Status:
COMPLETED
S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 cli...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
695 Patients enrolled
Trial Details
Trial ID
NCT00075764
Start Date
April 1 2004
End Date
October 1 2018
Last Update
January 13 2021
Active Locations (426)
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1
Regional Medical Center
Anniston, Alabama, United States, 36202
2
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
3
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
4
Providence Cancer Center
Anchorage, Alaska, United States, 99508