NCT00066339

Brief Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

8 months

First QC Date

August 6, 2003

Last Update Submit

July 17, 2012

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

gefitinibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Radiological and/or clinical evidence of metastatic disease * Progressive disease after prior therapy with an antiestrogen (e.g., tamoxifen or faslodex) and a nonsteroidal aromatase inhibitor (e.g., anastrozole or letrozole) in the adjuvant and/or metastatic setting\* NOTE: \*Endocrine therapy must be the last treatment before study entry * Unidimensionally measurable disease * No rapidly progressive visceral metastases * No uncontrolled CNS metastases * Hormone receptor status: * Estrogen receptor and/or progesterone receptor positive PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Postmenopausal, defined as any of the following: * Natural menopause with at least 1 year since last menses * Radiation-induced oophorectomy with last menses more than 1 year ago * Chemotherapy-induced menopause with 1 year since last menses and serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels in the postmenopausal range * Surgical castration Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Transaminases no greater than 2.5 times ULN * No severe or uncontrolled hepatic disease Renal * No severe or uncontrolled renal disease Cardiovascular * No severe or uncontrolled cardiac disease Pulmonary * No severe or uncontrolled respiratory disease * No evidence of clinically active interstitial lung disease * Asymptomatic chronic stable radiographic changes allowed Other * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, contralateral breast cancer, or nonmelanoma skin cancer * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up * No other severe or uncontrolled systemic disease * No known hypersensitivity to any excipients of gefitinib * No unresolved chronic toxicity greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biologic agents Chemotherapy * No more than 1 prior chemotherapy regimen for metastatic breast cancer * No concurrent chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent hormonal therapy Radiotherapy * Prior radiotherapy allowed * No concurrent radiotherapy to any metastatic site Surgery * No surgery within 4 days after study drug administration Other * No prior epidermal growth factor receptor inhibitor therapy * More than 30 days since prior investigational drugs * No concurrent use of any of the following: * Phenytoin * Carbamazepine * Rifampin * Phenobarbital * Hypericum perforatum (St. John's Wort) * No concurrent systemic retinoids * No other concurrent investigational drugs or treatments * No other concurrent anticancer treatments * Concurrent bisphosphonates for the treatment and prevention of bony metastases are allowed provided therapy was initiated before study enrollment\* NOTE: \*Bisphosphonates may be initiated during study participation for the treatment of hypercalcemia only

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

Sponsors & Collaborators

Study Sites (1)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gefitinib

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

  • Martine J. Piccart-Gebhart, MD, PhD

    Jules Bordet Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

May 1, 2003

Primary Completion

January 1, 2004

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

BE(1)