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

NCT00206492 | Terminated Phase 2

• 1 other identifier: H 13546
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

Breast; Cancer; Neoadjuvant; HER2; Overexpressing

Outcome Measures

Primary Outcomes (1)

• cellular response

  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

  10 years

Study Arms (1)

Iressa and Tamoxifen

EXPERIMENTAL

Iressa and Tamoxifen

Drug: Iressa; Drug: Tamoxifen

Interventions

Iressa DRUG

Iressa

Also known as: ZD1839

Iressa and Tamoxifen

Tamoxifen DRUG

Tamoxifen

Iressa and Tamoxifen

Eligibility Criteria

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

You may qualify if:

• All patients must be female and must have signed an informed consent form.
• 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.
• Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.
• 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.
• Renal function tests:
• creatinine within 1.5 times the institution's upper limit of normal (ULN).
• Liver function tests:
• Total serum bilirubin within ULN,
• liver transaminases within 2.5 x ULN,
• alkaline phosphatase within 5 x ULN.
• Performance status (WHO scale) \<2.
• Age \> 18 years.

You may not qualify if:

• Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
• Women who are lactating or breastfeeding.
• Severe underlying chronic illness or disease.
• Patients on other investigational drugs while on study will be excluded.
• Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease.
• 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.
• Any evidence of ongoing interstitial lung disease.
• Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
• Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
• Known severe hypersensitivity to ZD1839 or any of the excipients of this product.

Sponsors & Collaborators

• Baylor Breast Care Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Baylor Breast Center

Houston, Texas, 77030, United States

Location

Related Links

• Web site

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Gefitinib; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; 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

• Jenny Chang, MD

  Baylor Breast Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2003
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

US (1)