EUCTR2012-005326-29-IT进行中（未招募）1 期
A randomized phase II trial evaluating the endocrine activity and efficacy of neoadjuvant degarelix versus triptorelin in premenopausal patients receiving letrozole for locally advanced endocrine responsive breast cancer - TREND (TRial on the Endocrine activity of Neoadjuvant Degarelix)
International Breast Cancer Study Group (IBCSG)0 个研究点目标入组 51 人开始时间: 2013年9月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 51
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
- •Female gender
- •Premenopausal status determined locally:
- •-Estradiol (E2) above 54 pg/mL (or above 198 pmol/l),measured
- •=14 days prior to randomization
- •-If estradiol (E2) is =54 pg/mL, but the patient cannot be
- •regarded as postmenopausal, estradiol testing should be
- •repeated to confirm eligibility
- •Age = 18 years
- •Eastern Cooperative Oncology Group Performance Status
- •(ECOG PS) of 0 or1.
- •Histologically confirmed invasive breast cancer:
- •-Primary tumor greater than 2 cm diameter, measured by clinical
- •examination and mammography or echography (cT2-4b)
- •-No evidence of metastasis (M0)
- •Primary tumor must have ER and PgR >50% of the cells
- •Primary tumor must be HER2 negative or not amplified
- •Hematopoietic status:
- •-Absolute neutrophil count = 1.5 × 109/L,
- •-Platelet count = 100 × 109/L,
- •-Hemoglobin = 9 g/dL
- •Hepatic status:
- •-Serum total bilirubin = 1.5 × upper limit of normal (ULN). In the
- •case of known Gilbert’s syndrome, a higher serum total bilirubin
- •(< 2 × ULN) is allowed
- •-AST and ALT = 2.5 × ULN
- •-Alkaline phosphatase = 2.5 × ULN
- •Renal status: Creatinine = 1.5 × ULN
- •Negative serum pregnancy test, within 2-weeks (preferably 7
- •days) prior to randomization. Pregnancy test has to be repeated
- •before treatment start if treatment does not start within 15
- •days of the previous test.
- •The patient must be willing to use effective non-hormonal
- •contraception (barrier method – condoms, diaphragm – also in
- •conjunction with spermicidal jelly, or total abstinence) after the
- •pregnancy test and up to surgery. Oral, injectable, or implant
- •hormonal contraceptives or medicated IUD are not allowed.
- •Prior fertility treatment is allowed but must have been stopped at
- •least 12 months before randomization
- •The patient has completed the baseline patient-reported
- •symptoms questionnaire
- •Written Informed Consent (IC) must be signed and dated by the
- •patient and the Investigator prior to randomization
- •The patient has been informed of and agrees to data transfer
- •and handling, in accordance with national data protection
- •The patient accepts blood samples to be taken according to the
- •schedule in section 4.1 for the determination of the primary
- •The patient accepts to make tumor (biopsy and surgical
- •specimen) available for submission for central pathology review
- •and to conduct translational studies as part of this protocol
- •Are the trial subjects under 18? no
- 另有 5 项未显示
排除标准
- •Postmenopausal patients.
- •Any hormonal treatment (either oral, injectable, implant, or
- •medicated IUD) in the previous 2 months.
- •Presence of HER2/neu overexpression or amplification.
- •Received any prior treatment for primary invasive breast cancer.
- •Received any GnRH analog or SERM or AI within 12 months prior
- •to randomization
- •Previous (less than 10 years) or current history of malignant
- •neoplasms, except for curatively treated:
- •-Basal and squamous cell carcinoma of the skin
- •-Carcinoma in situ of the cervix
- •-Carcinoma in situ of the bladder
- •Diagnosis of inflammatory breast cancer
- •Bilateral invasive breast cancer
- •Known history of uncontrolled or symptomatic angina, clinically
- •significant arrhythmias, congestive heart failure, transmural
- •myocardial infarction uncontrolled hypertension (= 180/110),
- •unstable diabetes mellitus, dyspnea at rest, or chronic therapy
- •with oxygen
- •Concurrent disease or condition that would make the subject
- •inappropriate for study participation or any serious medical
- •disorder that would interfere with the subject’s safety
- •Unresolved or unstable, serious adverse events from prior
- •administration of another investigational drug
- •Active or uncontrolled infection CTCAE v.4 grade 2 or higher
- •Dementia, altered mental status, or any psychiatric condition
- •that would prevent the understanding or rendering of Informed
- •Treatment with an investigational agent must have stopped at
- •least 30 days before randomization
- •Pregnant or lactating women. Lactation has to stop before
- •randomization.
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