Clinical trial · Interventional
Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
ZD1839 (IRESSA) In Tamoxifen-Resistant Metastatic Breast Cancer
NCT00080743CI-TRIAL-00002521completedPhase 2ClinicalTrials.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. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Combining gefitinib with tamoxifen may be effective in killing tumor cells that have become resistant (stopped responding) to tamoxifen. PURPOSE: This randomized phase II trial is studying how well giving gefitinib together with tamoxifen works compared to gefitinib alone in treating patients with metastatic breast cancer that has stopped responding to tamoxifen.
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)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Tamoxifen
- description
- Tamoxifen 20 mg po once daily
- interventionNames
- Drug: gefitinib
- Drug: tamoxifen citrate
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo comparator one tablet po once daily
- interventionNames
- Drug: gefitinib
- Drug: Placebo
Primary outcomes (1)
- measure
- Clinical benefit rate (complete response, partial response, and stable disease) for 26 weeks
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Metastatic disease * Initial clinical benefit from tamoxifen for metastatic disease, defined by 1 of the following: * Stable disease for 24 weeks or longer * Objective tumor response * Documentation of clinical progression on tamoxifen within the past 6 weeks * Hormone receptor status: * Estrogen or progesterone receptor positive on most recently analyzed biopsy PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * AST ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance ≥ 50 mL/min Pulmonary * No clinically active interstitial lung disease * Patients with asymptomatic chronic stable radiographic changes are eligible Other * Not pregnant or nursing * Fertile patients must use effective contraception * No known hypersensitivity to gefitinib * No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent trastuzumab (Herceptin®) Chemotherapy * No concurrent cytotoxic chemotherapy Endocrine therapy * See Disease Characteristics * At least 2 weeks since other prior tamoxifen * No concurrent hormone replacement therapy * No other concurrent antiestrogens, including raloxifene * No concurrent aromatase inhibitors * No concurrent megestrol * Concurrent systemic steroids for reasons other than skin toxicity allowed provided the steroids were initiated before study entry AND dose remains stable Radiotherapy * Concurrent palliative radiotherapy as short-term treatment for symptomatic bone metastases allowed provided other evaluable sites of disease are present AND treatment lasts no more than 14 days Surgery * Recovered from prior oncologic or other major surgery * No concurrent surgery during and for 7 days after study treatment * No concurrent ophthalmic surgery Other * Recovered from all prior therapy (except alopecia) * More than 30 days since prior investigational drugs * No other concurrent investigational agents * No concurrent administration of any of the following: * Phenytoin * Carbamazepine * Barbiturates * Rifampin * Phenobarbital * Hypericum perforatum (St. John's wort) * Systemic retinoids * CYP3A4 inhibitors (e.g., itraconazole) * Drugs that cause significant sustained elevation in gastric pH ≥ 5
References
Publications (0)
Data not yet available
No reference posted for this study.