EUCTR2005-002868-28-ES进行中（未招募）1 期
Ensayo fase II aleatorizado, abierto, de grupos paralelos, multicéntrico para comparar la eficacia y tolerabilidad de fulvestrant (FASLODEX®) 500 mg con anastrozol (ARIMIDEX®) 1 mg en el tratamiento hormonal de primera línea de mujeres posmenopáusicas con cáncer de mama avanzado y receptores hormonales positivos. - FIRST
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •2.Histological/cytological confirmation of breast cancer
- •3.Documented positive hormone receptor status (ER +ve and/or PgR + ve) of primary or metastatic tumour tissue, according to the local laboratory parameters
- •4.Patients with metastatic or locally advanced disease not amenable to therapy with curative intent:
- •(a)who have never had hormonal therapy for locoregionally advanced or metastatic disease
- •(b)For patients who have received previous adjuvant or neoadjuvant hormonal treatment, this must have been completed more than 12 months prior to randomisation.
- •5.Patients fulfilling one of the following criteria:
- •·Patients with measurable disease as per RECIST criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques or as = 10 mm with spiral CT scan
- •·Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria. Bone lesions must be evaluable by plain X-ray, CT or MRI. Patients with lesions identified only on radionucleotide bone scan are not eligible
- •6. Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria:
- •·Age = 60 years
- •·Age = 45 years with amenorrhoea = 12 months with an intact uterus
- •·Having undergone a bilateral oophorectomy
- •·FSH and oestradiol levels in postmenopausal range (utilising ranges from the local laboratory facility)*
- •* In patients who have previously been treated with an LH-RH analogue, the last depot must have been administered more than 4 months prior to randomisation and menses must not have restarted.
- •7.WHO 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
- •1.Provision of written informed consent
- •2.Histological/cytological confirmation of breast cancer
- •3.Documented positive hormone receptor status (ER +ve and/or PgR + ve) of primary or metastatic tumour tissue, according to the local laboratory parameters
- •4.Patients with metastatic or locally advanced disease not amenable to therapy with curative intent:
- •(a)who have never had hormonal therapy for locoregionally advanced or metastatic disease
- •(b)For patients who have received previous adjuvant or neoadjuvant hormonal treatment, this must have been completed more than 12 months prior to randomisation.
- •5.Patients fulfilling one of the following criteria:
- •·Patients with measurable disease as per RECIST criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques or as = 10 mm with spiral CT scan
- •·Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria. Bone lesions must be evaluable by plain X-ray, CT or MRI. Patients with lesions identified only on radionucleotide bone scan are not eligible
- •6. Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria:
- •·Age = 60 years
- •·Age = 45 years with amenorrhoea = 12 months with an intact uterus
- •·Having undergone a bilateral oophorectomy
- •·FSH and oestradiol levels in postmenopausal range (utilising ranges from the local laboratory facility)*
- •* In patients who have previously been treated with an LH-RH analogue, the last depot must have been administered more than 4 months prior to randomisation and menses must not have restarted.
- •7.WHO 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
- •1.Provision of written informed consent
- •2.Histological/cytological confirmation of breast cancer
- •3.Documented positive hormone receptor status (ER +ve and/or PgR + ve) of primary or metastatic tumour tissue, according to the local laboratory parameters
- •4.Patients with metastatic or locally advanced disease not amenable to therapy with curative intent:
- •(a)who have never had hormonal therapy for locoregionally advanced or metastatic disease
- •(b)For patients who have received previous adjuvant or neoadjuvant hormonal treatment, this must have been completed more than 12 months prior to randomisation.
- 另有 16 项未显示
排除标准
- •1.Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not significantly compromised as a result of disease
- •2.Previous systemic therapy for advanced breast cancer.
- •3.Treatment with a non-approved or experimental drug within 4 weeks before randomisation
- •4.Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix)
- •5.Any of the following laboratory values within 3 weeks of randomisation:
- •·Platelets < 100 x 10 to the power of 9 / L
- •·Total bilirubin > 1.5 x ULRR**
- •** Patients with confirmed Gilbert’s syndrome may be included in the study
- •·ALT or AST > 2.5 x ULRR if no demonstrable liver metastases or > 5 x ULRR in presence of liver metastases
- •6.History of :
- •·bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or
- •·long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin )
- •7.History of hypersensitivity to active or inactive excipients of fulvestrant, aromatase inhibitors or castor oil
- •8.Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol. e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus.
- •1.Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not significantly compromised as a result of disease
- •2.Previous systemic therapy for advanced breast cancer.
- •3.Treatment with a non-approved or experimental drug within 4 weeks before randomisation
- •4.Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix)
- •5.Any of the following laboratory values within 3 weeks of randomisation:
- •·Platelets < 100 x 10 to the power of 9 / L
- •·Total bilirubin > 1.5 x ULRR**
- •** Patients with confirmed Gilbert’s syndrome may be included in the study
- •·ALT or AST > 2.5 x ULRR if no demonstrable liver metastases or > 5 x ULRR in presence of liver metastases
- •6.History of :
- •·bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or
- •·long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin )
- •7.History of hypersensitivity to active or inactive excipients of fulvestrant, aromatase inhibitors or castor oil
- •8.Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol. e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus.
- •1.Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not significantly compromised as a result of disease
- •2.Previous systemic therapy for advanced breast cancer.
- •3.Treatment with a non-approved or experimental drug within 4 weeks before randomisation
- •4.Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix)
- •5.Any of the following laboratory values within 3 weeks of randomisation:
- •·Platelets < 100 x 10 to the power of 9 / L
- •·Total bilirubin > 1.5 x ULRR**
- •** Patients with confirmed Gilbert’s syndrome may be included in the study
- •·ALT or AST > 2.5 x ULRR if no demonstrable liver metastases or > 5 x ULRR in presence of liver metastases
- •6.History of :
- •·bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or
- •·long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin )
- •7.History of hypersensitivity to active or inactive excipients of fulvestrant, aromatase inhibitors or castor oil
- •8.Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol. e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus.
研究者
相似试验
进行中（未招募）
1 期
Ensayo de faseII, abierto, aleatorizado para evaluar la eficacia y seguridad de AZD6244 versus capecitabina (XelodaTM) en pacientes con cáncer colorrectal que han fracasado a una o dos líneas previas de quimioterapia.Cáncer colorrectal metastáticoEUCTR2006-001457-10-ESAstraZeneca AB64
进行中（未招募）
1 期
Estudio de fase 2b, abierto, aleatorizado, de grupos paralelos y multicéntrico para evaluar la seguridad, tolerabilidad e inmunogenicidad de la vacuna recombinante contra el meningococo del grupo B de Novartis, administrada con o sin vacunaciones infantiles sistemáticas a niños sanos de acuerdo con diferentes esquemas de inmunización.A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered with or without Routine Infant Vaccinations to Healthy Infants According to Different Immunization SchedulesEUCTR2008-001592-30-ESovartis Vaccines and Diagnostics S.r.l.1,885
进行中（未招募）
1 期
Estudio fase II abierto, aleatorizado, de dos grupos paralelos y comparativo de BMS-690514 + letrozol frente a lapatinib + letrozol en pacientes con cáncer de mama en recaída o metastásico con receptores hormonales positivos independientemente de la positividad del receptor HER2 y que han recaído durante o después de terminar un tratamiento adyuvante antiendocrinoProtocolo Revisado 01, que incorpora la enmienda 02+ Enmienda de Farmacogenética Número 01 - Específica de Centro (versión 1.0 de fecha 20-Nov-09)Cáncer de mama con receptores hormonales positivos (RH+), localmente recidivante o metastásico y:- Enfermedad HER2+ con progresión mientras reciben tratamiento antiendocrino adyuvante o en cualquier momento después del tratamiento antiendocrino adyuvante o- Enfermedad HER2- con progresión mientras reciben tratamiento antiendocrino adyuvante o en el plazo de 6 meses después de terminar el tratamiento antiendocrino adyuvante.MedDRA version: 12.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2009-016622-13-ESBristol-Myers Squibb International Corporation175
进行中（未招募）
不适用
Estudio de fase II, aleatorizado, abierto (con grupos de control enmascarados de activador del plasminógeno y placebo) para evaluar los efectos de distintos regímenes de infusión intratrombo de plasmina (humana) en comparación con activador del plasminógeno y placebo en pacientes con oclusión aguda de una arteria nativa de las extremidades inferiores o de un injerto de derivacióEUCTR2010-019760-36-ESTalecris Biotherapeutics, Incorporated100
进行中（未招募）
1 期
Estudio en fase 1/2, abierto y aleatorizado de la seguridad, eficacia y farmacocinética de letrozol más PD 0332991 (inhibidor oral de CDK 4/6) y letrozol en monoterapia, para el tratamiento en primera línea del cáncer de mama avanzado RE-positivo y Her2-negativo en mujeres posmenopáusicasPHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991 (ORAL CDK 4/6 INHIBITOR) AND LETROZOLE SINGLE AGENT FOR THE FIRST-LINE TREATMENT OF ER POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN - n/aCancer de Mama avanzado Advanced Breast CancerMedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2008-002392-27-ESPFIZER150