Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 28, 2005

Last Updated Date

June 8, 2009

Start Date ^ICMJE

October 2003

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Strata 1: To compare the time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)
Strata 2: To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00229697 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 1 and overall
To compare time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 2 and overall
To compare the objective response rate between ZD1839/Nolvadex and placebo/Nolvadex in each strata and overall
To estimate duration of response for the ZD1839/Nolvadex and placebo/Nolvadex treatments in each strata and overall
To compare overall survival between the ZD1839/Nolvadex and placebo/Nolvadex in each strata
To assess whether patients with high tumour levels of HER-2 and/or AIB1 demonstrate de novo resistance to Nolvadex therapy or have shorter TTP or response duration when compared with Nolvadex/ZD1839 treatment
To compare the objective response rate between the ZD1839/Nolvadex and placebo/Nolvadex treatment arms in the subset of all patients with ER+ tumours staining 2+/3+ for Her2neu by IHC
To compare the safety and tolerability of ZD1839/Nolvadex to placebo/Nolvadex
To determine steady-state plasma trough concentrations of tamoxifen in all patients and to compare between the ZD1839/Nolvadex and placebo/Nolvadex treatment arms
To determine steady-state plasma trough concentrations of ZD1839 and relate values to historical data
To relate steady-state plasma trough concentrations of ZD1839 to demographic, response, and safety variables
To assess the quality of life (QOL) and symptom relief based on the Functional Assessment of Cancer Therapy - Breast (FACT-B) on both treatment arms
To investigate subject hospital resource use and health status
Characterization of specific adverse events
To obtain tumour tissue for biologic studies in this patient population

Original Secondary Outcome Measures ^ICMJE

- To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 1 and overall
- To compare time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 2 and overall
- To compare the objective response rate between ZD1839/Nolvadex and placebo/Nolvadex in each strata and overall
- To estimate duration of response for the ZD1839/Nolvadex and placebo/Nolvadex treatments in each strata and overall
- To compare overall survival between the ZD1839/Nolvadex and placebo/Nolvadex in each strata
- To assess whether patients with high tumour levels of HER-2 and/or AIB1 demonstrate de novo resistance to Nolvadex therapy or have shorter TTP or response duration when compared with Nolvadex/ZD1839 treatment
- To compare the objective response rate between the ZD1839/Nolvadex and placebo/Nolvadex treatment arms in the subset of all patients with ER+ tumours staining 2+/3+ for Her2neu by IHC
- To compare the safety and tolerability of ZD1839/Nolvadex to placebo/Nolvadex
- To determine steady-state plasma trough concentrations of tamoxifen in all patients and to compare between the ZD1839/Nolvadex and placebo/Nolvadex treatment arms
- To determine steady-state plasma trough concentrations of ZD1839 and relate values to historical data
- To relate steady-state plasma trough concentrations of ZD1839 to demographic, response, and safety variables
- To assess the quality of life (QOL) and symptom relief based on the Functional Assessment of Cancer Therapy – Breast (FACT-B) on both treatment arms
- To investigate subject hospital resource use and health status
- Characterization of specific adverse events
- To obtain tumour tissue for biologic studies in this patient population

Descriptive Information

Brief Title ^ICMJE

Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study

Official Title ^ICMJE

A Phase II Randomised, Double-Blind, Stratified, Multi-Centre Trial Comparing the Nolvadex 20 Mg And Placebo Combination To The Nolvadex 20 Mg and ZD1839 (IRESSA™) 250 MG Combination In Patients With Metastatic Breast Cancer And Estrogen Receptor (ER) and/or Progesterone (PR) Positive Tumours

Brief Summary

This study is being carried out to see if ZD1839 is effective in treating metastatic breast cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Breast Neoplasms

Intervention ^ICMJE

Drug: Gefitinib
Drug: Tamoxifen

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

274

Completion Date

December 2006

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologically confirmed metastatic adenocarcinoma of the breast (seeTNM staging Appendix I) that is ER and/or PR positive as determined in local laboratories at each investigator site (central verification of ER status will be performed after the patient starts treatment
A tissue block from either the metastatic or primary tumor site is required.
WHO performance status (PS) 0-2
Patients must not be pregnant or breast-feeding. A negative pregnancy test is required within 7 days prior to randomization if pre- or peri-menopausal. Postmenopausal patients are defined as:
natural menopause with last menses > 1 year ago,
radiation induced oophorectomy with last menses > 1 year ago,
chemotherapy induced menopause with 1 year interval since last menses, or
serum FSH and LH and plasma estradiol levels in the postmenopausal range for the institution.
bilateral oophorectomy

Exclusion Criteria:

Patients cannot be on hormone replacement therapy or received prior chemotherapy for metastatic disease.
Patients previously treated with a Tyrosine Kinase inhibitor or have evidence of an active interstitial lung disease are not eligible.
Treatment with LH-RH analog.
Laboratory values as follow Bilirubin >1.5 times upper limit of normal ULN, alanine amino transferase (ALT) or aspartate amino transferase (AST) >2.5 times the ULN if no demonstrable liver metastases, or >5 times the ULN in the presence of liver metastases
Bone marrow function: WBC <1500 mm3

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, South Africa, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00229697

Responsible Party

Study ID Numbers ^ICMJE

1839IL/0225, D7917C00225

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Iressa Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP