Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00077025
• Date of registration: 09/02/2004
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer
• Scientific title: Phase II Multicenter, Double-Blind, Randomized Trial Comparing Anastrozole (ZD1033, Arimidex™)-Placebo to the Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer
• Date of first enrolment: January 2004
• Target sample size: 174
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00077025
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Colombia, Mexico, United States, Venezuela

Contacts

• Name: Iressa Medical Science Director, MD
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female postmenopausal patients aged 18 years or older with newly diagnosed metastatic
breast cancer.

- Patients with recurrent disease during or after adjuvant tamoxifen or patients who
are hormone therapy naïve are eligible for this trial.

- A paraffin embedded tumor tissue block or slides from either the metastatic or
primary tumor site is required.

Exclusion Criteria:

- Patients cannot be on hormone replacement therapy while on study.

- Prior chemotherapy received for metastatic disease is not allowed.

- Previous treatment with tyrosine kinase inhibitors or aromatase inhibitors is not
allowed.

- Patients who have evidence of an active interstitial lung disease are not eligible.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Gefitinib

Drug: Anastrozole

Primary Outcome(s)

Time to progression [Time Frame: Duration of study]

Secondary Outcome(s)

Objective response rate [Time Frame: Duration of Study]

Overall clinical benefit rate [Time Frame: Duration of Study]

Overall survival [Time Frame: Duration of Study]

Pharmacokinetic variables [Time Frame: Duration of Study]

Biomarker objectives [Time Frame: Duration of Study]

Safety [Time Frame: Duration of Study]

Secondary ID(s)

1839US/0713

Source(s) of Monetary Support

Please refer to primary and secondary sponsors