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

NCT00229697 | Completed Phase 2

• 2 other identifiers: 1839IL/0225D7917C00225
• Study Type: interventional
• Target: 317
• Locations: 12 countries
• Sites: 55

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.

Conditions

Breast Neoplasms

Keywords

Breast cancer; metastatic breast cancer

Outcome Measures

Primary Outcomes (2)

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

  Time to progression (progressive disease or death; equivalent to progression-free survival)

• Strata 2: To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)

  Overall clinical benefit rate: Complete Response, Partial Response or Stable Disease > 24weeks after each combination

Secondary Outcomes (15)

• To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 1 and overall

  Overall clinical benefit rate: Complete Response, Partial Response or Stable Disease >24 weeks after each combination. Objective tumour resp defined according to RECIST criteria

• To compare time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 2 and overall

  Time to progression (progressive disease or death)

• To compare the objective response rate between ZD1839/Nolvadex and placebo/Nolvadex in each strata and overall

  Objective tumour response (OR) defined according to RECIST criteria

• To estimate duration of response for the ZD1839/Nolvadex and placebo/Nolvadex treatments in each strata and overall

  Duration of response (CR and PR)

• To compare overall survival between the ZD1839/Nolvadex and placebo/Nolvadex in each strata

  Overall survival

Study Arms (2)

1

EXPERIMENTAL

ZD1839 + Nolvadex

Drug: Gefitinib; Drug: Tamoxifen

2

OTHER

Nolvadex + placebo

Drug: Tamoxifen

Interventions

Gefitinib DRUG

Also known as: Iressa

1

Tamoxifen DRUG

Also known as: Nolvadex

1; 2

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (55)

Research Site

Berkeley, California, United States

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Palm Springs, California, United States

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St Louis, Missouri, United States

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New York, New York, United States

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Bahía Blanca, Argentina

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Ciudad de Buenos Aires, Argentina

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Córdoba, Argentina

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El Palomar, Argentina

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Resistencia, Argentina

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Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Santa Fe, Argentina

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Vicente López, Argentina

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Bentleigh East, Australia

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Newcastle, Australia

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Randwick, Australia

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Westmead, Australia

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Wodonga, Australia

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Brussels, Belgium

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Leuven, Belgium

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Wilrijk, Belgium

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Belo Horizonte, Brazil

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Curitiba, Brazil

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Porto Alegre, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Saint John, New Brunswick, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Herlev, Denmark

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Lyon, France

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Mougins, France

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Poitiers, France

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Rouen, France

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Frankfurt, Germany

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Jena, Germany

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Kiel, Germany

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München, Germany

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Trier, Germany

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Durban, South Africa

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Johannesburg, South Africa

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Klerksdorp, South Africa

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Observatory, South Africa

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Barcelona, Spain

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Córdoba, Spain

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Madrid, Spain

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Majadahonda, Spain

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Zaragoza, Spain

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Colchester, United Kingdom

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Dundee, United Kingdom

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Manchester, United Kingdom

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Nottingham, United Kingdom

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Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gefitinib; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• AstraZeneca Iressa Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2005
• First Posted: September 30, 2005
• Study Start: October 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: June 1, 2015
• Last Updated: October 5, 2015

Record last verified: 2015-10

Locations

AU (5); FR (4); ZA (4); BR (4); CA (7); DK (1); ES (5); AR (9); US (4); GB (4); DE (5); BE (3)