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STUDY RANDOMIZED PHASE II, COMBINATION OF ANASTROZOL (NSC 719344) MAS ZD1839 (IRESSA, NSC No. 715055, IND No. 61187) AND THE COMBINATION OF FULVESTRANT (NSC · 719276) MAS ZD1839 IN THE TREATMENT OF POSTMENOPAUS WOMEN WITH CANCER OF METASTASIC MAMA AND POSITIVE HORMONAL RECEPTORS

STUDY RANDOMIZED PHASE II, COMBINATION OF ANASTROZOL (NSC 719344) MAS ZD1839 (IRESSA, NSC No. 715055, IND No. 61187) AND THE COMBINATION OF FULVESTRANT (NSC · 719276) MAS ZD1839 IN THE TREATMENT OF POSTMENOPAUS WOMEN WITH CANCER OF METASTASIC MAMA AND POSITIVE HORMONAL RECEPTORS.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-101-03
Enrollment
Unknown
Registered
2004-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Anastrozole Type of group
Anastrozole: 1 mg daily + ZD 1839: 500 mg daily Group name:Fulvestrant Type of group
Fulvestrant
250 mg on day 1 every 4 weeks + ZD1839: 500 mg dally

Sponsors

EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients must have estrogen and/or progesterone receptor positive histologically confirmed adenocartinoma of the breast with measurable recurrent or metastatic carcinoma of the breast.

Exclusion criteria

Exclusion criteria: not contemplated

Design outcomes

Primary

MeasureTime frame
Outcome name:To assess objective responso, it Is necessary to estimate the overali tumor burden at baseline to which subsequent measurements wiil be compared. Measurable disease Is defined by the presence of at least one measurable lesion. Measure:Malianant Disease Evaluation Timepoints:4 weeks—

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated—

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)