Know Cancer

forgot password

A Multi-Institutional Phase II Pilot Trial With Weekly Docetaxel and Herceptin as First or Second Line Therapy for HER2/Neu Overexpressing Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Multi-Institutional Phase II Pilot Trial With Weekly Docetaxel and Herceptin as First or Second Line Therapy for HER2/Neu Overexpressing Metastatic Breast Cancer

OBJECTIVES: I. Determine the objective response rate of women with HER2-neu overexpressing
recurrent or metastatic breast cancer treated with trastuzumab (Herceptin) in combination
with docetaxel. II. Determine the toxicity of this treatment regimen in these patients. III.
Determine the duration of response to this treatment regimen in these patients. IV.
Determine the time to progression in these patients after receiving this treatment regimen.
V. Compare HER2-neu overexpression as determined by fluorescent in situ hybridization (FISH)
versus immunohistochemistry, and correlate these findings with response to this treatment
regimen in these patients. VI. Correlate HER2-neu activation by immunohistochemistry and the
extracellular domain of HER2-neu by ELISA with response to this treatment regimen in these

OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 30 minutes weekly
for 6 weeks plus trastuzumab (Herceptin) IV over 30-90 minutes weekly for 8 weeks. Treatment
continues every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months, every 3 months for 9 months, and then every 6
months thereafter.

PROJECTED ACCRUAL: A total of 18-34 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic breast cancer
HER2-neu overexpressing tumor (2+ or 3+) Measurable or evaluable disease If bone disease
only, must have lytic lesions No carcinomatous meningitis or untreated or uncontrolled
brain parenchymal disease Prior brain parenchymal disease allowed if controlled by
appropriate therapy given at least 8 weeks prior to study, and patient is asymptomatic
from CNS disease Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least
3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin normal Alkaline phosphatase no greater than 2.5 times upper limit of
normal (ULN) SGOT and SGPT no greater than 1.5 times ULN Renal: Creatinine no greater than
2.0 mg/dL Cardiovascular: No congestive heart failure Ejection fraction greater than 45%
by MUGA No myocardial infarction within the past 6 months No ischemic heart disease
requiring medication No uncontrolled hypertension Other: No peripheral neuropathy grade 2
or more No other prior malignancy within the past 5 years except curatively treated basal
cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or
contralateral breast cancer No active unresolved infection No history of hypersensitivity
reaction to products containing Polysorbate 80 No poorly controlled diabetes mellitus Not
pregnant Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifiers
Chemotherapy: Prior adjuvant chemotherapy allowed No more than 1 prior chemotherapy
regimen for metastatic disease No prior taxane (docetaxel or paclitaxel) Prior doxorubicin
allowed if total dose less than 250 mg/m2 No other concurrent chemotherapy Endocrine
therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: At
least 4 weeks since prior radiotherapy No prior cumulative radiotherapy to more than 25%
of bone marrow No concurrent radiotherapy Surgery: Not specified Other: At least 7 days
since prior antibiotics No other concurrent investigational drugs No other concurrent
antineoplastic therapy No concurrent parenteral antibiotics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Ingrid Mayer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

July 2003

Related Keywords:

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



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Evanston Hospital Evanston, Illinois  60201-1781
Providence Hospital Mobile, Alabama  36608
Owensboro Medical Health System Owensboro, Kentucky  42303
Memorial Health Care System Chattanooga, Tennessee  37404
Erlanger Health Systems Chattanooga, Tennessee  37403
Williamson Medical Center Franklin, Tennessee  37067
Jackson-Madison County Hospital Jackson, Tennessee  38301
Tennessee Cancer Specialists Knoxville, Tennessee  37920
Methodist/Thompson Oncology Research Knoxville, Tennessee  37916
Boston Baskin Cancer Group Memphis, Tennessee  38104
St. Thomas Health Services Nashville, Tennessee  37205
Methodist Medical Center of Oak Ridge Oak Ridge, Tennessee  37831