Clinical trial · Interventional
Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast
EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast
NCT00082667CI-TRIAL-00009550terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left VICC
Summary
Brief summary (as posted)
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether surgery is more effective with or without gefitinib in treating ductal carcinoma in situ. PURPOSE: This randomized phase II trial is studying how well gefitinib together with surgery works compared to surgery alone for the treatment of women with ductal carcinoma in situ of the breast.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by surgery.
- timeFrame
- at time of surgery, after 7-14 days of gefitinib
Secondary outcomes (2)
- measure
- Compare the effect of gefitinib vs. placebo, followed by surgery on cell turnover in vivo in EGFR-positive vs. EGFR-negative patients
- timeFrame
- at time of surgery, after 7-14 days of gefitinib
- measure
- Compare the effects of gefitinib in ER-positive vs. ER-negative DCIS and in HER2-positive vs. HER2-negative DCIS
- timeFrame
- at time of surgery, after 7-14 days of gefitinib
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR mammogram highly suspicious for DCIS * No invasive disease * Not completely excised * Epidermal growth factor receptor (EGFR) positive (\> 10% of cells stained) * Planned lumpectomy or mastectomy within the next 2-4 weeks * Hormone receptor status: * Estrogen receptor status known PATIENT CHARACTERISTICS: Age * 35 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Granulocyte count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin \< 1.5 mg/dL * SGOT ≤ 2 times upper limit of normal (ULN) * SGPT \< 1.5 times ULN * PT and PTT ≤ 1.5 times ULN * INR ≤ 1.5 times ULN Renal * Creatinine \< 1.5 mg/dL Cardiovascular * No New York Heart Association class I-IV heart disease Pulmonary * No acute asthma Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Random blood sugar \< 2.5 times ULN * No known hypersensitivity to study drug or its excipients * No nonhealing wound or fracture * No active infection * No other malignancy within the past 5 years except basal cell carcinoma, breast carcinoma, or carcinoma in situ of the cervix * No psychosis or severe depression * No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * No prior trastuzumab (Herceptin®) Chemotherapy * At least 1 year since prior chemotherapy * No concurrent chemotherapy Endocrine therapy * At least 1 year since prior aromatase inhibitors * At least 1 year since prior antiestrogens or luteinizing hormone-releasing hormone agonists or antagonists * No concurrent glucocorticoids * Concurrent oral contraceptives allowed * Concurrent hormone replacement therapy allowed Radiotherapy * At least 1 year since prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics * Recovered from prior oncologic or other major surgery * No prior organ allograft Other * Recovered from all prior therapy (except alopecia) * More than 30 days since prior non-approved or investigational drugs * No prior definitive local therapy * No prior immunosuppressive therapy * No prior gefitinib * No other prior EGFR inhibitors * No other concurrent cytotoxic drugs * No concurrent warfarin for anticoagulation * No concurrent CYP3A4 inducers, including any of the following: * Phenytoin * Carbamazepine * Barbiturates * Rifampin * Phenobarbital * Hypericum perforatum (St. John's wort) * Ethosuximide * Griseofulvin * Nafcillin * Nelfinavir * Nevirapine * Oxcarbazepine * Phenylbutazone * Primidone * Rifabutin * Rofecoxib * Sulfamethazine * Sulfinpyrazone * Troglitazone * No concurrent antiretroviral treatment for HIV-positive patients
References
Publications (0)
Data not yet available
No reference posted for this study.