COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer

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: NCT00049062
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 21, 2013
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in treating postmenopausal women who have metastatic breast cancer that has not responded to hormone therapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: anastrozole Drug: gefitinib Phase 2

Detailed Description:


  • Determine the antitumor activity of anastrozole and ZD 1839, as measured by objective response (partial or complete) or stable disease at 6 months, in post-menopausal women with estrogen receptor-positive, hormone refractory, metastatic breast cancer.
  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the safety of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Correlate molecular markers with clinical benefit in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients are stratified according to prior objective response to endocrine therapy (yes vs no).

Patients receive oral anastrozole once daily alone for 2 weeks. Patients then receive oral anastrozole and oral ZD 1839 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month and then monthly thereafter.

PROJECTED ACCRUAL: A total of 36-78 patients (18-39 per stratum) will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II And Biologic Correlative Study Investigating ARIMIDEX In Combination With IRESSA (ZD1839) In Post-Menopausal Patients With Estrogen Receptor-Positive Metastatic Breast Carcinoma Who Have Previously Failed Hormonal Therapy
Study Start Date : September 2002
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.

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


  • Histologically confirmed breast cancer

    • Metastatic or locally advanced unresectable disease
  • At least 1 measurable target lesion that has not been irradiated

    • New lesions in a previously irradiated field allowed as sites of measurable disease
  • Progressive disease after more than 2 months of aromatase inhibitor therapy
  • No known CNS disease or unevaluated CNS symptoms suggestive of brain metastases
  • Hormone receptor status:

    • Estrogen receptor or progesterone receptor positive



  • 18 and over


  • Female

Menopausal status

  • Post-menopausal by 1 of the following criteria:

    • Age 50 and over and has not menstruated during the past year or has castrate follicle-stimulating hormone (FSH) levels (greater than 40 IU/L)
    • Under age 50 and has castrate FSH levels
    • Received prior bilateral oophorectomy and has castrate FSH levels

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT or AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)


  • Creatinine no greater than 1.5 times ULN


  • No history of congestive heart failure requiring therapy
  • No ventricular arrhythmia requiring therapy
  • No unstable angina pectoris
  • No myocardial infarction within the past 6 months


  • Able to swallow oral medication
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No known malabsorption condition or other condition that would impair absorption of study drug
  • No active infection
  • No other concurrent medical condition that would preclude study
  • No known severe hypersensitivity to ZD 1839 or any excipients


Biologic therapy

  • Not specified


  • No prior chemotherapy except in adjuvant setting
  • No concurrent chemotherapy for breast cancer

Endocrine therapy

  • See Disease Characteristics
  • More than 30 days since other prior hormonal therapy (including hormone replacement therapy and megestrol)
  • Concurrent steroids for other reasons besides skin toxicity allowed
  • No other concurrent hormonal therapy (including megestrol) for breast cancer


  • See Disease Characteristics


  • Recovered from prior oncologic or other major surgery
  • No concurrent ophthalmic surgery


  • More than 30 days since prior anticancer therapy
  • More than 30 days since prior non-approved or investigational drugs
  • No prior epidermal growth factor receptor or HER2 blockers
  • No concurrent phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, Hypericum perforatum, or systemic retinoids
  • No other concurrent investigational therapy for breast cancer
  • Concurrent bisphosphonates for metastatic bone disease allowed

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): NCT00049062

Layout table for location information
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Layout table for investigator information
Study Chair: Eric K. Rowinsky, MD Cancer Therapy and Research Center, Texas
Publications of Results:
Mita M, de Bono JS, Mita A, et al.: A phase II and biologic correlative study investigating anastrozole (A) in combination with geftinib (G) in post menopausal patients with estrogen receptor positive (ER) metastatic breast carcinoma (MBC) who have previously failed hormonal therapy. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-1117, 2005.

Layout table for additonal information
Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT00049062    
Other Study ID Numbers: CDR0000257752
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013
Keywords provided by The University of Texas Health Science Center at San Antonio:
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs