneic peripheral blood stem cell transplantation (PBSCT) OR
Stage IV breast cancer Failed to achieve complete response to HDC with autologous or
syngeneic PBSCT at initial restaging following HDC No enrollment on protocol FHCRC-976,
unless evidence of no response or progressive disease at initial restaging following
transplantation Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Performance
status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Platelet count at
least 50,000/mm3 (untransfused) Absolute neutrophil count greater than 1,000/mm3 (without
filgrastim (G-CSF) support) Hepatic: Bilirubin no greater than 2.5 times upper limit of
normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0
mg/dL Cardiovascular: LVEF greater than 40% No poorly controlled arrhythmias No prior
coronary artery disease No congestive heart failure within last year No myocardial
infarction within past 2 years Other: No active infection No grade 3 regimen related
toxicity according to Bearman model No allergy to paclitaxel, trastuzumab, or benzyl
alcohol No grade 3 peripheral neuropathy with last chemotherapy HIV negative Not pregnant
or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics Endocrine therapy: Concurrent antihormonal therapy (tamoxifen or
anastrozole) allowed as clinically indicated for hormone receptor positive disease
Radiotherapy: Not specified Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Leona A. Holmberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1338.00

NCT ID:

NCT00004013

Start Date:

January 1999

Completion Date:

October 2001

Related Keywords:

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109