Anastrozole & ZD1839 Compared With Fulvestrant & ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.

Study NCT00057941 Information provided by Eastern Cooperative Oncology Group

First Received on April 7, 2003. Last Updated on April 11, 2011 History of Changes

Results First Received: April 11, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Breast Cancer
Interventions:	Drug: anastrozole Drug: fulvestrant Drug: gefitinib

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened on September 16, 2003 and closed on May 29, 2007, with final accrual of 148 patients, 74 on each arm. Patients were accrued through ECOG group.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Arm I (Anastrozole and ZD1839)	Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
Arm II (Fulvestrant and ZD1839)	Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.

Participant Flow: Overall Study

	Arm I (Anastrozole and ZD1839)	Arm II (Fulvestrant and ZD1839)
STARTED	74	74
Treated	74	74
Eligible	72	69
COMPLETED	0	0
NOT COMPLETED	74	74
Death	1	2
Adverse Event	7	9
Lack of Efficacy	54	53
Withdrawal by Subject	6	1
still on treatment	3	1
insurance, symptomatic deterioration	1	3
Ineligible	2	5

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Arm I (Anastrozole and ZD1839)	Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
Arm II (Fulvestrant and ZD1839)	Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.

Baseline Measures

	Arm I (Anastrozole and ZD1839)	Arm II (Fulvestrant and ZD1839)	Total
Number of Participants [units: participants]	72	69	141
Age [units: years] Median ( Full Range )	58 ( 34 to 90 )	63 ( 35 to 91 )	59 ( 34 to 91 )
Gender [units: participants]
Female	72	69	141
Male	0	0	0
Region of Enrollment [units: participants]
United States	39	39	78
Peru	33	29	62
South Africa	0	1	1

Outcome Measures

1. Primary:

Clinical Benefit Rate [ Time Frame: assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
phone: 617-632-3012

No publications provided

Responsible Party:	Robert Comis, M.D., ECOG Group Chair's Office
ClinicalTrials.gov Identifier:	NCT00057941 History of Changes
Other Study ID Numbers:	CDR0000285631, U10CA021115, E4101
Study First Received:	April 7, 2003
Results First Received:	April 11, 2011
Last Updated:	April 11, 2011
Health Authority:	United States: Food and Drug Administration