Clinical trial · Interventional

Ph II Early BC Pre-Surgical Biologic Study

A PreSurgical Study to Evaluate Molecular Alterations That Occur in Human Breast Cancer Tissue and Normal Skin After Short Term Exposure to ZD1839 (IRESSA) and to Correlate These Alterations With Pharmacokinetic Parameters.

NCT00637026CI-TRIAL-00002241completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

A pre-surgery study to assess changes that occur in human breast cancer material and normal skin after a short course of treatment with Iressa.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Gefitinib	Drug	Gefitinib	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Molecular alterations occuring in breast cancer tissue following Iressa treatment
timeFrame
At time of diagnosis and time of patient surgery

Secondary outcomes (3)

measure
Molecular alterations occurring in normal skin tissue following Iressa treatment
timeFrame
At time of diagnosis and time of patient surgery
measure
To correlate molecular changes with pharmacokinetic parameters
timeFrame
At time of diagnosis and time of patient surgery
measure
To evaluate tolerability of short term Iressa treatment

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Invasive breast cancer, Aged 18 years or older, Not more than 28 days from initial diagnosis

Exclusion Criteria:

* Pregnant or lactating patients, Prior or current radiotherapy for breast cancer, Known allergy reaction to Iressa

References

Publications (0)

Data not yet available

No reference posted for this study.