NCT00052169

Brief Summary

The purpose of this study is to learn how breast cancer tumors respond to treatment combining the drugs docetaxel and ZD1839.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2003

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

December 18, 2007

Status Verified

December 1, 2007

First QC Date

January 24, 2003

Last Update Submit

December 13, 2007

Conditions

Breast Neoplasms

Keywords

metastatic breast cancerdocetaxelTaxotereZD 1839gefitinibNSABPadvanced breast cancerAstraZeneca

Outcome Measures

Primary Outcomes (2)

  • To estimate the clinical benefit rate of the combination of ZD 1839 and docetaxel; clinical benefit measured by clinical response, pathologic response, and stable disease (SD greater than or equal to 24 weeks)

    2 years

  • To characterize the safety profile of the combination of ZD 1839 and docetaxel as measured by the frequency and severity of adverse events.

    2 years

Secondary Outcomes (5)

  • To estimate the duration of clinical benefit.

    2 years

  • To estimate the objective tumor response rate (using RECIST best overall response of CR + PR).

    2 years

  • To estimate the duration of tumor response.

    2 years

  • To estimate progression-free survival.

    2 years

  • To estimate time to treatment failure by measuring time to treatment failure (includes disease progression, second primary cancer, death from any cause, or discontinuation of protocol therapy in the absence of disease progression).

    2 years

Interventions

ZD1839 in combination with docetaxelDRUG

Docetaxel given as 75 mg/m2 IV every 3 weeks combined with ZD1839 (IRESSA) 250 mg orally daily until disease progression or withdrawal criteria are met.

Also known as: Docetaxel (Taxotere), ZD1839, gefitinib (Iressa)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic confirmation of breast cancer
  • Signed consent
  • Current diagnosis of metastatic breast cancer
  • At least one uni-dimensionally measurable lesion with clearly defined margins
  • Patients taking bisphosphonates for documented prior bone metastasis may be included
  • Patients may have received prior adjuvant chemotherapy including an anthracycline and/or an alkylating agent. Patients may have received prior paclitaxel or trastuzumab for adjuvant therapy. Patients may not have received prior docetaxel treatment
  • Patients may have received unlimited prior hormonal therapy regimens for metastatic disease or adjuvant therapy and must have documentation of progressive disease prior to entry. Hormonal therapy must be discontinued at least 2 weeks prior to study entry
  • Patients may have received prior radiation therapy provided it was completed at least 2 weeks before study entry. Prior radiotherapy to treat bone metastasis or spinal cord compression is permitted provided it was completed prior to study entry
  • Zubrod performance status 0, 1, or 2
  • Life expectancy of 12 weeks or more in opinion of investigator
  • LVEF greater than or equal to LLN without clinical signs or symptoms of heart failure
  • adequate bone marrow, hepatic, and renal function
  • Ineligibility Criteria
  • Prior ZD1839 or other anti EGFR or small molecule TKI
  • Previous or concurrent chemo or Herceptin for metastatic breast cancer
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NSABP Operations Center

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (1)

  • Dennison SK, Jacobs SA, Wilson JW, Seeger J, Cescon TP, Raymond JM, Geyer CE, Wolmark N, Swain SM. A phase II clinical trial of ZD1839 (Iressa) in combination with docetaxel as first-line treatment in patients with advanced breast cancer. Invest New Drugs. 2007 Dec;25(6):545-51. doi: 10.1007/s10637-007-9055-6. Epub 2007 Jun 12.

    PMID: 17563856RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

GefitinibDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Norman Wolmark, MD

    NSABP Foundation Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

January 1, 2003

Study Completion

September 1, 2006

Last Updated

December 18, 2007

Record last verified: 2007-12

Locations

US(1)