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A Phase II, Randomised, Double-Blind, Placebocontrolled Study To Investigate The Effects Of ZD1839 (IRESSA™) On Cell Proliferation In Oestrogen And Progesterone Receptor Negative Breast Cancer Prior To Surgery


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase II, Randomised, Double-Blind, Placebocontrolled Study To Investigate The Effects Of ZD1839 (IRESSA™) On Cell Proliferation In Oestrogen And Progesterone Receptor Negative Breast Cancer Prior To Surgery


Inclusion Criteria:



- Histologically-confirmed ER- and PgR- primary breast cancer

- Stage T .5 cm, N0-1, M0

- No previous treatment for breast cancer

Exclusion Criteria:

- ALT or AST greater than 2.5 times the ULRR

- Metastatic disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Estimate the effect of ZD1839 compared with placebo on the change in tumour cell proliferation in patients who have completely ER negative & PgR negative breast cancer

Principal Investigator

AstraZeneca Italy Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

1839IL/0509

NCT ID:

NCT00252811

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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