EUCTR2004-003617-16-AT进行中（未招募）不适用
A Randomized, Open-label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg with Fulvestrant (FASLODEX™) 250 mg when given as Neoadjuvant Treatment in Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0) - NEWEST – Neoadjuvant Endocrine therapy for Women with Estrogen Sensitive Tumors
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
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. Histologically/cytologically confirmed invasive breast cancer, ER positive as defined by the local laboratory
- •3. Operable or potentially operable locally advanced tumor (T2, 3, 4b, N0-3, M0). The largest diameter of the tumor as measured by ultrasound or by MRI must be ³ 2 cm. Patients with two measurable nodules will be eligible as long as both lesions are biopsied and have similar histology and are both ER positive.
- •4. Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria:
- •· Age ³ 60 years
- •· Age ³ 45 years with amenorrhea ³ 12 months with an intact uterus
- •· Having undergone a bilateral oophorectomy
- •· FSH and estradiol levels in postmenopausal range (utilizing ranges from the testing laboratory facility).
- •5. Willingness to undergo biopsy at baseline and at 4 weeks and surgery at 16 weeks
- •6. WHO performance status 0, 1 or 2
- •For inclusion in the genetic component of the study, patients must fulfill the following criteria:
- •1. Provision of informed consent for genetic sampling and analyses
- •If a patient declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Inoperable due to satellite skin nodules or true inflammatory carcinoma.
- •2. Multifocal disease (> 2 major tumor nodules). Patients with more than one primary tumor will be excluded.
- •3. Presence of metastatic disease as defined by the American Joint Committee on Cancer (AJCC) guidelines revised in 2002 (Singletary, 2002). Metastatic evaluation should be performed according to the usual guidelines of the institutions. It is recommended that the following evaluations should be done:
- •· Chest X-ray
- •· Liver function tests
- •· CBC with differential cell count and platelet count.
- •· Abdominal CT scan if liver function tests significantly elevated
- •· CT scan of the chest and abdomen for clinical stage ³ T3, or > N1
- •· Bone scan if bony discomfort, elevated serum alkaline phosphatase, ³ T3 or >N1 clinical disease
- •· Bilateral mammograms
- •4. Any previous treatment for breast cancer
- •5. Unwillingness to stop taking any drug known to affect sex hormonal status (including HRT), or a patient in whom it would be inappropriate to stop
- •6. Current or prior malignancy within previous 3 years (other than adequately treated basal cell or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix)
- •7. Any of the following laboratory values:
- •· Platelets < 100 ´ 109 / L
- •· Total bilirubin > 1.5 ´ ULRR
- •· ALT or AST > 2.5 ´ ULRR
- •8. Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the protocol, eg, uncontrolled cardiac disease or uncontrolled diabetes mellitus
- •9. Patients known to be HIV, hepatitis B or C positive are not eligible because of the potential to confound the study endpoints, although patients will not be routinely screened for HIV, hepatitis B or C
- •10. History of :
- •· bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or
- •· long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin – see Section 3.7)
- •11. History of hypersensitivity to castor oil
- •12. Treatment with a non-approved or experimental drug within 4 weeks before randomization
研究者
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