Clinical trial · Interventional
Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer
Phase I/II Trial of ZD1839 (Iressa®), Trastuzumab (Herceptin®), and Docetaxel (Taxotere®) in Patients With erbB-2 (HER-2) Overexpressing, Stage IV Breast Carcinoma
NCT00086957CI-TRIAL-00026158completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. 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, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and trastuzumab with docetaxel may kill more tumor cells. PURPOSE: This phase I/II trial is studying the best dose of docetaxel when given together with gefitinib and trastuzumab in treating patients with metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| gefitinib | Drug | Gefitinib | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZD1839, Trastuzumab and Docetaxel
- interventionNames
- Biological: trastuzumab
- Drug: docetaxel
- Drug: gefitinib
Primary outcomes (2)
- measure
- Number of Participants With at Least One Dose Limiting Toxicity in Phase I
- timeFrame
- 4 weeks from start of treatment, up to 2 years
- description
- Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater except for hematological toxicities which must be grade 4. Interstitial Lung Disease (ILD) related to treatment should be considered as a DLT regardless of the grade.
- measure
- Recommended Phase II Dose
- timeFrame
- 4 weeks from start of treatment, up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTSomlo G, Koczywas M, Luu T, et al.: A phase I-II study of trastuzumab, gefitinib, and docetaxel as first line chemotherapy in patients with HER-2 overexpressing stage IV breast carcinoma. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-2035, 2005.