EUCTR2005-004001-29-CZ进行中（未招募）不适用
An Open Label, Randomised, Parallel Group, Multicentre Study toCompare ZOLADEX™ 10.8 mg Given Every 12 Weeks with ZOLADEX3.6 mg Given Every 4 Weeks in Pre-menopausal Women with OestrogenReceptor Positive Advanced Breast Cancer
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
- 260
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
- •Provision of written informed consent
- •- For the PK analyses in this study (see Section 4.5), optional additional blood
- •samples will be taken from those patients who provide written informed
- •consent to confirm that they are willing to participate in this part of the study.
- •This consent will be in addition to their written informed consent to confirm
- •their willingness to participate in the main study. See Section 8.3.1 for further
- •information
- •2. Female =18 years and pre-menopausal
- •- Pre-menopausal defined as 1) last menses within 1 year of administration of
- •study drug, and 2) E2 =10 pg/mL and FSH =30 mIU/mL within 4 weeks of
- •administration of study drug. For patients who have had a hysterectomy, it is
- •acceptable to meet only criterion 2.
- •3. Histological/cytological confirmation of locally advanced or metastatic breast
- •cancer and are candidates to receive hormonal therapy as therapy for advanced
- •disease. Patients may have received prior adjuvant chemotherapy, radiotherapy or
- •hormonal therapy for EBC
- •4. Documented evidence of hormone sensitivity (ER positive) of primary or secondary
- •tumour tissue
- •5. World Health Organization (WHO) Performance status of 0, 1 or 2 (see Appendix D)
- •6. At least one measurable lesion (not located in a previously irradiated area) according to RECIST with the exception of patients with bone metastases only or complete remission after prior taxane- or anthracycline based first line chemotherapy for ABC (stage IV). See Section 3.3.3, exclusion criterion 4, for further details of eligibility criteria concerning prior first line chemotherapy for ABC.
- •Patients with bone metastases only must fulfil one of the following conditions:
- •- Have osteolytic lesions identifiable by bone x-ray (patients with productive bone lesions only, as identified by bone x-ray, are not eligible),
- •- Have bone lesions identified by MRI or computed tomography scan (patients with productive bone lesions only, as identified by MRI or computed tomography scan, are eligible).
- •Patients with complete remission after prior taxane- or anthracycline based first line chemotherapy for ABC must fulfil one of the following conditions:
- •- Have had at least one measurable lesion (not located in a previously irradiated area) according to RECIST prior to taxane- or anthracycline based first line chemotherapy for ABC,
- •- Have had bone metastases meeting the criteria listed above prior to taxane- or anthracycline based first line chemotherapy for ABC.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who have received tamoxifen or other hormonal therapies as adjuvant
- •therapy for EBC in the 24 weeks before administration of study drug; prior treatment with hormonal therapies for ABC
- •2. Patients who have received LHRHa as adjuvant therapy for EBC in the 48 weeks
- •before administration of study drug (up to 2 years of adjuvant treatment with an
- •LHRHa is permitted)
- •3. Patients who have received any radiotherapy for EBC or ABC within 4 weeks before administration of study drug
- •4. Prior first line chemotherapy for ABC with the exception of taxane- or
- •anthracycline-based chemotherapy providing that a) there is no evidence of
- •progressive disease since the start of the chemotherapy and b) the patient has
- •pre-menopausal status after starting chemotherapy. Patients who have had prior
- •chemotherapy for ABC must have had at least one menstrual period since starting
- •chemotherapy. Any taxane- or anthracycline-based chemotherapy must be
- •completed at least 4 weeks prior to Day 1 of this study. (Prior adjuvant
- •chemotherapy for EBC is allowed except when it has been administered within 4 weeks before study drug administration )
- •5. Prior treatment with herceptin for EBC within 4 weeks before study drug administration; prior treatment with herceptin for ABC
- •6. Presence of life-threatening metastatic visceral disease, defined as extensive hepatic
- •involvement, or any degree (proven or suspected) of brain or leptomeningeal
- •involvement (past or present) or symptomatic pulmonary lymhangitic spread.
- •Patients with discrete pulmonary parenchymal metastases are eligible, provided
- •their respiratory function is not compromised as a result of disease
- •7. Estimated survival less than 24 weeks from the start of study therapy (Day 1) based on clinical judgment
- •8. History (within previous 3 years before administration of study drug) of systemic
- •malignancy other than breast cancer with the exception of basal cell/squamous cell
- •carcinoma of the skin or cancer of the cervix that has been satisfactorily controlled
- •9. Platelets <100x109/L; total bilirubin >1.5x upper limit of reference range (ULRR);
- •alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5xULRR if
- •no demonstrable liver metastases or >5xULRR in presence of liver metastases
- •10. Any other significantly abnormal laboratory test result at baseline that would place the patient at unusual risk or confound the results of the study as assessed by the treating investigator
- •11. Treatment with a non-approved or experimental drug within the preceding 12 weeks before administration of study drug
- •12. Patients with a relevant history of any severe concomitant disease that would place the patient at unusual risk or confound the results of the study (eg, a strong family history of osteoporosis or severe renal or hepatic impairment) as assessed by the treating investigator
- •13. Patients who, for whatever reason (eg, confusion, infirmity, alcoholism) are
- •unlikely to comply with study requirements as assessed by the treating investigator
- •14. Patients considered by the investigator to be at risk of transmitting any infection
- •through blood or other body fluids including the agents for acquired immune
- •deficiency syndrome or other sexually transmitted disease or hepatitis
- •15. History of bleeding diathesis (ie, disseminated intravascular coagulation or clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet
- •therapy and low dose warfarin)
- •16. History of any hypersensitivity to act
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