跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2007-002841-19-DE
EUCTR2007-002841-19-DE进行中（未招募）不适用

MULTICENTER, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BEVACIZUMAB IN COMBINATION WITH ENDOCRINE TREATMENT COMPARED TO ENDOCRINE TREATMENT ALONE, IN POSTMENOPAUSAL WOMEN WITH ADVANCED OR METASTATIC CANCER WITH INDICATION OF HORMONOTHERAPY AS FIRST-LINE TREATMENT

Grupo Español de Investigación en Cáncer de Mama (GEICAM)0 个研究点目标入组 378 人开始时间: 2008年4月16日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
相关药物

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
378
研究概览入排标准研究者记录与标识符相似试验

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 Before starting the specific protocol procedures, the written informed consent must be obtained and documented.
  • •2. Women = 18 years.
  • •3. Capacity to comply with all the protocol requirements.
  • •4. Functional ECOG status of 0 or 1.
  • •5. Life expectancy = 24 weeks.
  • •6. Postmenopausal women with histologically confirmed breast adenocarcinoma, with measurable or non-measurable, locally advanced or metastatic (stage IV) disease. In the event that the patient only has locally advanced disease, she will not be able to undergo curative local treatment. Patients with metastasis confined to the bone can be chosen, but the disease must be confirmed by radiology, CT scan or NMR if there is any doubt after a single bone scan.
  • •7. Patients with HER2-negative disease evaluated by IHC and FISH/CISH (IHC 0 or 1+, or 2+ and negative FISH). Patients with 3+ by IHC cannot be chosen regardless of the FISH/CISH status and those with positive FISH/CISH (> 2 amplifications) cannot be chosen either, regardless of the IHC findings.
  • •8. Positive hormone receptors (estrogen receptor [ER] and/or progesterone receptor [PgR]) evaluated by a local or central laboratory, according to the criteria of the participating institution.
  • •9. Patients who are candidates for receiving first-line treatment with letrozole.
  • •10. Patients may have received (neo)adjuvant chemotherapy, provided that the last dose of the latter was received at least 12 months before randomization . Patients must have recovered from toxicity.
  • •11. The patients are allowed to have received adjuvant radiotherapy, provided that it was completed at least 6 weeks before randomization and the patient has recovered from the reversible acute effects of the radiation. The previous administration of radiotherapy to palliate the pain of bone metastases is authorized, provided that:
  • •a. Not more than 30% of bone marrow has been irradiated.
  • •b. The patient has recovered from the reversible acute effects of the radiation.
  • •c. The patient has at least one metastatic location which has not been irradiated and which may be evaluated for progression, or a clear progression of the bone disease has been objectified after the end of the palliative radiotherapy.
  • •12. The patients may have received previous (neo)adjuvant hormonotherapy provided that they are considered to be candidates to first-line hormonotherapy with letrozole. They may also have received previous adjuvant treatment with an aromatase inhibitor provided that it ended at least 12 months before randomization.
  • •13. The treatment with bisphosphonates is allowed and recommended for patients with bone metastases. Whenever it is possible, the treatment should be started before or within the 4 weeks of starting the study therapy. The patients starting treatment with bisphosphonates must be carefully evaluated so that they do not mask the progression of the disease.
  • •14. In the patients with heart failure risk (e.g. previously treated with > 360mg/m2 of doxorubicin or equivalent doses of other anthracyclines), the LVEF must be determined by means of an echocardiogram or radionuclide ventriculography (MUGA), and it must t be > the lower limit of normal.
  • •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. Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator’s judgment.
  • •2. Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.
  • •3. Patient in treatment with anticoagulant therapy.
  • •4. Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjunvant hormonotherapy the same premises than for the adjunvant hormonotherapy are valid.
  • •5. Previous therapy with anti-VEGF or VEGFR tyrosine-kinase inhibitors.
  • •6. History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.
  • •7. Evidence of CNS metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.
  • •8. History of peripheral neurophaty NCI CTCAE grade >2 at the time of randomization.
  • •9. Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.
  • •10. Minor surgical procedures in the 7 days prior to randomization.
  • •11. Unsuitable bone marrow supply: ANC < 1.5 x 109/L, platelets < 100 x 109/L or Hb < 10 g/dL.
  • •12. Impaired liver function: total bilirubin total > 1.5 x ULN, AST and ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases).
  • •13. Impaired kidney function:
  • •a. Serum creatinine > 2.0 mg/dL or 177 µmol/L.
  • •b. Proteinuria determined by reactive strip > 2+. A 24h determination of proteins in urine will be requested for the patients with > 2+ in the baseline analysis and must have a protein figure > 1 g/24 h.
  • •14. Chronic treatment with oral corticoids (dose > 10 mg/day of methylprednisolone or equivalent): the use of inhaled corticoids is allowed.
  • •15. Chronic Treatment with heparin and oral anticoagulants (coumarin derivates)
  • •16. Chronic treatment with acetylsalicylic acid (> 325 mg/day) or clopidogrel (> 75 mg/day).
  • •17. Uncontrolled arterial hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant cardiovascular disease: for example CVA (in the 6 months prior to randomization), coronaropathy or history of AMI in the last 6 months, unstable angina, congestive heart failure of grade > II of the New York Heart Association (NYHA) or severe heart arrhythmias which are not controlled with medication or which can potentially interfere with the study treatment.
  • •18. History or evidence of hemorrhagic diathesis or coagulopathy with bleeding risk.
  • •19. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abcess in the 6 months prior to randomization.
  • •20. Active infection requiring i.v. antibiotics at the time of randomization.
  • •21. Unhealed wounds, active peptic ulcer, esophageal varices.
  • •22. Any other disease, psychological or metabolic alteration, found in the physical or laboratory examination, providing reasonable indications for suspecting a disease or complaint for

研究者

发起方
Grupo Español de Investigación en Cáncer de Mama (GEICAM)

相似试验

进行中（未招募）
1 期
STUDY TO OPTIMIZE IMMUNOSUPPRESSIVE MEDICATION AS A RESULT OF TWO MARKERS IN PATIENTS WHO RECEIVE A RENAL TRANSPLANTATION OF A LIVE DONORPROPHYLAXIS OF REJECTION AFTER KIDNEY TRANSPLANTATIONMedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disorders
EUCTR2017-002293-39-NLORIOL BESTARD164
进行中（未招募）
1 期
STUDY TO OPTIMIZE IMMUNOSUPPRESSIVE MEDICATION AS A RESULT OF TWO MARKERS IN PATIENTS WHO RECEIVE A RENAL TRANSPLANTATION OF A LIVE DONOR
EUCTR2017-002293-39-ESORIOL BESTARD
尚未招募
不适用
Multicenter randamized study for evaluating the effect of dantrolene aganst heart failure and arrhythmiaheart failure
JPRN-UMIN000022756Yamaguchi University Graduate School of Medicine100
进行中（未招募）
不适用
A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy StudyMultiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK.
EUCTR2005-005751-18-GBCL Biomedicine R&D Unit100
进行中（未招募）
1 期
Study of the efficacy of early intervention with secukinumab 300 mg s.c. compared to narrow-band UVB in patients with new-onset moderate to severe plaque psoriasisPlaque psoriasisMedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858
EUCTR2015-002423-26-EEovartis Pharma Services AG196