Completed

Phase I/II Trial of ZD1839 (Iressa®), Trastuzumab (Herceptin®), and Docetaxel (Taxotere®) in Patients With erbB-2 (HER-2) Overexpressing, Stage IV Breast Carcinoma

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What is being tested

trastuzumab

+ docetaxel

+ gefitinib

BiologicalDrug
Who is being recruted

Breast Diseases+2

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorCity of Hope Medical Center
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the safety and efficacy of gefitinib, trastuzumab (Herceptin®), and docetaxel, in terms of time to disease progression, in patients with HER2/neu-overexpressing metastatic adenocarcinoma of the breast. Secondary * Determine the objective tumor response rate in patients treated with this regimen. * Correlate expression and/or degree of phosphorylation of epidermal growth factor receptor, HER2/neu, c-fos, Akt, ERK½, P13K, p53, p21, and p27 with outcome in patients treated with this regimen. OUTLINE: This is a phase I, multicenter, dose-escalation study of docetaxel followed by a phase II study. Patients are stratified according to trastuzumab (Herceptin®)-naive vs trastuzumab-failure. * Phase I: Patients receive oral gefitinib once daily on days 2-14. Patients also receive trastuzumab\* IV over 30-90 minutes and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: \*Trastuzumab is given at a higher dose (loading dose) in course 1 and then at a lower dose in subsequent courses. Cohorts of 3-6 patients receive docetaxel at dose level 1. If no dose-limiting toxicity (DLT) is observed in the first cohort of 3 patients, the dose of docetaxel remains the same. If 1 DLT is observed in the first cohort of 3 patients, 3 additional patients are added (for a total of 6 patients) to dose level 1. If no further DLTs are observed at dose level 1, the dose of docetaxel remains the same. If 2 of 3 or 2 of 6 patients experience DLT at dose level 1, the dose of docetaxel is considered above the maximum tolerated dose (MTD) and is subsequently reduced. If 2 of 3 or 2 of 6 patients experience DLT at the reduced dose of docetaxel, the study is stopped. * Phase II: Patients receive docetaxel at the MTD and gefitinib and trastuzumab as in phase I. Patients are followed for survival. PROJECTED ACCRUAL: A total of 3-76 patients will be accrued for this study within 26 months.

Official TitlePhase I/II Trial of ZD1839 (Iressa®), Trastuzumab (Herceptin®), and Docetaxel (Taxotere®) in Patients With erbB-2 (HER-2) Overexpressing, Stage IV Breast Carcinoma 
NCT00086957
Principal SponsorCity of Hope Medical Center
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin Diseases

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Metastatic disease * HER-2/neu overexpression (3+ by immunohistochemistry OR 2+ by fluorescence in situ hybridization) * Measurable or evaluable disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * AST and ALT \< 2.5 times upper limit of normal (ULN) (5.0 times ULN in the presence of liver metastases) * Bilirubin \< 1.5 times ULN * No unstable or uncompensated hepatic disease Renal * Creatinine \< 1.6 mg/dL * No unstable or uncompensated renal disease Cardiovascular * LVEF \> 45% by echocardiogram or MUGA * No prior New York Heart Association class I-IV heart disease * No prolonged PR interval or atrioventricular block on ECG * No unstable or uncompensated cardiac disease Pulmonary * No unstable or uncompensated respiratory disease * No clinically active interstitial lung disease * Patients who are asymptomatic and have chronic stable radiographic changes are allowed Immunologic * No autoimmune disorders * No conditions of immunosuppression * No severe hypersensitivity to taxane or gefitinib or any of its excipients Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other prior or concurrent malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix * No other severe or uncontrolled systemic disease * No other acute or chronic medical condition that would preclude study participation * No other significant clinical disorder or laboratory finding that would preclude study participation * No psychiatric illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Prior adjuvant trastuzumab (Herceptin®) allowed if \> 6 months elapsed before disease recurrence * No prior trastuzumab for metastatic breast cancer * No prior monoclonal antibodies directed at the epidermal growth factor receptor (EGFR) Chemotherapy * Prior adjuvant chemotherapy (or as first-line therapy for metastatic breast cancer) allowed * Prior adjuvant taxane allowed if completed \> 6 months before diagnosis of metastatic breast cancer * No prior docetaxel for metastatic breast cancer Endocrine therapy * Prior adjuvant hormonal therapy (or as first-line therapy for metastatic breast cancer) allowed * No concurrent hormonal therapy * Concurrent steroids allowed provided dose is stable Radiotherapy * Not specified Surgery * Fully recovered from prior oncologic or other major surgery * No concurrent surgery within 7 days of gefitinib administration Other * Recovered from prior anticancer therapy (alopecia allowed) * More than 30 days since prior non-approved drug or investigational agent * No other prior EGFR-directed therapy (i.e., tyrosine kinase inhibitors) * No concurrent use of any of the following medications: * Phenytoin * Carbamazepine * Barbiturates * Rifampin * Hypericum perforatum (St. John's wort) * No other concurrent anticancer therapy * No concurrent cardioprotective drugs * No concurrent oral retinoids * Concurrent participation in the City of Hope indium-labeled trastuzumab imaging study allowed

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

Tower Cancer Research Foundation

Beverly Hills, United StatesSee the location
Suspended

City of Hope Comprehensive Cancer Center

Duarte, United States
Suspended

Hematology Oncology Consultants-Hemet

Hemet, United States
Suspended

Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center

Long Beach, United States
Completed6 Study Centers