Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
anastrozole
+ fulvestrant
Breast Diseases+2
+ Breast Neoplasms
+ Neoplasms
Treatment Study
Summary
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: * Compare the time to tumor progression in postmenopausal women with metastatic breast cancer treated with anastrozole with or without fulvestrant as first-line therapy. * Compare the clinical benefit (complete or partial response, confirmed or unconfirmed, or stable disease ≥ 24 weeks) and overall survival of patients treated with these regimens. * Compare adverse events in patients treated with these regimens. * Determine the prognostic significance of estrogen receptor positivity and HER2/neu status in patients treated with these regimens. * Determine parameters of estrogen and clinical pharmacology and estrogen levels in patients treated with these regimens. * Compare anastrozole plasma levels at 8, 16, and 24 weeks in patients treated with these regimens (closed as of 4/16/2009). * Compare estradiol serum levels at 8, 16, and 24 weeks in patients treated with these regimens (closed as of 4/16/2009). OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant tamoxifen therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral anastrozole once daily on days 1-28. * Arm II: Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for up to 4 years. PROJECTED ACCRUAL: A total of 690 patients (345 per treatment arm) will be accrued for this study within 3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.695 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer meeting 1 of the following criteria: * Metastatic disease (M1) * Multiple sites of new disease that is clinically obvious metastatic disease (e.g., multiple sites of new osseous disease) * Measurable or nonmeasurable disease * No known brain or CNS metastases * Hormone receptor status: * Estrogen-receptor positive\* AND/OR * Progesterone-receptor positive\* NOTE: \*Positivity defined as estrogen binding of \> 10 fmol/mg cytosol protein by ligand binding assay or positive by immunohistochemistry PATIENT CHARACTERISTICS: Age * Not specified Sex * Female Menopausal status * Postmenopausal, as defined by 1 of the following: * Prior bilateral oophorectomy * More than 12 months since last menstrual period with no prior hysterectomy * At least 55 years of age with prior hysterectomy * Under 55 years of age with a prior hysterectomy without oophorectomy and with estradiol and follicle-stimulating hormone levels consistent with menopause Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency) Hepatic * INR ≤ 1.6 Renal * Not specified Other * HIV negative * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for recurrent or metastatic disease Chemotherapy * No prior chemotherapy for recurrent or metastatic disease * More than 12 months since prior adjuvant or neoadjuvant chemotherapy * No concurrent chemotherapy for malignancy Endocrine therapy * Prior adjuvant hormonal therapy allowed * At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH) analogues * Menstrual periods must not have resumed since LHRH therapy * More than 12 months since prior adjuvant or neoadjuvant aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) * More than 12 months since prior fulvestrant * No prior hormonal therapy for recurrent or metastatic disease * No other concurrent hormonal therapy for malignancy * No concurrent hormone replacement therapy Radiotherapy * Not specified Surgery * Not specified Other * No long-term anticoagulant therapy (except antiplatelet therapy)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 425 locations
Providence Cancer Center at Providence Hospital
Mobile, United StatesAlaska Regional Hospital Cancer Center
Anchorage, United StatesProvidence Cancer Center
Anchorage, United States