NCT00030537

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2001

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

June 19, 2013

Status Verified

October 1, 2002

First QC Date

February 14, 2002

Last Update Submit

June 17, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancerstage IIIB breast cancermale breast cancer

Interventions

erlotinib hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Locally advanced or metastatic disease * Incurable disease * Tumor accessible for biopsy * Prior breast cancer allowed * No symptomatic or untreated brain metastases or carcinomatous meningitis * Neurologically stable patients with inactive brain metastases are allowed if off corticosteroids for at least 4 weeks prior to study * 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: * At least 3 months Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * ALT/AST no greater than 2.5 times upper limit of normal Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * LVEF at least 40% * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Ophthalmic: * No prior abnormalities of the cornea, including: * Dry eye syndrome or Sjogren's syndrome * Congenital abnormality (e.g., Fuch's dystrophy) * Abnormal slit-lamp examination with a vital dye (e.g., fluorescein or Bengal-Rose) * Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) * No concurrent use of contact lenses Other: * No prior allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib (e.g., gefitinib or other anilinoquinazolines) * No other concurrent uncontrolled illness * No active infection * No uncontrolled diabetes mellitus * No psychiatric illness or social situation that would preclude study * No untreated life-threatening disease * No other primary malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer * Weight less than 136 kg * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * At least 2 weeks since prior hormonal therapy * No concurrent hormonal therapy Radiotherapy: * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy except localized external beam radiotherapy for palliative treatment of metastatic disease (cannot include significant cardiac muscle within the radiotherapy field) Surgery: * Not specified Other: * No other concurrent investigational anticancer agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Center for Cancer Research

Bethesda, Maryland, 20889-5101, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

  • Tan AR, Yang X, Hewitt SM, Berman A, Lepper ER, Sparreboom A, Parr AL, Figg WD, Chow C, Steinberg SM, Bacharach SL, Whatley M, Carrasquillo JA, Brahim JS, Ettenberg SA, Lipkowitz S, Swain SM. Evaluation of biologic end points and pharmacokinetics in patients with metastatic breast cancer after treatment with erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor. J Clin Oncol. 2004 Aug 1;22(15):3080-90. doi: 10.1200/JCO.2004.08.189.

    PMID: 15284258RESULT

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Antoinette R. Tan, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

November 1, 2001

Study Completion

March 1, 2003

Last Updated

June 19, 2013

Record last verified: 2002-10

Locations

US(2)