Phase II Study of Liarozole Fumarate for Unresectable or Metastatic Breast Cancer (Summary Last Modified 07/98)
Liarozole in Treating Women With Unresectable or Metastatic Breast Cancer
Basic Trial Information
I. Evaluate whether partial or complete responses can be achieved with liarozole fumarate in patients with advanced breast cancer. II. Assess the probability of an actual response rate warranting further evaluation of therapeutic effectiveness in the event of partial or complete responses to liarozole fumarate in this patient population. III. Characterize the safety and tolerance to liarozole fumarate in these patients.
Histologically or cytologically verified breast cancer that is unresectable or metastatic in the following hormone receptor/prior therapy categories: ER positive, tamoxifen-refractory, i.e.: Relapsed on adjuvant tamoxifen within 1 year of beginning treatment OR Clearly progressive within 4 months of beginning tamoxifen as first-line therapy for recurrent disease ER negative: Maximum of 1 prior regimen for metastatic disease (chemotherapy or hormonal therapy) Prior adjuvant chemotherapy or hormonal therapy allowed ER positive or unknown that has shown benefit to 1 or 2 prior hormonal therapies (including tamoxifen), i.e.: Prior objective response to hormonal therapy No change during at least 6 months of endocrine therapy Disease-free for at least 1 year (for ER positive) or 2 years (for ER unknown) following adjuvant hormonal therapy (adjuvant chemotherapy allowed) Hormone receptor status should be measured at study entry (if more than 1 value is available, status is determined by the most recent one obtained while off hormonal therapy) ER-positive defined as at least 10 femtomoles/mg cytosol protein Uni- or bidimensionally measurable disease required, e.g.: Skin nodule Lung lesion at least 15 mm and completely or partially surrounded by aerated lung Lytic bone lesion at least 10 mm in 2 diameters or at least 15 mm in 1 diameter and assessable by conventional x-ray, CT, or MRI Abdominal or soft tissue mass that is palpable and measurable Mediastinal or hilar involvement in which normal width (preinvolvement) can be subtracted from pretreatment width on chest x-ray Irregular skin metastases and lymphangitic cutaneous spread ("cancer en cuirasse") with adequate clinical photograph Liver lesion at least 20 mm in 2 diameters or 25 mm in 1 diameter on CT New lesion in previously irradiated field The following are not considered uni- or bidimensionally measurable but may be used in overall assessment: Previously irradiated lesion Ascites Pleural effusion Osteoblastic or mixed bone metastases Abdominal lesion that is palpable but not measurable Hepatomegaly The following are not acceptable as sole manifestation of disease: Lymphedema Pleural effusion Ascites Osteoblastic skeletal lesions Liver metastases as sole site of recurrent disease No brain or leptomeningeal metastases No rapidly progressing, life-threatening metastases
See Disease Characteristics Recovery from prior therapy required Prior radiotherapy allowed (no delay prior to entry) No concurrent experimental drugs or steroids
Age: Any age Sex: Females only Menopausal status: Postmenopausal, i.e.: Amenorrheic for at least 12 months regardless of age Amenorrheic and age 56 or over Serum FSH and estradiol levels within normal menopausal range on 2 determinations at least 1 week apart (at least 4 weeks after cessation of oral contraceptives) Performance status: WHO 0-3 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dL (25 micromoles/L) AST no greater than twice normal (3 times normal if liver metastases) Renal: Creatinine no greater than 2.0 mg/dL (175 micromoles/L) Other: No active uncontrolled infection No poor medical risk due to nonmalignant systemic disease No prior or current second malignancy except: Primary breast cancer Adequately treated basal cell skin cancer Adequately treated localized squamous cell skin cancer Cone-biopsied in situ cervical cancer No pregnant or nursing women
Up to 29 patients will be accrued. If no response is seen in the first 16 patients, accrual will cease.
All patients receive liarozole fumarate daily by mouth for at least 8 weeks. The dose may be increased once after 2 weeks if treatment is well tolerated. Therapy may continue until disease progression outside the brain intervenes. Radiotherapy to nonindicator lesions for palliation of painful bone metastases is allowed. No concomitant investigational drugs are allowed. Patients are assessed for response every 8 weeks and followed for survival.
Hamilton A, Roy JA, Beex L, et al.: EORTC 10941: A phase II study of liarozole in postmenopausal patients with 'chemotherapy-resistant' or 'potentially hormone sensitive' metastatic breast cancer. Breast Cancer Res Treat 60 (2): 181-8, 2000.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
European Organization for Research and Treatment of Cancer
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.