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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030537 |
Purpose
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: erlotinib hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Pilot Study to Evaluate Epidermal Growth Factor Receptor Signaling After Treatment With Oral OSI-774 in Patients With Locally Advanced or Metastatic Breast Cancer |
| Study Start Date: | November 2001 |
OBJECTIVES:
OUTLINE: Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed within 4 weeks.
PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 7-10 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
No symptomatic or untreated brain metastases or carcinomatous meningitis
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Ophthalmic:
No prior abnormalities of the cornea, including:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |
| Center for Cancer Research | |
| Bethesda, Maryland, United States, 20889-5101 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Antoinette R. Tan, MD | National Cancer Institute (NCI) |
More Information
| ClinicalTrials.gov Identifier: | NCT00030537 History of Changes |
| Obsolete Identifiers: | NCT00027313 |
| Other Study ID Numbers: | CDR0000069175, NCI-02-C-0061, NCI-5403 |
| Study First Received: | February 14, 2002 |
| Last Updated: | December 13, 2008 |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer stage IIIB breast cancer male breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |