NCT00075764
S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer
PHASE3
COMPLETED
NCT00075764
INTERVENTIONAL
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer.
PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.
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)
Breast Cancer
- TREATMENT
-
- Type: DRUG
- Name: anastrozole
- Description: Given orally
- Arm Group Labels: Arm I, Arm II
-
- Type: DRUG
- Name: fulvestrant
- Description: Given intramuscularly
- Arm Group Labels: Arm II
- SWOG Cancer Research Network