EUCTR2006-000320-14-IS进行中（未招募）不适用
Anastrozole monotherapy versus maximal oestrogen blockage with anastrozole and fulvestrant comination therapy: An open, randomised, comparative, phase III multicentre study in postmenopausal women with hormone receptor positive breast cancer in first relapse after primary treatment of localised tumour. - FACT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 512
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Provision of written informed consent
- •2. Postmenopausal female subjects with relapses after primary treatment of localised breast cancer. Postmenopausal women defined as:· Women aged 50 years or over who have not menstruated during 6 months, or who have FSH levels within the post-menopausal range.· Women under the age of 50 years who have not menstruated during 12 months, and who have FSH levels within the post-menopausal range.· Postmenopausal status induced by goserelin 3.6 mg, initiated in the adjuvant setting and not as a treatment for recurrent disease. Treatment with LHRHanalogue must be continued throughout the study period.
- •3. Histological or cytological confirmed cancer of the breast with locally recurrent
- •disease, which is unsuitable for local treatment, or metastatic breast cancer. Time
- •interval from primary surgery to the recurrence/ metastases must be > 8 weeks. It is
- •recommended that recurrences or metastases are confirmed morphologically,
- •particularly in case of solitary lesions. Subjects are to be candidates to receive endocrine therapy as their first line systemic treatment for recurrent disease.
- •Patients who relapse after or while on adjuvant endocrine treatment with tamoxifen
- •may be included in the study provided they have a recurrence-free interval, I e from
- •start of their adjuvant tamoxifen until relapse, of more than 12 months.
- •Patient who relapse while on or after adjuvant cytotoxic chemotherapy may be
- •included in the trial Patient who relapse after adjuvant therapy with an aromatase inhibitor may be included in the trial provided there is an interval of more than 12 months since stopping this therapy and entry into the current study.
- •4. Breast cancer must be documented oestrogene and/or PgR positive. Hormone receptor positivity is defined accordingly to routines at each participating laboratory. Cut-off level for positivity shall be predefined for each participating centre. If analyses are done using a quantitative method, a cut-off level for receptor positivety of > 0.05 fmoler/microg. DNA, or > 10 fmol/mg protein is recommended. If analyses are based on immunohistochemistry a cut-off level of > 10% positive tumour cells is
- •recommended. The receptor determinations should be based on assays of the primary tumor. If such data are unavailable results of receptor analyse of the recurrence may be used instead.Page 25 of 25
- •5. The breast cancer can be a measurable or non-measurable disease. Chest x-ray and any x-rays and scans for assessment of measurable disease must be performed within 28 days prior to randomisation. Non-measurable disease must be assessed within 42 days prior to randomisation.
- •Measurable disease: Lesion that can be accurately measured in at least one dimension by 1)medical photograph (skin or oral lesion), palpation, plain x-ray, CT, MRI or other techniquewith longest diameter 2 cm or greater in the axial plane (bone lesions not included), or 2)spiral CT with longest diameter 1 cm or greater. Ultrasound is suitable only for superficial disease (superficial palpable nodes, subcutaneous lesions, thyroid nodules).
- •Non-measurable disease: Lesions considered to be truly nonmeasurable include the following:bone lesions, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis,cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques and cystic lesions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (1
排除标准
- •1. Previous systemic endocrine therapy for advanced or recurrent breast cancer.
- •2. Any prior fulvestrant therapy.
- •3. Premenopausal women.
- •4. Subjects with known CNS metastases or subjects with only sclerotic bone lesions.
- •5. Other malignant disease during the past 5 years, except adequately treated and
- •cured carcinoma in situ cervix uteri or basal cell carcinoma of the skin. Patients
- •with a diagnosis of malignant disease >5 years ago can be included provided there
- •is no signs or symtoms of the disease and there is unequivocal evidence that the
- •current disease represents locally recurrent or metastatic, hormone receptor positive
- •breast cancer.
- •6. Subjects not eligible for endocrine treatment for any reason.
- •7. Currently receiving (and are unwilling to discontinue) oestrogen replacement
- •8. Subjects who have another significant medical or surgical condition, or who require
- •any other medication, which may interfere with the evaluation of safety and
- •efficacy of the study treatment. Evidence of severe or uncontrolled systemic disease
- •(e.g., severe renal or hepatic impairment) or currently unstable or uncompensated
- •respiratory or cardiac condition at the discretion of the investigator; risk (in the
- •investigator’s opinion) of transmitting human immunodeficiency virus, hepatitis B
- •or C, through blood or other bodily fluids.
- •9. Estimated survival less than three months from the start of study therapy based on clinical judgment.
- •10. Laboratory results sustained at:
- •- platelets <100 x 109/l
- •- prothrombin time (PT) reported as the INR > 1.6
- •- total bilirubin > 1,5 x ULN
- •- ALT or AST > 2,5 x ULN if no demonstrable liver disease or > 5 x ULN in
- •presence of liver metastases
- •No more than three retests within screening period
- •11. Subjects who have received any investigational drug/non-approved drug within four weeks of study entry.
- •12. Subjects who, for whatever reason (e.g. confusion, infirmity, alcohol abuse) are
- •unlikely to comply with study requirements.
- •13. History of hypersensitivity to active or inactive excipients of fulvestrant or
- •anastrozole.
- •14. Subjects who are on chronic anticoagulant therapy, except for the maintenance of an indwelling venous catheter. This does not include treatment with low-dose
- •aspirin which is allowed
研究者
相似试验
进行中（未招募）
1 期
Anastrozole monotherapy versus maximal oestrogen blockage with anastrozole and fulvestrant comination therapy: An open, randomised, comparative, phase III multicentre study in postmenopausal women with hormone receptor positive breast cancer in first relapse after primary treatment of localised tumour. - FACTEUCTR2006-000320-14-FRAstraZeneca AB512
进行中（未招募）
1 期
Anastrozole monotherapy versus maximal oestrogen blockage with anastrozole and fulvestrant comination therapy: An open, randomised, comparative, phase III multicentre study in postmenopausal women with hormone receptor positive breast cancer in first relapse after primary treatment of localised tumour. - FACTHormone receptor positive breast cancer in first relapse after primary treatment of localised tumour, in postmenopausal women.EUCTR2006-000320-14-FIAstraZeneca oy512
进行中（未招募）
不适用
Anastrozole monotherapy versus maximal oestrogen blockage with anastrozole and fulvestrant combination therapy: An open, randomised, comparative, phase III multicentre study in postmenopausal women with hormone receptor positive breast cancer in first relapse after primary treatment of localised tumour. - FACTHormone receptor positive breast cancer in first relapse after primary treatment of localised tumour, in postmenopausal women.EUCTR2006-000320-14-PTAstraZeneca Produtos Farmacêuticos Lda512
进行中（未招募）
不适用
FACT anastrozole monotherapy versus maximal oestrogen blockade with anstrozole and fulvestrant combination therapy an open randomized, comparative, phase III multicentre study in postmenopausal women with hormone receptor positive breast cancer in first relapse after primary treatment of localized tumour. - FACTHormone Receptor Positive Advanced Breast CancerMedDRA version: 6.1Level: PTClassification code 10057654EUCTR2006-000320-14-ITASTRAZENECA512
已完成
3 期
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination TherapyBreast CancerNCT00256698AstraZeneca514