EUCTR2006-000436-27-GB进行中（未招募）不适用
eoadjuvant trial of pre-operative exemestane or letrozole +/-celecoxib in the treatment of ER positive postmenopausal early breast cancer. - NEO-EXCE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 256
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
- •The study population consists of postmenopausal women diagnosed with resectable breast cancer, who meet the following eligibility criteria:
- •-Biopsy proven, ER positive invasive breast cancer (where ER positive is defined as equivalent to an ER Quick or Allred score” of 3 or greater).
- •-Tumour, measured on ultrasound, as greater than or equal to 2 cm in diameter.
- •-Postmenopausal defined as:
- •Any Age:- bilateral surgical oophorectomy
- •amenorrhea ? 5 years (any cause)
- •Age ? 50 yrs:-natural amenorrhea for ? 1 year
- •Age <50 yrs: -if amenorrhea < 5 years or hysterectomy without
- •bilateral surgical oophorectomy, then FSH, and/or LH and/or
- •oestradiol must be assayed to confirm postmenospausal status
- •-Adequate haematological, renal and liver function, defined as a platelets of >100 x 109/l, white blood cell count of >3 x 109/l, creatinine <110 mmol/l, AST and/or ALT < 1.25 x upper limit of normal
- •-Patients must be fit to complete surgery for their breast cancer
- •-Written informed consent
- •- ECOG performance status 0,1 or 2
- •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
- •-Bilateral breast cancer.
- •-Evidence of distant metastases (M1).
- •-Patients who have received previous treatment for invasive breast cancer.
- •-Concomitant active malignancy.
- •-Co-morbid disease which would preclude safe surgical treatment of the primary cancer.
- •- Other physical or psychiatric disorder that may interfere with subject compliance, adequate informed consent or determine the causality of adverse events.
- •- Contraindications to celecoxib: active peptic ulcer disease, renal impairment, asthma exacerbated by NSAIDS, congestive cardiac failure (NYHAII-IV*), ischaemic heart disease, cerebrovascular disease, uncontrolled hypertension.
- •-Patients with an ongoing requirement for regular NSAID or COX2 inhibitor therapy (Asprin 75mg daily is permitted).
- •-Regular selective COX 2 inhibitor use in the 2 years prior to randomisation
- •-History of hypersensitivity to celecoxib, exemestane or letrozole or to any of the excipients (see section 6.1).
- •-Known hypersensitivity to sulphonamides.
- •-Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 inhibitors.
- •-Inflammatory bowel disease.
- •-Patients with ongoing requirements for fluconazole or ketoconazole therapy.
- •-Patients with ongoing requirement for lithium therapy.
- •-Patients with ongoing requirement for ACE inhibitor therapy.
- •-Patients who are on warfarin or heparin .
研究者
相似试验
已完成
3 期
eoadjuvant trial of pre-operative exemestane or letrozole +/- celecoxib in the treatment of oestrogen receptor-positive early breast cancerEarly breast cancerBreast cancerCancerISRCTN09768535niversity Hospital Birmingham NHS Foundation Trust (UK)269
招募中
2 期
Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-23)Breast cancerJPRN-UMIN000006453PO Saitama Breast Cancer Clinical Study Group (SBCCSG)60
已完成
2 期
Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-10)JPRN-UMIN000000802Saitama Breast Cancer Clinical Study Group (SBCCSG)23
进行中（未招募）
1 期
Phase II study of pre-operative treatment with external radiotherapy plus panitumumab in operable locally advanced rectal cancer (favourable and intermediate prognostic group) (RaP Study/STAR-03)Operable locally advanced rectal cancerMedDRA version: 14.1Level: LLTClassification code 10038019Term: Rectal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000649-20-ITFONDAZIONE DELL'ISTITUTO TOSCANO TUMORI92
已完成
3 期
Phase III Randomized Adjuvant Study of Exemestane Versus Anastrozole Versus Tamoxifen in Hormone-Responsive Postmenopausal Breast Cancer PatientsJPRN-C000000057-SAS BC 04 executive committee300