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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00077025
First received: February 9, 2004
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Gefitinib
Drug: Anastrozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to progression [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
    To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer


Secondary Outcome Measures:
  • Objective response rate [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
    To estimate the ORR (complete response [CR] and partial response [PR] as defined by RECIST for the 2 treatment arms

  • Overall clinical benefit rate [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
    To estimate the clinical benefit rates (CBR; defined as CR+PR[as per RECIST]+stable disease [SD]>24 weeks) for the 2 treatment arms

  • Overall survival [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
    To estimate overall survival (OS) for each of the 2 treatment arms

  • Safety [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]
    To compare the tolerability of anastrozole/placebo to that of anastrozole/ZD1839

  • Pharmacokinetic variables [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
    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

  • Biomarker objectives [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 174
Study Start Date: January 2004
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077025

  Show 27 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Iressa Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00077025     History of Changes
Other Study ID Numbers: 1839US/0713
Study First Received: February 9, 2004
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Anastrozole
Estrogens
Gefitinib
Progesterone
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Progestins
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014