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

Tracking Information
First Submitted Date  ICMJE November 12, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date February 21, 2013
Study Start Date  ICMJE September 2002
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer
Official Title  ICMJE 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
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.

Detailed Description

OBJECTIVES:

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: anastrozole
  • Drug: gefitinib
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • 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

Hematopoietic

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

Hepatic

  • 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)

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

  • See Disease Characteristics

Surgery

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

Other

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00049062
Other Study ID Numbers  ICMJE CDR0000257752
CTRC-IDD-0219
CTRC-IDD-1839US
CTRC-IDD-0228
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Eric K. Rowinsky, MD Cancer Therapy and Research Center, Texas
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP