Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Aromatase Inhibitors; Estrogen Antagonists; Estrogen Receptor Modulators; Gefitinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Radiological and/or clinical evidence of metastatic disease

• Progressive disease after prior therapy with an antiestrogen (e.g., tamoxifen or faslodex) and a nonsteroidal aromatase inhibitor (e.g., anastrozole or letrozole) in the adjuvant and/or metastatic setting* NOTE: *Endocrine therapy must be the last treatment before study entry

• Unidimensionally measurable disease

• No rapidly progressive visceral metastases

• No uncontrolled CNS metastases

• Hormone receptor status:

• Estrogen receptor and/or progesterone receptor positive

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Not specified

Menopausal status

• Postmenopausal, defined as any of the following:

• Natural menopause with at least 1 year since last menses

• Radiation-induced oophorectomy with last menses more than 1 year ago

• Chemotherapy-induced menopause with 1 year since last menses and serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels in the postmenopausal range

• Surgical castration

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Transaminases no greater than 2.5 times ULN

• No severe or uncontrolled hepatic disease

Renal

• No severe or uncontrolled renal disease

Cardiovascular

• No severe or uncontrolled cardiac disease

Pulmonary

• No severe or uncontrolled respiratory disease

• No evidence of clinically active interstitial lung disease

• Asymptomatic chronic stable radiographic changes allowed

Other

• No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, contralateral breast cancer, or nonmelanoma skin cancer

• No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

• No other severe or uncontrolled systemic disease

• No known hypersensitivity to any excipients of gefitinib

• No unresolved chronic toxicity greater than grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent biologic agents

Chemotherapy

• No more than 1 prior chemotherapy regimen for metastatic breast cancer

• No concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics

• No concurrent hormonal therapy

Radiotherapy

• Prior radiotherapy allowed

• No concurrent radiotherapy to any metastatic site

Surgery

• No surgery within 4 days after study drug administration

Other

• No prior epidermal growth factor receptor inhibitor therapy

• More than 30 days since prior investigational drugs

• No concurrent use of any of the following:

• Phenytoin

• Carbamazepine

• Rifampin

• Phenobarbital

• Hypericum perforatum (St. John's Wort)

• No concurrent systemic retinoids

• No other concurrent investigational drugs or treatments

• No other concurrent anticancer treatments

• Concurrent bisphosphonates for the treatment and prevention of bony metastases are allowed provided therapy was initiated before study enrollment* NOTE: *Bisphosphonates may be initiated during study participation for the treatment of hypercalcemia only