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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077025
Recruitment Status : Completed
First Posted : February 11, 2004
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):

Brief Summary:
This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Gefitinib Drug: Anastrozole Phase 2

Detailed Description:
This is a phase II, multicenter, double-blind, randomized, placebo-controlled trial. Patients will be randomized in a double-blind manner in a 1:1 ratio to receive either 250 mg/day ZD1839 or matched placebo in combination with 1 mg/day anastrozole. The dose of ZD1839 has been selected based on clinical studies in other tumor types suggesting identical efficacy together with a better toxicity profile in patients treated at 250 mg compared to 500 mg/day. The 1 mg dose of anastrozole is the standard approved dose.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2004
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Anastrozole-placebo
Anastrozole (ZD1033, Arimidex)-Placebo
Drug: Anastrozole
1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO
Other Name: Arimidex
Active Comparator: Anastrozole-ZD1839
Anastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA)
Drug: Gefitinib
ZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex)
Other Name: IRESSA

Primary Outcome Measures :
  1. Time to progression [ Time Frame: Duration of study ]
    To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Duration of Study ]
    To estimate the ORR (complete response [CR] and partial response [PR] as defined by RECIST for the 2 treatment arms

  2. Overall clinical benefit rate [ Time Frame: Duration of Study ]
    To estimate the clinical benefit rates (CBR; defined as CR+PR[as per RECIST]+stable disease [SD]>24 weeks) for the 2 treatment arms

  3. Overall survival [ Time Frame: Duration of Study ]
    To estimate overall survival (OS) for each of the 2 treatment arms

  4. Safety [ Time Frame: Duration of Study ]
    To compare the tolerability of anastrozole/placebo to that of anastrozole/ZD1839

  5. Pharmacokinetic variables [ Time Frame: Duration of Study ]
    To determine steady-state plasma trough concentrations of anastrozole in all patients. To determine steady-state trough concentrations of ZD1839 and to relate values to historical data

  6. Biomarker objectives [ Time Frame: Duration of Study ]
    To obtain tumor tissue and blood samples for biologic studies in the limited population available and measure expression of markers that may potentially correlate with response to treatment in this patient population

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077025

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Sponsors and Collaborators
Study Director: Iressa Medical Science Director, MD AstraZeneca

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00077025     History of Changes
Other Study ID Numbers: 1839US/0713
First Posted: February 11, 2004    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by AstraZeneca:
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists