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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00229697
First received: September 28, 2005
Last updated: June 11, 2014
Last verified: June 2014

September 28, 2005
June 11, 2014
October 2003
December 2006   (final data collection date for primary outcome measure)
  • Strata 1: To compare the time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) [ Time Frame: Time to progression (progressive disease or death; equivalent to progression-free survival) ] [ Designated as safety issue: No ]
  • Strata 2: To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) [ Time Frame: Overall clinical benefit rate: Complete Response, Partial Response or Stable Disease > 24weeks after each combination ] [ Designated as safety issue: No ]
  • 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)
Complete list of historical versions of study NCT00229697 on ClinicalTrials.gov Archive Site
  • To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 1 and overall [ Time Frame: Overall clinical benefit rate: Complete Response, Partial Response or Stable Disease >24 weeks after each combination. Objective tumour resp defined according to RECIST criteria ] [ Designated as safety issue: No ]
  • To compare time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 2 and overall [ Time Frame: Time to progression (progressive disease or death) ] [ Designated as safety issue: No ]
  • To compare the objective response rate between ZD1839/Nolvadex and placebo/Nolvadex in each strata and overall [ Time Frame: Objective tumour response (OR) defined according to RECIST criteria ] [ Designated as safety issue: No ]
  • To estimate duration of response for the ZD1839/Nolvadex and placebo/Nolvadex treatments in each strata and overall [ Time Frame: Duration of response (CR and PR) ] [ Designated as safety issue: No ]
  • To compare overall survival between the ZD1839/Nolvadex and placebo/Nolvadex in each strata [ Time Frame: Overall survival ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Time to progression (progressive disease or death), duration of response (CR and PR) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Objective tumour response (OR) defined according to RECIST criteria ] [ Designated as safety issue: No ]
  • To compare the safety and tolerability of ZD1839/Nolvadex to placebo/Nolvadex [ Time Frame: Safety (frequency and severity of adverse events) ] [ Designated as safety issue: Yes ]
  • To determine steady-state plasma trough concentrations of tamoxifen in all patients and to compare between the ZD1839/Nolvadex and placebo/Nolvadex treatment arms [ Time Frame: Tamoxifen (Cmin) steady-state plasma concentration ] [ Designated as safety issue: No ]
  • To determine steady-state plasma trough concentrations of ZD1839 and relate values to historical data [ Time Frame: ZD1839 (Cmin) steady-state plasma concentration ] [ Designated as safety issue: No ]
  • To relate steady-state plasma trough concentrations of ZD1839 to demographic, response, and safety variables [ Time Frame: ZD1839 (Cmin) steady-state plasma concentration ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: FACT-B questionnaire, FBSI (FACT-B Symptom Index) ] [ Designated as safety issue: No ]
  • To investigate subject hospital resource use and health status [ Time Frame: Hospitalisations and EQ-5D ] [ Designated as safety issue: No ]
  • Characterization of specific adverse events [ Time Frame: Characterization of adverse events such as alopecia, rash and diarrhea ] [ Designated as safety issue: Yes ]
  • To obtain tumour tissue for biologic studies in this patient population [ Time Frame: ER receptor, ErbB-1 &2 (immunohistochemistry) and other biological markers including Her2/neu, AIB1 ] [ Designated as safety issue: No ]
  • - 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
Not Provided
Not Provided
 
Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: Gefitinib
    Other Name: Iressa
  • Drug: Tamoxifen
    Other Name: Nolvadex
  • Experimental: 1
    ZD1839 + Nolvadex
    Interventions:
    • Drug: Gefitinib
    • Drug: Tamoxifen
  • 2
    Nolvadex + placebo
    Intervention: Drug: Tamoxifen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
274
December 2014
December 2006   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   France,   Germany,   South Africa,   Spain,   United Kingdom
 
NCT00229697
1839IL/0225, D7917C00225
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
AstraZeneca
June 2014

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