EUCTR2013-001629-23-IT进行中（未招募）不适用
A phase III study comparing the concurrent versus the sequential administration of chemotherapy and aromatase inhibitors, as adjuvant treatment of post-menopausal patients with endocrine-responsive early breast cancer. - GIM10-CONSENT
IRCCS AOU SAN MARTINO- IST0 个研究点开始时间: 2013年6月17日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Women with histological diagnosis of invasive breast cancer completely removed by surgery, any T, any N.
- •- Postmenopausal status defined by at least one of the following conditions:
- •1. Aged = 60
- •2. Aged 45-59 and satisfying one or more of the following criteria
- •amenorrhea for =12 months and intact uterus;
- •amenorrhea for <12 months and FSH within the
- •postmenopausal range, including:
- •?? pts with hysterectomy
- •?? pts who have received HRT
- •?? pts with chemotherapy-induced amenorrhea
- •3. bilateral oophorectomy at any age >18 years.
- •- Primary tumor positive for ER and/or PgR (=1% tumor cells positive by
- •immunohistochemistry or = 10 fmol/mg cytosol protein by ligand binding assay).
- •- Patients who are prescribed 5 years of endocrine therapy with an AI
- •- Indication for adjuvant chemotherapy- Patients with HER-2 positive tumors are eligible provided that they are prescribed
- •trastuzumab according to registered schedule.
- •- Signed informed 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 1200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •- HRT currently assumed or during the month before randomization
- •- Recurrent or metastatic disease
- •- HER-2 positive tumors if treatment with trastuzumab is considered not appropriate/feasible
- •- Concurrent illness that contraindicate adjuvant endocrine treatment and/or chemotherapy
- •- Patients who have received TAM as part of any breast cancer prevention trial
- •- Previous history of invasive breast cancer or other invasive malignancy within
- •the previous 10 years, other than squamous or basal cell carcinoma of the skin
- •or carcinoma in situ of the cervix, adequately cone biopsied
- •- Concomitant severe disease which would place the patient at unusual risk
- •- Concurrent treatment with experimental drugs
- •- Patients treated with systemic investigational drugs within the past 30 days
研究者
相似试验
进行中（未招募）
1 期
A Randomised Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma - FEDEGYN 01/0902 - PORTEC 3Patientes atteintes d’un cancer de l’endomètre de stade avancé et à haut risque de récidive, initialement traitées par chirurgie. Carcinome de l’endomètre de stade IB grade 3 +LVSI (invasion de l’espace lympho-vasculaire), IC ou IIA grade 3, IIB, IIIA ou IIIC (les IIIA basés uniquement sur la cytologie péritonéale sont éligibles seulement si grade 3), et IB, IC, II ou III avec histologie des cellules séreuses ou claires.MedDRA version: 9.1 Level: LLT Classification code 10014738 Term: Endometrial cancer stage IMedDRA version: 9.1 Level: LLT Classification code 10014739 Term: Endometrial cancer stage IIMedDRA version: 9.1 Level: LLT Classification code 10014740 Term: Endometrial cancer stage IIIEUCTR2007-004917-33-FReiden University Medical Centre500
进行中（未招募）
不适用
A III Trial Comparing Chemotherapy and Radiotherapy against Radiotherapy alone in patients with High Risk and Advanced Uterus cancer.Endometrial carcinomaMedDRA version: 14.1Level: PTClassification code 10014740Term: Endometrial cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10014739Term: Endometrial cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10014738Term: Endometrial cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-004917-33-GBeiden University Medical Centre670
进行中（未招募）
1 期
A phase II study evaluating the use of concurrent cetuximab, irinotecan, oxaliplatin and UFT in the first line treatment of patients with metastatic colorectal cancer - e-SCOUTAdvanced, inoperable or metastatic colorectal cancer.EUCTR2007-002053-24-GBThe Christie NHS Foundation Trust
已完成
3 期
Trial comparing the effectiveness of daily radiation therapy plus a second daily radiation boost dose with daily radiation therapy plus three-weekly chemotherapy in advanced cancers of the head and neck.CTRI/2018/03/012579Bodhisattwa Dutta96
进行中（未招募）
不适用
A Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma - PORTEC-3EUCTR2007-004917-33-ATeiden University Medical Centre800