Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2

August 16, 2013 updated by: Genentech, Inc.

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

RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of two different regimens of trastuzumab plus paclitaxel in treating women who have metastatic breast cancer that overexpresses HER2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (ACTUAL)

November 1, 2001

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

March 15, 2004

First Posted (ESTIMATE)

March 16, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067790
  • MSKCC-99118
  • GENENTECH-H1994g
  • NCI-G00-1769

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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