Clinical trial · Interventional
S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
NCT00075764CI-TRIAL-00049401completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anastrozole | Drug | Anastrozole | ALIAS |
| fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients receive oral anastrozole once daily on days 1-28.
- interventionNames
- Drug: anastrozole
- type
- EXPERIMENTAL
- label
- Arm II
- description
- 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.
- interventionNames
- Drug: anastrozole
- Drug: fulvestrant
Primary outcomes (1)
- measure
- Time to Tumor Progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (4)
- DERIVEDBergqvist M, Nordmark A, Williams A, Paoletti C, Barlow W, Cobain EF, Mehta RS, Gralow JR, Hortobagyi GN, Albain KS, Pusztai L, Sharma P, Godwin AK, Thompson AM, Hayes DF, Rae JM. Thymidine kinase activity levels in serum can identify HR+ metastatic breast cancer patients with a low risk of early progression (SWOG S0226). Biomarkers. 2023 May;28(3):313-322. doi: 10.1080/1354750X.2023.2168063. Epub 2023 Jan 29. PMID 36647745
- DERIVEDMehta RS, Barlow WE, Albain KS, Vandenberg TA, Dakhil SR, Tirumali NR, Lew DL, Hayes DF, Gralow JR, Linden HH, Livingston RB, Hortobagyi GN. Overall Survival with Fulvestrant plus Anastrozole in Metastatic Breast Cancer. N Engl J Med. 2019 Mar 28;380(13):1226-1234. doi: 10.1056/NEJMoa1811714. PMID 30917258
- DERIVEDUnger JM, LeBlanc M, Blanke CD. The Effect of Positive SWOG Treatment Trials on Survival of Patients With Cancer in the US Population. JAMA Oncol. 2017 Oct 1;3(10):1345-1351. doi: 10.1001/jamaoncol.2017.0762. PMID 28586789
- DERIVEDMehta RS, Barlow WE, Albain KS, Vandenberg TA, Dakhil SR, Tirumali NR, Lew DL, Hayes DF, Gralow JR, Livingston RB, Hortobagyi GN. Combination anastrozole and fulvestrant in metastatic breast cancer. N Engl J Med. 2012 Aug 2;367(5):435-44. doi: 10.1056/NEJMoa1201622. PMID 22853014