Trial of ZD1839 (Iressa) and Tamoxifen in Breast Cancer Patients - Full Text View

Sponsors and Collaborators:	Baylor Breast Care Center AstraZeneca
Information provided by:	Baylor Breast Care Center
ClinicalTrials.gov Identifier:	NCT00206492

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: ZD1839 Tamoxifen Tamoxifen citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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)

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:	July 2010

Intervention Details:

Iressa

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:

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.

Exclusion Criteria:

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.

Contacts and Locations

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

Web site

This link exits the ClinicalTrials.gov site

Responsible Party:	Baylor College of Medicine ( Jenny Chang )
Study ID Numbers:	H 13546
Study First Received:	September 14, 2005
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00206492
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor Breast Care Center:

Breast
Cancer
Neoadjuvant
HER2
Overexpressing

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Tamoxifen
Gefitinib
Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Protein Kinase Inhibitors
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009