EUCTR2005-005715-22-DE进行中（未招募）不适用
A randomised Phase II Study comparing anastrozole and fulvestrant to anastrozole for adjuvant treatment of postmenopausal patients with early breast cancer and disseminated tumour cells in bone marrow - ABCSG 21
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 176
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: signed and dated Informed Consent Form prior to commencement of any specific protocol procedures
- •2.Histological confirmation (core needle biopsy or tumour excision) of breast can-cer staged (c/p)T1-4a-c N0-3 G1-3 M0
- •3.No signs of distant metastasis in
- •·Chest X-ray and liver ultrasound (OR chest and abdomen CT scan)
- •·Whole body bone scan
- •·Medical history and physical examination
- •·Routine laboratory evaluation as outlined in section 4.7.2
- •4.Documented positive hormone receptor status (ER +ve and/or PgR +ve) of par-affin-embedded primary tumour tissue (core needle biopsy or tumour excision), according to the local laboratory parameters. A positive hormone receptor status in fine needle aspiration may be used for pre-selection of patients for intraopera-tive Screening BM aspiration; a positive hormone receptor status of the tumour excision is required for inclusion in the study.
- •5.Postmenopausal woman, defined as a woman fulfilling any one of the following criteria:
- •·Age ³ 60 years;
- •·Amenorrhoea ³ 12 months with an intact uterus and = 1 intact ovaries;
- •·Having undergone a bilateral oophorectomy;
- •·For patients with at least one ovary but without a uterus, FSH and estradiol in the postmenopausal range;
- •·For patients previously treated with an LHRH antagonist, the last dose must have been 4 months prior to randomisation, menses must not have restarted and FSH and estradiol must be in the postmenopausal range;
- •·Patients who have received adjuvant or neoadjuvant chemotherapy must have met one of the above criteria for postmenopausal status prior to that chemotherapy (subgroup for which pregnancy testing might be considered).
- •6.WHO performance status 0, 1 or 2.
- •7.At Screening Phase (within 28 days prior to randomisation)
- •·Physical examination without clinically significant abnormalities
- •·Bone marrow aspiration with”DTC-positive” immunocytochemical result
- •·Chest X-ray, liver ultrasound, (or CT chest and abdomen) and bone scan without signs of metastatic breast cancer
- •·Laboratory requirements (at a clinically relevant time point prior to specific protocol procedures; i.e. for example 3-4 weeks after any preceding anti-tumour treatment, including chemotherapy, neoadjuvant Herceptin therapy):
- •oNeutrophils = 1.5 x 109/l, platelets = 100 x 109/l
- •oTotal bilirubin < 1 x ULN (except patients with confirmed Gilbert’s syn-drome who may be included in the study)
- •oAST (SGOT) and ALT (SGPT) < 1.5x ULN
- •oAlkaline phosphatases < 1 x ULN.
- •In case of abnormal values, the liver function tests have to be repeated and meet above criteria within 3 days before study treatment.
- •oCreatinine = 1.1 x ULN
- •8.At randomisation (endocrine treatment should start within the following 7 days)
- •·Final disease stage of completely resected pT1-4a-c N0-3 G1-3 M0 breast cancer
- •·Positive (ER +ve and/or PgR +ve) hormone receptor status of the formalin-fixed, paraffin-embedded tumour excision / mastectomy.
- •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.Inflammatory (pT4d) and / or metastatic breast cancer (M1)
- •2.Current or prior malignancy within previous 5 years (other than breast cancer or adequately treated non melanoma skin cancer or in-situ carcinoma of the cervix)
- •3.Premenopausal women
- •4. Planned adjuvant trastuzumab treatment, and preceding or concurrent systemic antitumour therapy; EXCEPT:
- •-Patient had received adjuvant chemotherapy and has a DTC-positive Screening Phase BM aspiration in local anaesthesia up to 8 weeks after but not less than 2 weeks of completion of chemotherapy;
- •-Patient had received prior neoadjuvant chemotherapy with or without trastuzumab with an incomplete response (e.g.PR, SD, PD) for assessment of hormone-receptor expression of the residual tumour and has a DTC-positive Screening Phase BM aspiration at or after definitive primary surgery up to 8 weeks after but not less than 2 weeks of completion of chemotherapy, and no continuation of trastuzumab treatment after surgery is planned;
- •5.Immunocytochemical BM screening: ”DTC-negative”
- •Note: patient is no longer subject of this trial and may enter other clinical trial
- •6.Treatment with a non-approved, investigational or experimental drug within 28 days before randomisation
- •7.History of bleeding diathesis (i.e., vW syndrome, disseminated intravascular co-agulation [DIC], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin with INR < 2 – see Sec-tion 3.7)
- •8.History of hypersensitivity to active or inactive excipients of fulvestrant, aroma-tase inhibitors or castor oil
- •9.Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial pro-tocol, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
- •10.Involvement in the planning and conduct of the study (applies to ABCSG staff, AstraZeneca staff or staff at the study site)
- •11.Previous enrolment or randomisation of treatment in the present study
研究者
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