A Phase II Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of Herceptin Administered Subcutaneously in Combination With Paclitaxel in Women With HER2 Overexpressing Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase II Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of Herceptin Administered Subcutaneously in Combination With Paclitaxel in Women With HER2 Overexpressing Metastatic Breast Cancer


OBJECTIVES: I. Evaluate the safety and tolerability of subcutaneous trastuzumab (Herceptin)
plus paclitaxel in women with HER2 overexpressing metastatic breast cancer. II. Assess the
activity of this treatment regimen in these patients. III. Determine the pharmacokinetics of
trastuzumab and paclitaxel in this regimen.

OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one
of two treatment arms. Patients receive a loading dose of trastuzumab (Herceptin) IV over 90
minutes followed by paclitaxel IV over 3 hours on day 0. Paclitaxel is repeated every 3
weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Arm I:
Patients receive trastuzumab subcutaneously (SC) weekly starting day 7. Arm II: Patients
receive trastuzumab SC twice weekly starting day 7. Treatment with trastuzumab SC continues
for 48 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS: HER2 overexpressing (3+) metastatic breast cancer by
immunohistochemistry, or amplified by fluorescent in situ hybridization (FISH) No prior
chemotherapy for breast cancer metastases No bilateral disease Bidimensionally measurable
disease At least 1 target lesion greater than 1 cm2 No significant lymphedema in the arm
ipsilateral to mastectomy site, unless patient has an indwelling catheter for the purpose
of chemotherapy infusion No CNS metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic:
Hemoglobin at least 9.0 g/dL WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper
limit of normal (ULN) ALT, AST, and alkaline phosphatase no greater than 2.5 times ULN (no
greater than 4.0 times ULN with liver or bone metastases) Renal: Creatinine no greater
than 1.5 times ULN Cardiovascular: No clinically significant cardiovascular disease (e.g.,
uncontrolled hypertension, myocardial infarction, unstable angina, intractable arrhythmia,
congestive heart failure, or New York Heart Association class II-IV heart disease) Left
ventricular ejection fraction at least 50% or above lower limit of normal, whichever is
lower Other: No severe hypersensitivity to products containing Cremophor EL (e.g.,
cyclosporine or teniposide for injection concentrate) No other serious medical condition
that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 14 days since prior immunotherapy No
prior trastuzumab (Herceptin) No other concurrent immunotherapy Chemotherapy: See Disease
Characteristics Prior cytotoxic chemotherapy allowed in adjuvant setting Prior cumulative
doxorubicin exposure no greater than 300 mg/m2 At least 1 year since prior taxane therapy
No other concurrent chemotherapy Endocrine therapy: At least 14 days since prior hormonal
therapy No concurrent hormonal therapy (e.g., tamoxifen, megestrol acetate,
fluoxymesterone, or aminoglutethimide) Radiotherapy: At least 14 days since prior
radiotherapy No concurrent radiotherapy to target lesions Surgery: Not specified Other: At
least 30 days since other prior investigational agent or procedure No other concurrent
investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Andrew D. Seidman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067790

NCT ID:

NCT00005635

Start Date:

January 2000

Completion Date:

Related Keywords:

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

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021