EUCTR2007-007030-20-NL进行中（未招募）不适用
RANDOMIZED PHASE II/III STUDY OF SECOND-LINE ENDOCRINE TREATMENT FOLLOWED BY CAPECITABINE VERSUS CAPECITABINE FOLLOWED BY ENDOCRINE TREATMENT IN PATIENTS WITH METASTATIC ER POSITIVE BREAST CANCER - Capecitabine vs hormonal treatment
KI-AV0 个研究点开始时间: 2007年12月11日最近更新:
适应症
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
- •1.Written informed consent.
- •2.Proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease.
- •3.Positive estrogen receptor (= 10% positive nuclei at immunohistochemistry). Progesteron and HER-2 neu receptor have to be known.
- •4.- Progressive disease during first line hormonal therapy (either tamoxifen or aromatase inhibitor) for metastatic or inoperable locally advanced disease. Simultaneous use of LH-RH analogs is allowed.
- •- Recurrence of disease (M1) during adjuvant hormonal therapy (either tamoxifen or aromatase inhibitor).
- •5.Non-measurable M1 disease is accepted.
- •6.Performance status: WHO 0 - 2.
- •7.Adequate bone marrow function (WBC count > 3.0 x 109/l, platelets > 100 x 109/l).
- •8.Adequate hepatic function (ALAT, ASAT and bilirubine < 2 times the upper limit of normal; in case of liver metastases ALAT and ASAT should be less than 5 times the upper limit of normal).
- •9.Adequate renal function (serum creatinine< 1.5 upper limit of normal).
- •10.Willing and able to participate in Quality of Life investigation.
- •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.Prior chemotherapy for metastatic disease
- •2.Other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy.
- •3.Pregnancy or breast feeding must be excluded and patients must use adequate contraceptive protection.
- •4.Eligibly for any other ongoing clinical trial in the NKI-AVL (this study has ‘posteriority’).
- •5.Contra-indications to the use of capecitabine (at the discretion of the treating physician)
研究者
相似试验
已完成
2 期
RANDOMIZED PHASE II/III STUDY OF SECOND-LINE ENDOCRINE TREATMENT FOLLOWED BY CAPECITABINE VERSUS CAPECITABINE FOLLOWED BY ENDOCRINE TREATMENT IN PATIENTS WITH METASTATIC ER POSITIVE BREAST CANCERmammary neoplasms10006291breast cancerNL-OMON31795ederlands Kanker Instituut128
尚未招募
Unknown
A randomized phase II study of secondary cytoreductive surgery in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenanceKCT0008662Koera University Guro Hospital124
进行中（未招募）
1 期
A STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS PLACEBO PLUS PEMBROLIZUMAB IN PARTICIPANTS WITH IN PARTICIPANTS WITH MELANOMA THAT HAVE A GENETIC ABNORMALITY IN THE BRAF GENE.Metastatic or unresectable locally advanced BRAF V600E/K mutation positive melanomaMedDRA version: 20.0Level: HLTClassification code 10027156Term: Skin melanomas (excl ocular)System Organ Class: 100000004858MedDRA version: 21.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10066600Term: Melanoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027150Term: Melanoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027155Term: Melanoma skinSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10025665Term: Malignant melanoma of skin stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027152Term: Melanoma of skin (malignant)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA versiEUCTR2020-004850-31-HUPfizer Inc.624
进行中（未招募）
1 期
A STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS PLACEBO PLUS PEMBROLIZUMAB IN PARTICIPANTS WITH IN PARTICIPANTS WITH MELANOMA THAT HAVE A GENETIC ABNORMALITY IN THE BRAF GENE.Metastatic or unresectable locally advanced BRAF V600E/K mutation positive melanomaMedDRA version: 20.0Level: HLTClassification code 10027156Term: Skin melanomas (excl ocular)System Organ Class: 100000004858MedDRA version: 21.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10066600Term: Melanoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 27.0Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027150Term: Melanoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027155Term: Melanoma skinSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10025665Term: Malignant melanoma of skin stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027152Term: Melanoma of skin (malignant)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA versiEUCTR2020-004850-31-CZPfizer Inc.240
招募中
3 期
The STARBOARD Study: Phase 3 Study of Encorafenib and Binimetinib Plus Pembrolizumab in BRAF V600E/K Mutation-Positive Metastatic or Unresectable Locally Advanced Melanoma2024-512038-13-00Pfizer Inc.161