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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00206492
Recruitment Status : Terminated (halted by the PI only 3 of 45 subjects were accrued.)
First Posted : September 21, 2005
Last Update Posted : August 1, 2017
Information provided by (Responsible Party):
Baylor Breast Care Center

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Iressa Drug: Tamoxifen Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : July 2003
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Iressa and Tamoxifen
Iressa and Tamoxifen
Drug: Iressa
Other Name: ZD1839

Drug: Tamoxifen

Primary Outcome Measures :
  1. cellular response [ Time Frame: 10 years ]
    mechanisms of the cellular response, markers predicting response, by investigating whether ZD1839 with or without tamoxifen treatment is associated with altered biomarkers in cells isolated by core needle biopsy

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00206492

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United States, Texas
Baylor Breast Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor Breast Care Center
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Principal Investigator: Jenny Chang, MD Baylor Breast Center
Additional Information:
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Responsible Party: Baylor Breast Care Center Identifier: NCT00206492    
Other Study ID Numbers: H 13546
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Keywords provided by Baylor Breast Care Center:
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
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