Trial of ZD1839 (Iressa) and Tamoxifen in Breast Cancer Patients

This study has been withdrawn prior to enrollment.
(Due to poor accrual the study was halted by the PI only 3 of 45 subjects were accrued.)
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00206492
First received: September 14, 2005
Last updated: September 9, 2010
Last verified: September 2010
  Purpose

The researchers want to learn whether ZD1839 can improve the activity of tamoxifen, a drug that participants will receive for the treatment of the type of breast cancer being studied. Tamoxifen medicine is part of the standard treatment for the type of breast cancer being studied. It is approved for the treatment of this problem. In order to help the researchers understand how the cancer responds to these medicines, the researchers will take a small tissue sample (biopsy) of the breast cancer before beginning treatment and after two weeks of treatment, at 6 weeks and when surgery is done as part of treatment for the cancer. If participants do not respond to treatment, another biopsy will be done to see why the participants did not respond. These samples will also be collected to look at different characteristics of the cancer. The researchers cannot and do not guarantee that participants will benefit if they take part in this study


Condition Intervention Phase
Breast Cancer
Drug: Iressa
Drug: Tamoxifen
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Neoadjuvant Phase II Trial of ZD1839 (Iressa) and Tamoxifen in Inoperable Locally Advanced HER2-Overexpressing, ER-Positive Breast Cancer Patients: Biologic Correlative Study (AZ #1839US/0303)

Resource links provided by NLM:


Further study details as provided by Baylor Breast Care Center:

Primary Outcome Measures:
  • mechanisms of the cellular response, markers predicting response, by investigating whether ZD1839 with or without tamoxifen treatment is associated with altered expression of specific biomarkers in cells isolated by core needle biopsy [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2003
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Iressa
    Iressa
    Drug: Tamoxifen
    Tamoxifen
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients must be female and must have signed an informed consent form.
  2. Primary breast cancers must be human epidermal growth factor receptor (HER2) overexpressing (2+ or 3+, or both, as determined by immunohistochemistry [IHC]), and estrogen receptor (ER) positive. Primary breast cancers must be of clinical and/or radiologic size >4 cm, with or without gross metastatic disease according to the International Union against Cancer (UICC) modified World Health Organization (WHO) criteria.
  3. Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.
  4. Adequate bone marrow function:

    • Hematocrit >30%,
    • total neutrophil count must be >1.5 x 10^9/L, and
    • platelet count >100 x 10^9/L.
  5. Renal function tests:

    • creatinine within 1.5 times the institution's upper limit of normal (ULN).
  6. Liver function tests:

    • Total serum bilirubin within ULN,
    • liver transaminases within 2.5 x ULN,
    • alkaline phosphatase within 5 x ULN.
  7. Performance status (WHO scale) <2.
  8. Age > 18 years.

Exclusion Criteria:

  1. Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
  2. Women who are lactating or breastfeeding.
  3. Severe underlying chronic illness or disease.
  4. Patients on other investigational drugs while on study will be excluded.
  5. Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease.
  6. No previous or current malignancies at other sites within the preceding 5 years, with the exception of adequately treated, cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
  7. Any evidence of ongoing interstitial lung disease.
  8. Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
  9. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  10. Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206492

Locations
United States, Texas
Baylor Breast Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor Breast Care Center
AstraZeneca
Investigators
Principal Investigator: Jenny Chang, MD Baylor Breast Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jenny Chang, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00206492     History of Changes
Other Study ID Numbers: H 13546
Study First Received: September 14, 2005
Last Updated: September 9, 2010
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Baylor Breast Care Center:
Breast
Cancer
Neoadjuvant
HER2
Overexpressing

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Gefitinib
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014