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

NCT00049062 | Completed Phase 2

• 4 other identifiers: CDR0000257752CTRC-IDD-0219CTRC-IDD-1839USCTRC-IDD-0228
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Interventions

anastrozole DRUG

gefitinib DRUG

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Eric K. Rowinsky, MD

  Cancer Therapy and Research Center, Texas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

US (1)