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Completed

NCT Number: NCT00229697

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

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.

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Key information

Conditions

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

Age range

18 year–130 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Bahía Blanca, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib

Drug

Other names: Iressa

Tamoxifen

Drug

Other names: Nolvadex

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2015
First posted
Sep 30, 2005
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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