- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00253422
Fulvestrant With or Without Anastrozole or Exemestane Alone in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
A Partially-Blind Phase III Randomized Trial of Fulvestrant (Faslodex™) With or Without Concomitant Anastrozole (Arimidex™) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not yet known whether giving fulvestrant together with anastrozole is more effective than giving fulvestrant together with a placebo or exemestane alone in treating breast cancer.
PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how well they work compared to fulvestrant and a placebo or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Compare progression-free survival of postmenopausal women with estrogen receptor- and/or progesterone receptor-positive, locally advanced or metastatic breast cancer that relapsed or progressed during prior treatment with nonsteroidal aromatase inhibitors treated with fulvestrant with vs without anastrozole vs exemestane alone.
Secondary
- Compare the objective complete response (CR) and partial response (PR) rate and duration of response in patients treated with these regimens.
- Compare the clinical benefit (i.e., 6-month CR, PR, and stable disease) rate and duration of clinical benefit in patients treated with these regimens.
- Compare time to treatment failure in patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
OUTLINE: This is a randomized, partially double-blind and placebo-controlled, multicenter study. Patients are stratified according to the setting in which prior nonsteroidal aromatase-inhibitor therapy was given (adjuvant therapy vs first-line therapy) and participating center. Patients are randomized to 1 of 3 treatment arms.
- Arm I (fulvestrant and anastrozole): Patients receive fulvestrant intramuscularly (IM) on days 1, 15, and 29 and then once monthly. Patients receive oral anastrozole once daily.
- Arm II (fulvestrant and placebo): Patients receive fulvestrant as in arm I and oral placebo once daily.
- Arm III (exemestane alone): Patients receive oral exemestane once daily. In all arms, treatment repeats every month in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 750 patients (250 per treatment arm) will be accrued for this study.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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England
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London, England, 영국, SW3 6JJ
- Royal Marsden - London
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Sutton, England, 영국, SM2 5NG
- Institute of Cancer Research - Sutton
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast
- Locally advanced or metastatic disease
Metastatic disease must be measurable or evaluable
- Patients with bone only metastases are eligible provided there is an evaluable site of bone metastasis that can be followed by x-ray, MRI, or CT scan
Relapsed or progressed during prior treatment with single-agent nonsteroidal aromatase inhibitor (NSAI)*, meeting either of the following criteria:
- NSAI given as adjuvant therapy that lasted ≥ 12 months
Achieved an objective complete response, partial response, or stable disease that lasted ≥ 6 months after prior first-line therapy with NSAI for locally advanced or metastatic disease
- Chemotherapy as part of the first-line therapy given before initiation of NSAI allowed NOTE: *Patients are required to continue to take NSAI until beginning of study treatment.
- No rapidly progressive visceral disease (i.e., lymphangitis carcinomatosa or diffuse hepatic involvement)
Hormone receptor status:
- Estrogen receptor (ER) and/or progesterone receptor positive tumor
- No ER-unknown disease
PATIENT CHARACTERISTICS:
Sex
- Female
Menopausal status
Postmenopausal, as defined by 1 of the following criteria:
- Age 60 and over
- Age 45 to 59 AND ≥ 12 months since last menstrual period with no prior hysterectomy
- Any age with prior bilateral oophorectomy
Performance status
- WHO 0-2
Life expectancy
- More than 3 months
Hematopoietic
- Neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
- No thrombocytopenia
- Hemoglobin ≥ 10 g/dL
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN (unless due to bone metastases)
- No liver disease
Renal
- Creatinine < 1.97 mg/dL
Other
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Chemotherapy
- See Disease Characteristics
- Prior neoadjuvant or adjuvant chemotherapy allowed
Endocrine therapy
- See Disease Characteristics
- Prior tamoxifen as neoadjuvant or adjuvant therapy allowed
- No systemic corticosteroids that lasted > 15 days within the past 4 weeks
Other
- More than 4 weeks since prior investigational drugs
Concurrent bisphosphonates for bone metastases allowed provided bisphosphonate therapy has been established for ≥ 6 months
- Concurrent initiation of bisphosphonate allowed provided patient has soft tissue or visceral metastases as the measurable or evaluable target lesion
- No concurrent anticoagulant therapy
- No concurrent unlicensed noncancer investigational agents
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 마스킹: 더블
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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무진행 생존
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2차 결과 측정
결과 측정 |
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치료 실패까지의 시간
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전반적인 생존
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응답 기간
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내약성
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Duration of clinical benefit
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Objective complete response (CR) and partial response (PR) rate
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Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate
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공동 작업자 및 조사자
수사관
- 연구 의자: Stephen R. D. Johnston, MD, PhD, FRCP, Royal Marsden NHS Foundation Trust
간행물 및 유용한 링크
일반 간행물
- Fribbens C, O'Leary B, Kilburn L, Hrebien S, Garcia-Murillas I, Beaney M, Cristofanilli M, Andre F, Loi S, Loibl S, Jiang J, Bartlett CH, Koehler M, Dowsett M, Bliss JM, Johnston SR, Turner NC. Plasma ESR1 Mutations and the Treatment of Estrogen Receptor-Positive Advanced Breast Cancer. J Clin Oncol. 2016 Sep 1;34(25):2961-8. doi: 10.1200/JCO.2016.67.3061. Epub 2016 Jun 6.
- Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000448616
- ICR-CTSU-SOFEA
- EU-20531
- SSA-04Q200635
- ISRCTN44195747
- MREC-03677
- EUDRACT-2004-000093-30
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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