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

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ClinicalTrials.gov Identifier: NCT00229697
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Gefitinib Drug: Tamoxifen Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
ZD1839 + Nolvadex
 Drug: Gefitinib
Other Name: Iressa

Drug: Tamoxifen
Other Name: Nolvadex
2
Nolvadex + placebo
 Drug: Tamoxifen
Other Name: Nolvadex


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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) ]
  3. 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 ]
  4. 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) ]
  5. To compare overall survival between the ZD1839/Nolvadex and placebo/Nolvadex in each strata [ Time Frame: Overall survival ]
  6. 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) ]
  7. 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 ]
  8. To compare the safety and tolerability of ZD1839/Nolvadex to placebo/Nolvadex [ Time Frame: Safety (frequency and severity of adverse events) ]
  9. 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 ]
  10. To determine steady-state plasma trough concentrations of ZD1839 and relate values to historical data [ Time Frame: ZD1839 (Cmin) steady-state plasma concentration ]
  11. To relate steady-state plasma trough concentrations of ZD1839 to demographic, response, and safety variables [ Time Frame: ZD1839 (Cmin) steady-state plasma concentration ]
  12. 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) ]
  13. To investigate subject hospital resource use and health status [ Time Frame: Hospitalisations and EQ-5D ]
  14. Characterization of specific adverse events [ Time Frame: Characterization of adverse events such as alopecia, rash and diarrhea ]
  15. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00229697


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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00229697     History of Changes
Obsolete Identifiers: NCT00069290
Other Study ID Numbers: 1839IL/0225
D7917C00225
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015
Keywords provided by AstraZeneca:
Breast cancer
metastatic breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Gefitinib
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action